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Objective: One of the greatest challenges in clinical trial design is dealing with the subjectivity and variability introduced by human raters when measuring clinical end-points. We hypothesized that robotic measures that capture the kinematics of human movements collected longitudinally in patients after stroke would bear a significant relationship to the ordinal clinical scales and potentially lead to the development of more sensitive motor biomarkers that could improve the efficiency and cost of clinical trials., Materials and Methods: We used clinical scales and a robotic assay to measure arm movement in 208 patients 7, 14, 21, 30 and 90 days after acute ischemic stroke at two separate clinical sites. The robots are low impedance and low friction interactive devices that precisely measure speed, position and force, so that even a hemiparetic patient can generate a complete measurement profile. These profiles were used to develop predictive models of the clinical assessments employing a combination of artificial ant colonies and neural network ensembles., Results: The resulting models replicated commonly used clinical scales to a cross-validated R2 of 0.73, 0.75, 0.63 and 0.60 for the Fugl-Meyer, Motor Power, NIH stroke and modified Rankin scales, respectively. Moreover, when suitably scaled and combined, the robotic measures demonstrated a significant increase in effect size from day 7 to 90 over historical data (1.47 versus 0.67)., Discussion and Conclusion: These results suggest that it is possible to derive surrogate biomarkers that can significantly reduce the sample size required to power future stroke clinical trials., Competing Interests: The authors have read the journal’s policy and the authors of this manuscript have the following competing interests: AD and MK are employed by Janssen Research & Development, DA and EY were employed by Janssen Research & Development when this work was conducted and are currently employed by Novartis Institutes for BioMedical Research, GL is employed by GSL Statistical Consulting, GB is employed by Bioconstat Bvba, and JC is employed by Biogen-Idec. Wyeth provided grant funding for the study to HIK. This does not alter our adherence to PLOS ONE policies on sharing data and materials. HIK was also the founder of Interactive Motion Technologies and Chairman of the Board from 1998 to 2016. He sold Interactive Motion Technologies on April 2016 to Bionik Laboratories, where he served as Chief Science Officer and Board Member until July 2017. HIK holds equity positions in Interactive Motion Technologies, Watertown, MA, USA, the company that manufactures this type of technology under license from MIT. HIK was the founder of 4Motion Robotics. The authors would like to declare the following patents/patent applications associated with this research: HIK is a co-inventor in patents held by the Massachusetts Institute of Technology for the robotic technology used in this work (US Patent 7,618,381, US Patent 5,466,213, and US Patent App. 11/154,197).

Objective: To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved., Design: Descriptive analysis of data on fidelity, goal selection and achievement from an intervention group within a randomized controlled trial., Setting: Out-patient stroke rehabilitation within four UK NHS centres., Subjects: 259 participants with moderate-severe upper limb activity limitation (Action Research Arm Test 0-39) between one week and five years post first stroke., Intervention: The enhanced upper limb therapy programme aimed to provide 36 one-hour sessions, including 45 minutes of face-to-face therapy focusing on personal goals, over 12 weeks., Results: 7877/9324 (84%) sessions were attended; a median of 34 [IQR 29-36] per participant. A median of 127 [IQR 70-190] repetitions were achieved per participant per session attended. Based upon the Canadian Occupational Performance Measure, goal categories were: self-care 1449/2664 (54%); productivity 374/2664 (14%); leisure 180/2664 (7%) and 'other' 661/2664 (25%). For the 2051/2664 goals for which data were available, 1287 (51%) were achieved, ranging between 27% by participants more than 12 months post stroke with baseline Action Research Arm Test scores 0-7, and 88% by those less than three months after stroke with scores 8-19., Conclusions: Intervention fidelity was high. Goals relating to self-care were most commonly selected. The proportion of goals achieved varied, depending on time post stroke and baseline arm activity limitation.

Background: Loss of arm function is common after stroke. Robot-assisted training may improve arm outcomes., Objective: The objectives were to determine the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an enhanced upper limb therapy programme and with usual care., Design: This was a pragmatic, observer-blind, multicentre randomised controlled trial with embedded health economic and process evaluations., Setting: The trial was set in four NHS trial centres., Participants: Patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following first stroke, were recruited., Interventions: Robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme comprising repetitive functional task practice, and usual care., Main Outcome Measures: The primary outcome was upper limb functional recovery 'success' (assessed using the Action Research Arm Test) at 3 months. Secondary outcomes at 3 and 6 months were the Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), activities of daily living (measured using the Barthel Activities of Daily Living Index), quality of life (measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years., Results: A total of 770 participants were randomised (robot-assisted training, n  = 257; enhanced upper limb therapy, n  = 259; usual care, n  = 254). Upper limb functional recovery 'success' was achieved in the robot-assisted training [103/232 (44%)], enhanced upper limb therapy [118/234 (50%)] and usual care groups [85/203 (42%)]. These differences were not statistically significant; the adjusted odds ratios were as follows: robot-assisted training versus usual care, 1.2 (98.33% confidence interval 0.7 to 2.0); enhanced upper limb therapy versus usual care, 1.5 (98.33% confidence interval 0.9 to 2.5); and robot-assisted training versus enhanced upper limb therapy, 0.8 (98.33% confidence interval 0.5 to 1.3). The robot-assisted training group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months. The enhanced upper limb therapy group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the usual care group, at 3 months. The robot-assisted training group performed less well in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the enhanced upper limb therapy group at 3 months. No other differences were clinically important and statistically significant. Participants found the robot-assisted training and the enhanced upper limb therapy group programmes acceptable. Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence willingness-to-pay thresholds for a quality-adjusted life-year., Conclusions: Robot-assisted training did not improve upper limb function compared with usual care. Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes. Enhanced upper limb therapy resulted in potentially important improvements on upper limb impairment, in performance of activities of daily living, and in mobility. Neither intervention was cost-effective., Future Work: Further research is needed to find ways to translate the improvements in upper limb impairment seen with robot-assisted training into improvements in upper limb function and activities of daily living. Innovations to make rehabilitation programmes more cost-effective are required., Limitations: Pragmatic inclusion criteria led to the recruitment of some participants with little prospect of recovery. The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias. Obtaining accurate information about the usual care that participants were receiving was a challenge., Trial Registration: Current Controlled Trials ISRCTN69371850., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 54. See the NIHR Journals Library website for further project information.

Background . Robot-assisted therapy provides high-intensity arm rehabilitation that can significantly reduce stroke-related upper extremity (UE) deficits. Motor improvement has been shown at the joints trained, but generalization to real-world function has not been profound. Objective . To investigate the efficacy of robot-assisted therapy combined with therapist-assisted task training versus robot-assisted therapy alone on motor outcomes and use in participants with moderate to severe chronic stroke-related arm disability. Methods . This was a single-blind randomized controlled trial of two 12-week robot-assisted interventions; 45 participants were stratified by Fugl-Meyer (FMA) impairment (mean 21 ± 1.36) to 60 minutes of robot therapy (RT; n = 22) or 45 minutes of RT combined with 15 minutes therapist-assisted transition-to-task training (TTT; n = 23). The primary outcome was the mean FMA change at week 12 using a linear mixed-model analysis. A subanalysis included the Wolf Motor Function Test (WMFT) and Stroke Impact Scale (SIS), with significance P <.05. Results . There was no significant 12-week difference in FMA change between groups, and mean FMA gains were 2.87 ± 0.70 and 4.81 ± 0.68 for RT and TTT, respectively. TTT had greater 12-week secondary outcome improvements in the log WMFT (-0.52 ± 0.06 vs -0.18 ± 0.06; P = .01) and SIS hand (20.52 ± 2.94 vs 8.27 ± 3.03; P = .03). Conclusion . Chronic UE motor deficits are responsive to intensive robot-assisted therapy of 45 or 60 minutes per session duration. The replacement of part of the robotic training with nonrobotic tasks did not reduce treatment effect and may benefit stroke-affected hand use and motor task performance.

Background: Loss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care., Methods: RATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850., Findings: Between April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70-1·96]) and EULT (aOR 1·51 [0·90-2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48-1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention., Interpretation: Robot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice., Funding: National Institute for Health Research Health Technology Assessment Programme., (Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

The MIT-Skywalker is a robotic device developed for the rehabilitation of gait and balance after a neurological injury. This device has been designed based on the concept of a passive walker and provides three distinct training modes: discrete movement, rhythmic movement, and balance training. In this paper, we present our efforts to evaluate the comfort of a bicycle/saddle seat design for the system's novel actuated body weight support device. We employed different bicycle and saddle seats and evaluated comfort using objective and subjective measures. Here we will summarize the results obtained from a study of fifteen healthy subjects and one stroke patient that led to the selection of a saddle seat design for the MIT-Skywalker.

Rehabilitation robotic systems may afford better care and telerehabilitation may extend the use and benefits of robotic therapy to the home. Data transmissions over distance are bound by intrinsic communication delays which can be significant enough to deem the activity unfeasible. Here we describe an approach that combines unilateral robotic telerehabilitation and serious games. This approach has a modular and distributed design that permits different types of robots to interact without substantial code changes. We demonstrate the approach through an online multiplayer game. Two users can remotely interact with each other with no force exchanges, while a smoothing and prediction algorithm compensates motions for the delay in the Internet connection. We demonstrate that this approach can successfully compensate for data transmission delays, even when testing between the United States and Brazil. This paper presents the initial experimental results, which highlight the performance degradation with increasing delays as well as improvements provided by the proposed algorithm, and discusses planned future developments.

This paper describes our efforts to employ the Microsoft Kinect as a low cost vision control system for the MIT-Skywalker, a robotic gait rehabilitation device. The Kinect enables an alternative markerless solution to control the MIT-Skywalker and allows a more user-friendly set-up. A study involving eight healthy subjects and two stroke survivors using the MIT-Skywalker device demonstrates the advantages and challenges of this new proposed approach.

Background: An unsettled question in the use of robotics for post-stroke gait rehabilitation is whether task-specific locomotor training is more effective than targeting individual joint impairments to improve walking function. The paretic ankle is implicated in gait instability and fall risk, but is difficult to therapeutically isolate and refractory to recovery. We hypothesize that in chronic stroke, treadmill-integrated ankle robotics training is more effective to improve gait function than robotics focused on paretic ankle impairments., Findings: Participants with chronic hemiparetic gait were randomized to either six weeks of treadmill-integrated ankle robotics (n = 14) or dose-matched seated ankle robotics (n = 12) videogame training. Selected gait measures were collected at baseline, post-training, and six-week retention. Friedman, and Wilcoxon Sign Rank and Fisher's exact tests evaluated within and between group differences across time, respectively. Six weeks post-training, treadmill robotics proved more effective than seated robotics to increase walking velocity, paretic single support, paretic push-off impulse, and active dorsiflexion range of motion. Treadmill robotics durably improved gait dorsiflexion swing angle leading 6/7 initially requiring ankle braces to self-discarded them, while their unassisted paretic heel-first contacts increased from 44 % to 99.6 %, versus no change in assistive device usage (0/9) following seated robotics., Conclusions: Treadmill-integrated, but not seated ankle robotics training, durably improves gait biomechanics, reversing foot drop, restoring walking propulsion, and establishing safer foot landing in chronic stroke that may reduce reliance on assistive devices. These findings support a task-specific approach integrating adaptive ankle robotics with locomotor training to optimize mobility recovery., Clinical Trial Identifier: NCT01337960. https://clinicaltrials.gov/ct2/show/NCT01337960?term=NCT01337960&rank=1.

Background and Purpose: Because robotic devices record the kinematics and kinetics of human movements with high resolution, we hypothesized that robotic measures collected longitudinally in patients after stroke would bear a significant relationship to standard clinical outcome measures and, therefore, might provide superior biomarkers., Methods: In patients with moderate-to-severe acute ischemic stroke, we used clinical scales and robotic devices to measure arm movement 7, 14, 21, 30, and 90 days after the event at 2 clinical sites. The robots are interactive devices that measure speed, position, and force so that calculated kinematic and kinetic parameters could be compared with clinical assessments., Results: Among 208 patients, robotic measures predicted well the clinical measures (cross-validated R(2) of modified Rankin scale=0.60; National Institutes of Health Stroke Scale=0.63; Fugl-Meyer=0.73; Motor Power=0.75). When suitably scaled and combined by an artificial neural network, the robotic measures demonstrated greater sensitivity in measuring the recovery of patients from day 7 to day 90 (increased standardized effect=1.47)., Conclusions: These results demonstrate that robotic measures of motor performance will more than adequately capture outcome, and the altered effect size will reduce the required sample size. Reducing sample size will likely improve study efficiency.

Objectives: To determine the efficacy of 2 distinct 6-week robot-assisted reaching programs compared with an intensive conventional arm exercise program (ICAE) for chronic, stroke-related upper-extremity (UE) impairment. To examine whether the addition of robot-assisted training out of the horizontal plane leads to improved outcomes., Design: Randomized controlled trial, single-blinded, with 12-week follow-up., Setting: Research setting in a large medical center., Participants: Adults (N=62) with chronic, stroke-related arm weakness stratified by impairment severity using baseline UE motor assessments., Interventions: Sixty minutes, 3 times a week for 6 weeks of robot-assisted planar reaching (gravity compensated), combined planar with vertical robot-assisted reaching, or intensive conventional arm exercise program., Main Outcome Measure: UE Fugl-Meyer Assessment (FMA) mean change from baseline to final training., Results: All groups showed modest gains in the FMA from baseline to final with no significant between group differences. Most change occurred in the planar robot group (mean change ± SD, 2.94 ± 0.77; 95% confidence interval [CI], 1.40-4.47). Participants with greater motor impairment (n=41) demonstrated a larger difference in response (mean change ± SD, 2.29 ± 0.72; 95% CI, 0.85-3.72) for planar robot-assisted exercise compared with the intensive conventional arm exercise program (mean change ± SD, 0.43 ± 0.72; 95% CI, -1.00 to 1.86)., Conclusions: Chronic UE deficits because of stroke are responsive to intensive motor task training. However, training outside the horizontal plane in a gravity present environment using a combination of vertical with planar robots was not superior to training with the planar robot alone., (Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness., Methods: We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization., Results: A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different., Conclusions: The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00372411.

Our objective in this study was to assess passive mechanical stiffness in the ankle of chronic hemiparetic stroke survivors and to compare it with those of healthy young and older (age-matched) individuals. Given the importance of the ankle during locomotion, an accurate estimate of passive ankle stiffness would be valuable for locomotor rehabilitation, potentially providing a measure of recovery and a quantitative basis to design treatment protocols. Using a novel ankle robot, we characterized passive ankle stiffness both in sagittal and in frontal planes by applying perturbations to the ankle joint over the entire range of motion with subjects in a relaxed state. We found that passive stiffness of the affected ankle joint was significantly higher in chronic stroke survivors than in healthy adults of a similar cohort, both in the sagittal as well as frontal plane of movement, in three out of four directions tested with indistinguishable stiffness values in plantarflexion direction. Our findings are comparable to the literature, thus indicating its plausibility, and, to our knowledge, report for the first time passive stiffness in the frontal plane for persons with chronic stroke and older healthy adults.

Robotic technology can provide innovative responses to the severe challenges of providing cost-effective care to restore sensory-motor function following neurological and biomechanical injury. It may be deployed at several points on a continuum of care, to provide precisely controlled sensory-motor therapy to ameliorate disability and promote recovery of function, or to provide assistance to compensate for functions that cannot be recovered, or to replace limbs lost irretrievably. This chapter reviews recent progress using robotic technology to capitalize on neural plasticity and promote recovery after neurological injury such as stroke (cerebral vascular accident), research on brain-computer interfaces as a source of control signals for assistive technologies, and research on high-performance multiple-degree-of-freedom upper-extremity prosthetic limbs., (Copyright © 2011 Elsevier B.V. All rights reserved.)

In this paper, we present a retrospective review of our efforts to revolutionize the way physical medicine is practiced by developing and deploying rehabilitation robots. We present a sample of our clinical results with well over 600 stroke patients, both inpatients and outpatients. We discuss the different robots developed at our laboratory over the past 20 years and their unique characteristics. All are configured both to deliver reproducible interactive therapy and also to measure outcomes with minimal encumbrance, thus providing critical measurement tools to help unravel the key remaining question: what constitutes "best practice"? While success to date indicates that this therapeutic application of robots has opened an emerging new frontier in physical medicine and rehabilitation, the barrier to further progress lies not in developing new hardware but rather in finding the most effective way to enhance neuro-recovery. We close this manuscript discussing some of the tools required for advancing the effort beyond the present state to what we believe will be the central feature of research during the next 10 years.

In this paper we present the alpha-prototype of a novel pediatric ankle robot. This lower-extremity robotic therapy module was developed at MIT to aid recovery of ankle function in children with cerebral palsy ages 5 to 8 years old. This lower-extremity robotic module will commence pilot testing with children with cerebral palsy at Blythedale Childrens Hospital (Valhalla, NY), Bambino Gesu Children's Hospital (Rome, Italy), Riley Children's Hospital (Indianapolis, IN). Its design follows the same guidelines as our upper-extremity robots and adult anklebot designs, i.e. it is a low friction, backdriveable device with intrinsically low mechanical impedance. We show the ankle robot characteristics and stability range. We also present pilot data with healthy children to demonstrate the potential of this device., (© 2011 IEEE)

In this paper, we discuss a strategy for the adaptation of the "difficulty level" in games intended to include motor planning during robotic rehabilitation. We consider concurrently the motivation of the user and his/her performance in a Pong game. User motivation is classified in three levels (not motivated, well motivated and overloaded). User performance is measured as a combination of knowledge of results--achieved goals and score points in the game--and knowledge of performance--joint displacement, speed, aiming, user work, etc. Initial results of a pilot test with unimpaired healthy young volunteers are also presented showing a tendency for individualization of the parameter values.

Background: Hemiparesis after stroke often leads to impaired ankle motor control that impacts gait function. In recent studies, robotic devices have been developed to address this impairment. While capable of imparting forces to assist during training and gait, these devices add mass to the paretic leg which might encumber patients' gait pattern. The purpose of this study was to assess the effects of the added mass of one of these robots, the MIT's Anklebot, while unpowered, on gait of chronic stroke survivors during overground and treadmill walking., Methods: Nine chronic stroke survivors walked overground and on a treadmill with and without the anklebot mounted on the paretic leg. Gait parameters, interlimb symmetry, and joint kinematics were collected for the four conditions. Repeated-measures analysis of variance (ANOVA) tests were conducted to examine for possible differences across four conditions for the paretic and nonparetic leg., Results: The added inertia and friction of the unpowered anklebot had no statistically significant effect on spatio-temporal parameters of gait, including paretic and nonparetic step time and stance percentage, in both overground and treadmill conditions. Noteworthy, interlimb symmetry as characterized by relative stance duration was greater on the treadmill than overground regardless of loading conditions. The presence of the unpowered robot loading reduced the nonparetic knee peak flexion on the treadmill and paretic peak dorsiflexion overground (p < 0.05)., Conclusions: Our results suggest that for these subjects the added inertia and friction of this backdriveable robot did not significantly alter their gait pattern.

Background: Effective rehabilitative therapies are needed for patients with long-term deficits after stroke., Methods: In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks., Results: At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported., Conclusions: In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.), (2010 Massachusetts Medical Society)

Background: Chronic upper extremity impairment due to stroke has significant medical, psychosocial, and financial consequences, but few studies have examined the effectiveness of rehabilitation therapy during the chronic stroke period., Objective: . To test the safety and efficacy of the MIT-Manus robotic device for chronic upper extremity impairment following stroke., Methods: . The VA Cooperative Studies Program initiated a multicenter, randomized, controlled trial in November 2006 (VA ROBOTICS). Participants with upper extremity impairment >/=6 months poststroke were randomized to robot-assisted therapy (RT), intensive comparison therapy (ICT), or usual care (UC). RT and ICT consisted of three 1-hour treatment sessions per week for 12 weeks. The primary outcome was change in the Fugl-Meyer Assessment upper extremity motor function score at 12 weeks relative to baseline. Secondary outcomes included the Wolf Motor Function Test and the Stroke Impact Scale., Results: . A total of 127 participants were randomized: 49 to RT, 50 to ICT, and 28 to UC. The majority of participants were male (96%), with a mean age of 65 years. The primary stroke type was ischemic (85%), and 58% of strokes occurred in the anterior circulation. Twenty percent of the participants reported a stroke in addition to their index stroke. The average time from the index stroke to enrollment was 56 months (range, 6 months to 24 years). The mean Fugl-Meyer score at entry was 18.9., Conclusions: . VA ROBOTICS demonstrates the feasibility of conducting multicenter clinical trials to rigorously test new rehabilitative devices before their introduction to clinical practice. The results are expected in early 2010.

Our goal was to examine the feasibility of applying therapeutic robotics to children and adults with severe to moderate impairment due to cerebral palsy (CP). Pilot results demonstrated significant gains for both groups. These results suggest that robot-mediated therapy may be an effective tool to ameliorate the debilitating effects of CP and provide new opportunities for reducing impairment and improving coordination.

The understanding that recovery of brain function after stroke is imperfect has prompted decades of effort to engender speedier and better recovery through environmental manipulation. Clinical evidence has shown that the performance plateau exhibited by patients with chronic stroke, usually signaling an end of standard rehabilitation, might represent a period of consolidation rather than a performance optimum. These results highlight the difficulty of translating pertinent neurological data into pragmatic changes in clinical programs. This opinion piece focuses on upper limb impairment reduction after robotic training. We propose that robotic devices be considered as novel tools that might be used alone or in combination with novel pharmacology and other bioengineered devices. Additionally, robotic devices can measure motor performance objectively and will contribute to a detailed phenotype of stroke recovery.

We are expanding the use of the MIT-MANUS robotics to persons with impairments due exclusively to orthopedic disorders, with no neurological deficits. To understand the reliability of repeated measurements of the robotic tasks and the potential for registering changes due to learning is critical. Purposes of this study were to assess the learning effect of repeated exposure to robotic evaluations and to demonstrate the ability to detect a change in protocol in outcome measurements. Ten healthy, unimpaired subjects (mean age = 54.1 +/- 6.4 years) performed six repeated evaluations consisting of unconstrained reaching movements to targets and circle drawing (with and without a visual template) on the MITMANUS. Reaching outcomes were aiming error, mean and peak speed, movement smoothness and duration. Outcomes for circle drawing were axis ratio metric and shoulder- elbow joint angles correlation metric (was based on a two-link model of the human arm and calculated hand path during the motions). Repeated-measures ANOVA (p < or = .05) determined if difference existed between the sessions. Intraclass correlations (R) were calculated. All variables were reliable, without learning across testing sessions. Intraclass correlation values were good to high (reaching, R > or =.80; circle drawing, R > or =.90). Robotic measurement ability to differentiate between similar but distinct tasks was demonstrated as measured by axis ratio metric (p < .001) and joint correlation metric (p = .001). Outcome measures of the MIT-MANUS proved to be reliable yet sensitive to change in healthy adults without motor learning over the course of repeated measurements.

Investigators have demonstrated that a variety of intensive movement training protocols for persistent upper limb paralysis in patients with chronic stroke (6 months or more after stroke) improve motor outcome. This randomized controlled study determined in patients with upper limb motor impairment after chronic stroke whether movement therapy delivered by a robot or by a therapist using an intensive training protocol was superior. Robotic training (n = 11) and an intensive movement protocol (n = 10) improved the impairment measures of motor outcome significantly and comparably; there were no significant changes in disability measures. Motor gains were maintained at the 3-month evaluation after training. These data contribute to the growing awareness that persistent impairments in those with chronic stroke may not reflect exhausted capacity for improvement. These new protocols, rendered by either therapist or robot, can be standardized, tested, and replicated, and potentially will contribute to rational activity-based programs.

Objective: The aim of the study was to present a systematic review of studies that investigate the effects of robot-assisted therapy on motor and functional recovery in patients with stroke., Methods: A database of articles published up to October 2006 was compiled using the following Medline key words: cerebral vascular accident, cerebral vascular disorders, stroke, paresis, hemiplegia, upper extremity, arm, and robot. References listed in relevant publications were also screened. Studies that satisfied the following selection criteria were included: (1) patients were diagnosed with cerebral vascular accident; (2) effects of robot-assisted therapy for the upper limb were investigated; (3) the outcome was measured in terms of motor and/or functional recovery of the upper paretic limb; and (4) the study was a randomized clinical trial (RCT). For each outcome measure, the estimated effect size (ES) and the summary effect size (SES) expressed in standard deviation units (SDU) were calculated for motor recovery and functional ability (activities of daily living [ADLs]) using fixed and random effect models. Ten studies, involving 218 patients, were included in the synthesis. Their methodological quality ranged from 4 to 8 on a (maximum) 10-point scale., Results: Meta-analysis showed a nonsignificant heterogeneous SES in terms of upper limb motor recovery. Sensitivity analysis of studies involving only shoulder-elbow robotics subsequently demonstrated a significant homogeneous SES for motor recovery of the upper paretic limb. No significant SES was observed for functional ability (ADL)., Conclusion: As a result of marked heterogeneity in studies between distal and proximal arm robotics, no overall significant effect in favor of robot-assisted therapy was found in the present meta-analysis. However, subsequent sensitivity analysis showed a significant improvement in upper limb motor function after stroke for upper arm robotics. No significant improvement was found in ADL function. However, the administered ADL scales in the reviewed studies fail to adequately reflect recovery of the paretic upper limb, whereas valid instruments that measure outcome of dexterity of the paretic arm and hand are mostly absent in selected studies. Future research into the effects of robot-assisted therapy should therefore distinguish between upper and lower robotics arm training and concentrate on kinematical analysis to differentiate between genuine upper limb motor recovery and functional recovery due to compensation strategies by proximal control of the trunk and upper limb.

Robotics and related technologies have begun to realize their promise to improve the delivery of rehabilitation therapy. However, the mechanism by which they enhance recovery remains unclear. Ultimately, recovery depends on biology, yet the details of the recovery process remain largely unknown; a deeper understanding is important to accelerate refinements of robotic therapy or suggest new approaches. Fortunately, robots provide an excellent instrument platform from which to study recovery at the behavioral level. This article reviews some initial insights about the process of upper-limb behavioral recovery that have emerged from our work. Evidence to date suggests that the form of therapy may be more important than its intensity: muscle strengthening offers no advantage over movement training. Passive movement is insufficient; active participation is required. Progressive training based on measures of movement coordination yields substantially improved outcomes. Together these results indicate that movement coordination rather than muscle activation may be the most appropriate focus for robotic therapy.

The potential for remote diagnosis and treatment over the Internet using robotics is now a reality. The state of the art is exemplified by several Internet applications, and we explore the current trends in developing new systems. We review the technical challenges that lie ahead, along with some potential solutions. Some promising results for a new bilateral system involving two InMotion2 robots are presented. Finally, we discuss the future direction and commercial outlook for rehabilitation robots over the next 15 years.

Twelve moderately to severely involved chronic stroke survivors (>12 mo) were randomized to one of two treatments: robotics and motor learning (ROB-ML) or functional neuromuscular stimulation and motor learning (FNS-ML). Treatment was 5 h/d, 5 d/wk for 12 wk. ROB-ML group had 1.5 h per session devoted to robotics shoulder and elbow (S/E) training. FNS-ML had 1.5 h per session devoted to functional neuromuscular stimulation (surface electrodes) for wrist and hand (W/H) flexors/extensors. The primary outcome measure was the functional measure Arm Motor Ability Test (AMAT). Secondary measures were AMAT-S/E and AMAT-W/H, Fugl-Meyer (FM) upper-limb coordination, and the motor control measures of target accuracy (TA) and smoothness of movement (SM). ROB-ML produced significant gains in AMAT, AMAT-S/E, FM upper-limb coordination, TA, and SM. FNS-ML produced significant gains in AMAT-W/H and FM upper-limb coordination.

Stroke is the leading cause of permanent disability in the United States despite advances in prevention and novel interventional treatments. Randomized controlled studies have demonstrated the effectiveness of specialized post-stroke rehabilitation units, but administrative orders have severely limited the length of stay, so novel approaches to the treatment of recovery need to be tested in outpatients. Although the mechanisms of stroke recovery depend on multiple factors, a number of techniques that concentrate on enhanced exercise of the paralyzed limb have demonstrated effectiveness in reducing the motor impairment. For example, interactive robotic devices are new tools for therapists to deliver enhanced sensorimotor training for the paralyzed upper limb, which can potentially improve patient outcome and increase patient productivity. New data support the idea that for some post-stroke patients and for some aspects of training-induced recovery, timing of the training may be less important than the quality and intensity of the training. The positive outcome that resulted in the interactive robotic trials contrasts with the failure to find a beneficial result in trials that used a noninteractive device that delivered continuous passive motion only. New pilot data from novel devices to move the wrist demonstrate benefit and suggest that successive improvement of the function of the arm progressing to the distal muscles may eventually lead to significant disability reduction. These data from robotic trials continue to contribute to the emerging scientific basis of neuro-rehabilitation.

This pilot study tested the effectiveness of an intense, short-term upper-limb robotic therapy for improvement in motor outcomes among chronic stroke patients. We enrolled 30 subjects with upper-limb deficits due to stroke of at least 6 mo duration and with a Motor Power Assessment grade of 3 or less. Over 3 wk, 18 sessions of robot-assisted task-specific therapy were delivered with the use of a robotic exercise device that simulates a conventional therapy known as skateboard therapy. Primary outcome measures included reliable, validated impairment and disability measures of upper-limb motor function. Statistically significant improvements were observed for severely impaired participants when we compared baseline and posttreatment outcomes (p < 0.05). These results are important because they indicate that improvement is not limited to those with moderate impairments but is possible among severely impaired chronic stroke patients as well. Moderately and severely impaired patients in our study were able to tolerate a massed-practice therapy paradigm with intensive, frequent, and repetitive treatment. This information is useful in determining the optimal target population, intensity, and duration of robotic therapy and sample size for a planned larger trial.

Chronic motor deficits in the upper limb (UL) are a major contributor to disability following stroke. This study investigated the effect of short-duration robot-assisted therapy on motor impairment, as measured by clinical scales and robot-derived performance measures in patients with chronic, severe UL impairments after stroke. As part of a larger study, 15 individuals with chronic, severe UL paresis (Fugl-Meyer < 15) after stroke (minimum 6 mo postonset) performed 18 sessions of robot-assisted UL rehabilitation that consisted of goal-directed planar reaching tasks over a period of 3 weeks. Outcome measures included the Fugl-Meyer Assessment, the Motor Power Assessment, the Wolf Motor Function Test, the Stroke Impact Scale, and five robot-derived measures that reflect motor control (aiming error, mean speed, peak speed, mean:peak speed ratio, and movement duration). Robot-assisted training produced statistically significant improvements from baseline to posttreatment in the Fugl-Meyer and Motor Power Assessment scores and the quality of motion (quantified by a reduction in aiming error and movement duration with an increase in mean speed and mean:peak speed ratio). Our findings indicate that robot-assisted UL rehabilitation can reduce UL impairment and improve motor control in patients with severe UL paresis from chronic stroke.

Research on the effectiveness of robotic therapy for the paretic upper limb after stroke has shown statistically significant reductions in motor impairment during both acute and chronic phases of recovery. Despite growing empirical support for this technology and a stronger focus on optimizing rehabilitation outcomes and productivity, there continues to be a disconnect between research and clinical practice. We review studies on the use of robot-aided neurorehabilitation for the paretic arm after stroke and discuss ways in which this technology may provide opportunities for intensive training that complement more conventional therapy methods.

Stroke is the leading cause of permanent disability in the United States despite advances in prevention and novel interventional treatments. Randomized controlled studies have demonstrated the effectiveness of specialized post-stroke rehabilitation units, but administrative orders have severely limited the length of stay, so novel approaches to the treatment of recovery need to be tested in outpatients. Although the mechanisms of stroke recovery depend on multiple factors, a number of techniques that concentrate on enhanced exercise of the paralyzed limb have demonstrated effectiveness in reducing the motor impairment. For example, interactive robotic devices are new tools for therapists to deliver enhanced sensorimotor training for the paralyzed upper limb, which can potentially improve patient outcome and increase their productivity. New data support the idea that for some post-stroke patients and for some aspects of training-induced recovery, timing of the training may be less important than the quality and intensity of the training. The positive outcome that resulted in the interactive robotic trials contrasts with the failure to find a beneficial result in trials that used a noninteractive device that delivered continuous passive motion only. New pilot data from novel devices to move the wrist demonstrate benefit and suggest that successive improvement of the function of the arm progressing to the distal muscles may eventually lead to significant disability reduction. These data from robotic trials continue to contribute to the emerging scientific basis of neuro-rehabilitation.

Objectives: To study the effects of robotic rehabilitation in persons with chronic motor impairments after stroke and to examine whether improvements in motor abilities were sustained 4 months after the end of therapy., Design: Pretest-posttest design., Setting: Rehabilitation hospital, outpatient care., Participants: Volunteer sample of 42 persons with persistent hemiparesis from a single, unilateral stroke within the past 1 to 5 years., Intervention: Robotic therapy for the paretic upper limb consisted of either sensorimotor active-assistive exercise, or progressive-resistive training during repetitive, planar reaching tasks, 3 times a week for 6 weeks., Main Outcome Measures: Modified Ashworth Scale, Fugl-Meyer Assessment (FMA), Motor Status Scale (MSS) score, and Medical Research Council motor power score., Results: No significant differences were found among pretreatment clinical evaluations. Statistically significant gains from admission to discharge and from admission to follow-up (P<.05) were found on the FMA, MSS score for shoulder and elbow, and motor power score., Conclusions: Short-term, goal-directed robotic therapy can significantly improve motor abilities of the exercised limb segments in persons with chronic stroke that are sustained 4 months after discharge. This suggests that motor recovery can be enhanced by repetitive exercise training more than 1 year after stroke.

This article reviews a decade of work aimed at developing effective interactive robotic tools to treat and understand motor impairment and disability. The success of an initial pilot study with acute-phase in-patients recovering from stroke prompted a larger study showing that these results could be replicated and a follow-up study showing that the benefits lasted. Studies of chronic-phase out-patients demonstrated that similar benefits could be obtained which also lasted and were accompanied by a concomitant reduction of pain. Exploration of the likely biology of recovery suggested an improvement of robotic treatment in the form of performance-based progressive therapy aimed at accelerating a process akin to motor learning postulated to underlie recovery. Initial studies of this method show a dramatic improvement over the previous successes. Kinematic studies of the recovery process show that, similar to the development of motor behavior in infants, it begins with stereotyped submovements and proceeds by progressively merging these to approach unimpaired motor performance.

Objective: To examine whether robotic therapy can reduce motor impairment and enhance recovery of the hemiparetic arm in persons with chronic stroke., Design: Pre-posttest design., Setting: Rehabilitation hospital, outpatient care., Participants: Volunteer sample of 20 persons diagnosed with a single, unilateral stroke within the past 1 to 5 years, with persistent hemiparesis., Interventions: Robotic therapy was provided 3 times weekly for 6 weeks. Subjects able to reach robot targets were randomly assigned to sensorimotor or progressive-resistive robotic therapy groups. Robotic therapy consisted of goal-directed, planar reaching tasks to exercise the hemiparetic shoulder and elbow., Main Outcome Measures: The Modified Ashworth Scale, Fugl-Meyer test of upper-extremity function, Motor Status Scale (MSS) score, and Medical Research Council motor power score., Results: Evaluations by a single blinded therapist revealed statistically significant gains from admission to discharge (P<.05) on the Fugl-Meyer test, MSS score, and motor power score. Secondary analyses revealed group differences: the progressive-resistive therapy group experienced nonspecific improvements on wrist and hand MSS scores that were not observed in the sensorimotor group., Conclusions: Robotic therapy may complement other treatment approaches by reducing motor impairment in persons with moderate to severe chronic impairments.

Stroke is the leading cause of permanent disability despite continued advances in prevention and novel interventional treatments. Post-stroke neuro-rehabilitation programs teach compensatory strategies that alter the degree of permanent disability. Robotic devices are new tools for therapists to deliver enhanced sensorimotor training and concentrate on impairment reduction. Results from several groups have registered success in reducing impairment and increasing motor power with task-specific exercise delivered by the robotic devices. Enhancing the rehabilitation experience with task-specific repetitive exercise marks a different approach to the patient with stroke. The clinical challenge will be to streamline, adapt, and expand the robot protocols to accommodate healthcare economies, to determine which patients sustain the greatest benefit, and to explore the relationship between impairment reduction and disability level. With these new tools, therapists will measure aspects of outcome objectively and contribute to the emerging scientific basis of neuro-rehabilitation.

Mechanical impedance of the ankle is known to influence key aspects of ankle function. We investigated the effects of robot-assisted ankle training in people with chronic stroke on the paretic ankle’s passive stiffness and its relationship to overground gait function. Over 6 wk, eight participants with residual hemiparetic deficits engaged in a visuomotor task while seated that required dorsiflexion (DF) or plantar flexion (PF) of their paretic ankle with an ankle robot (“anklebot”) assisting as needed. Passive ankle stiffness (PAS) was measured in both the trained sagittal and untrained frontal planes. After 6 wk, the PAS decreased in both DF and PF and reverted into the variability of age-matched controls in DF. Changes in PF PAS correlated strongly with gains in paretic step lengths (Spearman rho = 0.88, p = 0.03) and paretic stride lengths (Spearman rho = 0.82, p = 0.05) during independent floor walking. Moreover, baseline PF PAS were correlated with gains in paretic step lengths (Spearman rho = 0.94, p = 0.01), paretic stride lengths (Spearman rho = 0.83, p = 0.05), and single-support stance duration (Spearman rho = 0.94, p = 0.01); and baseline eversion PAS were correlated with gains in cadence (Spearman rho = 0.88, p = 0.03). These findings suggest that ankle robot-assisted, visuomotor-based, isolated ankle training has a positive effect on paretic ankle PAS that strongly influences key measures of gait function. [ABSTRACT FROM AUTHOR]

Abstract: Robot-aided neuro-rehabilitation is increasingly being incorporated into rehabilitation practices. The aim of this study was to search for patterns in the data acquired by a robot in the baseline evaluation session which could predict progress over the next therapy sessions. Kinematic and kinetic data were acquired during robot-mediated evaluation sessions of 12 children with motor impairments due to hemiplegic cerebral palsy (CP). Time and wavelets features were extracted from the data and used for K-means clustering. The data were labeled by the Quality of Upper Extremity Skills Test (QUEST) and the gradient of improvement change in the QUEST between the baseline assessment and therapy follow-up one month after completion of 16 robot-mediated therapy sessions. Two distinct clusters segregated these 12 children into performers and non-performers in terms of the QUEST. [Copyright &y& Elsevier]

Background: Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation). This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions). Results: Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. Conclusion: Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on experiments that test whether we can continue to influence recovery, long after the acute insult, with a novel class of spatial robotic devices. This pilot results support the pursuit of further clinical trials to test efficacy and the pursuit of optimal therapy following brain injury. [ABSTRACT FROM AUTHOR]