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Study design:Survey of expert opinion, feedback and final consensus.Objective:To describe the development and the variables included in the International Spinal Cord Injury (SCI) Spinal Interventions and Surgical Procedures Basic Data set.Setting:International working group.Methods:A committee of experts was established to select and define data elements. The data set was then disseminated to the appropriate committees and organizations for comments. All suggested revisions were considered and both the International Spinal Cord Society and the American Spinal Injury Association endorsed the final version.Results:The data set consists of nine variables: (1) Intervention/Procedure Date and start time (2) Non-surgical bed rest and external immobilization, (3) Spinal intervention-closed manipulation and/or reduction of spinal elements, (4) Surgical procedure-approach, (5) Date and time of the completion of the intervention or surgical closure; (6) Surgical procedure-open reduction, (7) Surgical procedure-direct decompression of neural elements, and (8 and 9) Surgical procedure-stabilization and fusion (spinal segment number and level). All variables are coded using numbers or characters. Each spinal intervention and procedure is coded (variables 1 through 7) and the spinal segment level is described (variables 8 and 9). Sample clinical cases were developed to illustrate how to complete it.Conclusion:The International SCI Spinal Interventions and Surgical Procedures Basic Data Set was developed to facilitate comparisons of spinal interventions and surgical procedures among studies, centers and countries. [ABSTRACT FROM AUTHOR]

The International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) is routinely used to determine levels of injury and to classify the severity of the injury. Questions are often posed to the International Standards Committee of the American Spinal Injury Association (ASIA) regarding the classification. The committee felt that disseminating some of the challenging questions posed, as well as the responses, would be of benefit for professionals utilizing the ISNCSCI. Case scenarios that were submitted to the committee are presented with the responses as well as the thought processes considered by the committee members. The importance of this documentation is to clarify some points as well as update the SCI community regarding possible revisions that will be needed in the future based upon some rules that require clarification. [ABSTRACT FROM AUTHOR]

Background:Disability scales do not enable the transmission of concise, meaningful and daily function description for clinical purposes.Study design:Cross-sectional statistical analysis of 328 patients' Spinal Cord Independence Measure (SCIM) III item scores (SIS).Objective:To develop a concise and clinically interpretable data-based characterization of daily task accomplishment for patients with spinal cord lesions (SCLs).Setting:Multi-center study at 13 spinal units in 6 countries.Methods:Patients were grouped into clusters characterized by smaller differences between the patients' SIS within the clusters than between their centers, using the k-medoides algorithm. The number of clusters (k) was chosen according to the percent of SIS variation they explained and the clinical distinction between them.Results:Analysis showed that k=8 SIS clusters offer a good description of the patient population. The eight functional clusters were designated as A-H, each cluster (grade) representing a combination of task accomplishments. Higher grades were usually (but not always) associated with patients implementing more difficult tasks. Throughout rehabilitation, the patients' functional grade improved and the distribution of patients with similar functional grades within the total SCIM III score deciles remained stable.Conclusions:A new classification based on SIS clusters enables a concise description of overall functioning and task accomplishment distribution in patients with SCL. A software tool is used to identify the patients' functional grade. Findings support the stability and utility of the grades for characterizing the patients' functional status. [ABSTRACT FROM AUTHOR]

Aim. To describe sensitive cooperation as a basis for assisted feeding through the experiences of people with high cervical spinal cord injury (hcSCI). Background. People who contract a complete hcSCI will require lifelong assistance from others with all activities of daily living. Initially, they prefer getting help from people they already know and are reluctant to cooperate with personal assistants. Assisted feeding is a situation where the nature of the cooperation between the two parties involved is crucial. Design. Qualitative. Method. Sixteen people with hcSCI were interviewed twice within a period of eighteen months. The second interview was combined with an observation. Transcriptions of interviews and notes from the observations were analysed according to Reflective Lifeworld Research as described by Dahlberg and colleagues. Results. Sensitive cooperation implies genuine acquaintance and sincere concern for the person receiving help. It takes time to develop and it is not possible for the person who needs help to ask for sensitive cooperation. When a meal has to be based on cooperation with another human being it is no longer adjusted by the inner eating pace and rhythm of the person needing assisted feeding, but has the temporality of the helper as a necessary condition. A particular meal draws on the experiences from all previous meals and is a significant forerunner of future meals. Conclusions. Sensitive cooperation implies genuine acquaintance and sincere concern for the person receiving help. It takes time to develop and it is not possible for the person who needs help to ask for sensitive cooperation. When a meal has to be based on cooperation with another human being it is no longer adjusted by the inner eating pace and rhythm of the person needing assisted feeding, but has the temporality of the helper as a necessary condition. A particular meal draws on the experiences from all previous meals and is a significant forerunner of future meals. Relevance to clinical practice. Nurses and other health care professionals working within settings where people with hcSCI are admitted right after the injury have a responsibility to be meticulous when cooperating with the patients during assisted feeding. They create the basis for later cooperation with the personal assistants. Professionals working in institutions must assume that people with hcSCI are vulnerable and that assisted feeding should be carefully scheduled and conducted without interruption. Without this foundation, sensitive cooperation might never happen. [ABSTRACT FROM AUTHOR]

Study design:Experts opinions consensus.Objective:To develop a common strategy to document remaining autonomic neurologic function following spinal cord injury (SCI).Background and Rationale:The impact of a specific SCI on a person's neurologic function is generally described through use of the International Standards for the Neurological Classification of SCI. These standards document the remaining motor and sensory function that a person may have; however, they do not provide information about the status of a person's autonomic function.Methods:Based on this deficiency, the American Spinal Injury Association (ASIA) and the International Spinal Cord Society (ISCoS) commissioned a group of international experts to develop a common strategy to document the remaining autonomic neurologic function.Results:Four subgroups were commissioned: bladder, bowel, sexual function and general autonomic function. On-line communication was followed by numerous face to face meetings. The information was then presented in a summary format at a course on Measurement in Spinal Cord Injury, held on June 24, 2006. Subsequent to this it was revised online by the committee members, posted on the websites of both ASIA and ISCoS for comment and re-revised through webcasts. Topics include an overview of autonomic anatomy, classification of cardiovascular, respiratory, sudomotor and thermoregulatory function, bladder, bowel and sexual function.Conclusion:This document describes a new system to document the impact of SCI on autonomic function. Based upon current knowledge of the neuroanatomy of autonomic function this paper provides a framework with which to communicate the effects of specific spinal cord injuries on cardiovascular, broncho-pulmonary, sudomotor, bladder, bowel and sexual function. [ABSTRACT FROM AUTHOR]

AIM: This paper is a report of a study to explore the meaning of assisted feeding through the experiences of people with high cervical spinal cord injury. Background. Eating difficulties are known to affect a person's self-image and transform social lives. Little is known about the experience of assisted feeding as a permanent situation. METHOD: Sixteen people with high cervical spinal cord injury were interviewed twice within a period of 18 months in 2005-2006. The second interview was combined with observation. Transcriptions of interviews and notes from the observations were analysed using the phenomenological guidelines by Dahlberg and colleagues. FINDINGS: The essence of the phenomenon assisted feeding was described as a constructed pattern based on coordinated attention between the person with high cervical spinal cord injury and the helper. The constituents of the essence were: paralysis as a condition of life, facing the altered meal, reconciling with diminished bodily anchoring, sensitive cooperation between self and helper, realization of own values around meals, balanced use of meal-related devices and negotiating relationship with helpers. CONCLUSION: Assisted feeding should be adjusted to each individual person. Fixed procedures or routines should be avoided and assistive devices used with care. We recommend that continuity in the cooperation between the parties involved in assisted feeding is given priority, and that personal standard and social norms around meals are acknowledged. [ABSTRACT FROM AUTHOR]

Objective:To demonstrate the prospective construct validity of the walking index for spinal cord injury (WISCI) in US/European clinical population.Design:Prospective Cohort in Denmark, Germany, Italy and the USA.Participants/Method:Participants with acute complete/incomplete (ASIA Impairment Scale (AIS) A, B, C and D) traumatic spinal cord injuries were enrolled from four centers. Lower extremity motor scores (LEMS), WISCI level and Locomotor Functional Independence Measure (LFIM) levels were assessed with change in ambulatory status. WISCI progression was assessed for monotonic direction of improvement (MDI). LEMS were correlated to WISCI/LFIM. Use of walking aids/braces were analyzed.Results:One hundred and seventy participants were enrolled and 20 excluded. Of the 150 participants (USA 112/150; Europe 38/150) (AIS A=59, B=19, C=32, D=40), LEMS and WISCI assessments were performed initially and at final assessment (3–12 months post injury) or until maximum WISCI score of 20. Eighty-five percent of motor complete (66/78) and 10% (7/72) of motor incomplete participants showed no progression (73/150). Of the remaining participants (77/150) who improved, 81% (62/77) showed MDI. However, the deviation from MDI occurred only at one time-point in 10/15 participants. LEMS correlated with WISCI at initial and final assessment (0.47 and 0.91 P<0.001). Parallel bar use differed between the US and Europe possibly due to patterns of care. Use of braces also differed.Conclusion:The results support the hierarchical ranking of the WISCI scale and the correlation of WISCI levels to impairment (LEMS) in a clinical setting of four nations. Differences in practice between the US and Europe need consideration in design of trials.Spinal Cord (2008) 46, 181–188; doi:10.1038/sj.sc.3102071; published online 15 May 2007 [ABSTRACT FROM AUTHOR]

Background:A third version of the Spinal Cord Independence Measure (SCIM III), made up of three subscales, was formulated following comments by experts from several countries and Rasch analysis performed on the previous version.Objective:To examine the validity, reliability, and usefulness of SCIM III using Rasch analysis.Design:Multicenter cohort study.Setting:Thirteen spinal cord units in six countries from North America, Europe, and the Middle-East.Subjects:425 patients with spinal cord lesions (SCL).Interventions:SCIM III assessments by professional staff members. Rasch analysis of admission scores.Main outcome measures:SCIM III subscale match between the distribution of item difficulty grades and the patient ability measurements; reliability of patient ability measures; fit of data to Rasch model requirements; unidimensionality of each subscale; hierarchical ordering of categories within items; differential item functioning across classes of patients and across countries.Results:Results supported the compatibility of the SCIM subscales with the stringent Rasch requirements. Average infit mean-square indices were 0.79–1.06; statistically distinct strata of abilities were 3 to 4; most thresholds between adjacent categories were properly ordered; item hierarchy was stable across most of the clinical subgroups and across countries. In a few items, however, misfit or category threshold disordering were found.Conclusions:The scores of each SCIM III subscale appear as a reliable and useful quantitative representation of a specific construct of independence after SCL. This justifies the use of SCIM in clinical research, including cross-cultural trials. The results also suggest that there is merit in further refining the scale.Spinal Cord (2007) 45, 275–291. doi:10.1038/sj.sc.3101960; published online 15 August 2006 [ABSTRACT FROM AUTHOR]

Spinal cord injured (SCI) individuals have a substantial loss of bone mass in the lower limbs, equaling approximately 50% of normal values in the proximal tibia, and this has been associated with a high incidence of low impact fractures. To evaluate if this inactivity-associated condition in the SCI population can be reversed with prolonged physical training, ten SCI individuals [ages 35.3 +/- 2.3 years (mean +/- standard error [SE]); post injury time: 12.5 +/- 2.7 years, range 2-24 years; level of lesion: C6-Th4; weight: 78 +/- 3.8 kg] performed 12 months of Functional Electrical Stimulated (FES) upright cycling for 30 min per day, 3 days per week, followed by six months with only one weekly training session. Bone mineral density (BMD) was determined before training and 12 and 18 months later. BMD was measured in the lumbar spine, the femoral neck, and the proximal tibia by dual energy absorptiometry (DEXA, Nordland XR 26 MK1). Before training, BMD was in the proximal tibia (52%), as well as in the femoral neck, lower in SCI subjects than in controls of same age (P < 0.05). BMD of the lumbar spine did not differ between groups (P > 0.05). After 12 months of training, the BMD of the proximal tibia had increased 10%, from 0.49 +/- 0.04 to 0. 54 +/- 0.04 g/cm2 (P < 0.05). After a further 6 months with reduced training, the BMD in the proximal tibia no longer differed from the BMD before training (P > 0.05). No changes were observed in the lumbar spine or in the femoral neck in response to FES cycle training. It is concluded that in SCI, the loss of bone mass in the proximal tibia can be partially reversed by regular long-term FES cycle exercise. However, one exercise session per week is insufficient to maintain this increase. [ABSTRACT FROM AUTHOR]

Spinal cord injured (SCI) individuals most often contract their injury at a young age and are deemed to a life of more or less physical inactivity. In addition to the primary implications of the SCI, severe SCI individuals are stigmatized by conditions related to their physically inactive lifestyle. It is unknown if these inactivity related conditions are potentially reversible and the aim of the present study was, therefore, to examine the effect of exercise on SCI individuals. Ten such individuals (six with tetraplegia and four with paraplegia; age 27-45 years; time since injury 3-23 years) were exercise trained for 1 year using an electrically induced computerized feedback controlled cycle ergometer. They trained for up to three times a week (mean 2.3 times), 30 min on each occasion. The gluteal, hamstring and quadriceps muscles were stimulated via electrodes placed on the skin over their motor points. During the first training bouts, a substantial variation in performance was seen between the subjects. A majority of them were capable of performing 30 min of exercise in the first bout; however, two individuals were only able to perform a few minutes of exercise. After training for 1 year all of the subjects were able to perform 30 min of continuous training and the work output had increased from 4 +\- 1 (mean +\- SE) to 17 +\- 2 Kilo Joules per training bout (P < 0.05). The maximal oxygen uptake during electrically induced exercise increased from 1.20 +\- 0.08 litres per minute measured after a few weeks habituation to the exercise to 1.43 +\- 0.09 litres per minute after training for 1 year (P < 0.05). Magnetic resonance cross sectional images of the thigh were performed to estimate muscle mass and an increase of 12% (mean, P < 0.05) was seen in response to 1 year of training. In biopsies taken before exercise various degrees of atrophy were observed in the individual muscle fibres, a phenomenon that was partially normalized in all subjects after training. The fibre type distribution in skeletal muscles is known to shift towards type IIB fibres (fast twitch, fast fatiguable, glycolytic fibres) within the first 2 years after the spinal cord injury. The muscle in the present investigation contained of 63% myosin heavy chain (MHC) isoform IIB, 33% MHC isoform IIA (fast twitch, fatigue resistant) and less than 5% MHC isoform I (slow twitch) before training. A shift towards more fatigue resistant contractile proteins was found after 1 year of training. The percentage of MHC isoform IIA increased to 61% of all contractile protein and a corresponding decrease to 32% was seen in the fast fatiguable MHC isoform IIB, whereas MHC isoform I only comprised 7% of the total amount of MHC. This shift was accompanied by a doubling of the enzymatic activity of citrate synthase, as an indicator of mitochondrial oxidative capacity. It is concluded that inactivity-associated changes in exercise performance capacity and skeletal muscle occurring in SCI individuals after injury are reversible, even up to over 20 years after the injury. It follows that electrically induced exercise training of the paralysed limbs is an effective rehabilitation tool that should be offered to SCI individuals in the future. [ABSTRACT FROM AUTHOR]

Context: The Spinal Cord Independence Measure is a comprehensive functional rating scale for individuals with spinal cord lesion (SCL)., Objective: To validate the scores of the three subscales of SCIM IV, the fourth version of SCIM, using advanced statistical methods., Study Design: Multi-center cohort study., Setting: Nineteen SCL units in 11 countries., Methods: SCIM developers created SCIM IV following comments by experts, included more accurate definitions of scoring criteria in the SCIM IV form, and adjusted it to assess specific conditions or situations that the third version, SCIM III, does not address. Professional staff members assessed 648 SCL inpatients, using SCIM IV and SCIM III, at admission to rehabilitation, and at discharge. The authors examined the validity and reliability of SCIM IV subscale scores using Rasch analysis., Results: The study included inpatients aged 16-87 years old. SCIM IV subscale scores fit the Rasch model. All item infit and most item outfit mean-square indices were below 1.4; statistically distinct strata of abilities were 2.6-6; most categories were properly ordered; item hierarchy was stable across most clinical subgroups and countries. In a few items, however, we found misfit or category threshold disordering. We found SCIM III and SCIM IV Rasch properties to be comparable., Conclusions: Rasch analysis suggests that the scores of each SCIM IV subscale are reliable and valid. This reinforces the justification for using SCIM IV in clinical practice and research.

Objective: To examine the fourth version of the Spinal Cord Independence Measure for reliability and validity., Design: Partly blinded comparison with the criterion standard Spinal Cord Independence Measure III, and between examiners and examinations., Setting: A multicultural cohort from 19 spinal cord injury units in 11 countries., Participants: A total of 648 patients with spinal cord injury., Intervention: Assessment with Spinal Cord Independence Measure (SCIM IV) and Spinal Cord Independence Measure (SCIM III) on admission to inpatient rehabilitation and before discharge., Main Outcome Measures: SCIM IV interrater reliability, internal consistency, correlation with and difference from SCIM III, and responsiveness., Results: Total agreement between examiners was above 80% on most SCIM IV tasks. All Kappa coefficients were above 0.70 and statistically significant (P<.001). Pearson's coefficients of the correlation between the examiners were above 0.90, and intraclass correlation coefficients were above 0.90. Cronbach's alpha was above 0.96 for the entire SCIM IV, above 0.66 for the subscales, and usually decreased when an item was eliminated. Reliability values were lower for the subscale of respiration and sphincter management, and on admission than at discharge. SCIM IV and SCIM III mean values were very close, and the coefficients of Pearson correlation between them were 0.91-0.96 (P<.001). The responsiveness of SCIM IV was not significantly different from that of SCIM III in most of the comparisons., Conclusions: The validity, reliability, and responsiveness of SCIM IV, which was adjusted to assess specific patient conditions or situations that SCIM III does not address, and which includes more accurate definitions of certain scoring criteria, are very good and quite similar to those of SCIM III. SCIM IV can be used for clinical and research trials, including international multi-center studies, and its group scores can be compared with those of SCIM III., (Copyright © 2021 The American Congress of Rehabilitation Medicine. All rights reserved.)

Design: Descriptive., Setting: Community, Bangladesh., Objectives: To determine the costs associated with providing a community-based model of care delivered as part of the CIVIC trial to people discharged from hospital with recent spinal cord injury (SCI), and to determine the economic burden to households., Methods: Records were kept of the costs of providing a community-based model of care to participants of the CIVIC trial. Data were also collected at discharge and 2 years post discharge to capture out-of-pocket healthcare costs over the preceding 2 years, and the number of participants suffering catastrophic health expenditure and illness-induced poverty., Results: The mean cost of providing the community-based model of care to participants assigned to the intervention group (n = 204) was US$237 per participant. The mean out-of-pocket healthcare cost over the first 2 years post discharge was US$472 per participant (n = 410), and US$448 per control participant (n = 206). Median (IQR) equivalent annual household incomes prior to SCI and at 2 years post discharge were US$721 (US$452-1129) and US$464 (US$214-799), respectively. Of the 378 participants alive at 2 years, 324 (86%) had catastrophic health expenditure, and 161 of 212 participants who were not in poverty prior to injury (76%) were pushed into illness-induced poverty within 2 years of injury., Conclusion: The cost of providing community-based support to people with SCI for 2 years post discharge in Bangladesh is relatively inexpensive but an overwhelming majority of households rapidly experience financial catastrophe, and most fall into poverty., (© 2021. The Author(s), under exclusive licence to International Spinal Cord Society.)

Study Design: Randomised controlled trial., Objectives: To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh., Setting: Bangladesh., Methods: A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation., Results: Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications., Conclusion: A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.

Design: Mixed methods study SETTING: Community, Bangladesh OBJECTIVES: To understand how a community-based intervention for people with spinal cord injury (SCI) in Bangladesh was delivered as part of a randomised controlled trial and to gauge the perceptions of participants and healthcare professionals to the intervention., Methods: A community-based intervention was administered to 204 participants as part of a large randomised controlled trial (called the CIVIC trial). Case-managers followed-up participants with regular telephone calls and home visits over the first 2 years after discharge. The following data were collected alongside the trial: (i) chart audit of telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers., Results: Participants received the target number of telephone calls and home visits. Pressure injuries were identified as a problem during at least one telephone call by 43% of participants. Participants and case-managers valued regular telephone calls and home visits, and believed that calls and visits prevented complications and alleviated social isolation. Participants trusted case-managers and were confident in the care and advice provided. Case-managers expressed concerns that people with SCI in Bangladesh face many problems impacting on well-being and motivation stemming from poverty, limited employment opportunities, societal attitudes and inaccessible environments., Conclusion: A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care. Nonetheless, people with SCI in Bangladesh face economic and social problems which cannot be fully addressed by this type of intervention alone.

Objective: To provide an overview of clinical assessments and diagnostic tools, self-report measures (SRMs) and data sets used in neurogenic bladder and bowel (NBB) dysfunction and recommendations for their use with persons with spinal cord injury /disease (SCI/D). Methods: Experts in SCI/D conducted literature reviews, compiled a list of NBB related assessments and measures, reviewed their psychometric properties, discussed their use in SCI/D and issued recommendations for the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) guidelines. Results: Clinical assessments included 15 objective tests and diagnostic tools for neurogenic bladder and 12 for neurogenic bowel. Following a two-phase evaluation, eight SRMs were selected for final review with the Qualiveen and Short-Form (SF) Qualiveen and the Neurogenic Bowel Dysfunction Score (NBDS) being recommended as supplemental, highly-recommended due to their strong psychometrics and extensive use in SCI/D. Two datasets and other SRM measures were recommended as supplemental. Conclusion: There is no one single measure that can be used to assess NBB dysfunction across all clinical research studies. Clinical and diagnostic tools are here recommended based on specific medical needs of the person with SCI/D. Following the CDE for SCI studies guidelines, we recommend both the SF-Qualiveen for bladder and the NBDS for bowel as relatively short measures with strong psychometrics. Other measures are also recommended. A combination of assessment tools (objective and subjective) to be used jointly across the spectrum of care seems critical to best capture changes related to NBB and develop better treatments.

Objectives: To (1) compare energy expenditure during seated rest, standing, and prolonged bionic ambulation or bipedal ambulation in participants with spinal cord injury (SCI) and noninjured controls, respectively, and (2) test effects on postbionic ambulation glycemia in SCI., Design: Two independent group comparison of SCI and controls., Setting: Academic Medical Center., Participants: Ten participants with chronic SCI (C7-T1, American Spinal Injury Association Impairment Scale A-C) and 10 controls (N=20)., Interventions: A commercial bionic exoskeleton., Main Outcome Measures: Absolute and relative (to peak) oxygen consumption, perceived exertion, carbohydrate/fat oxidation, energy expenditure, and postbionic ambulation plasma glucose/insulin., Results: Average work intensity accompanying 45 minutes of outdoor bionic ambulation was <40% peak oxygen consumption, with negligible drift after reaching steady state. Rating of perceived exertion (RPE) did not differ between groups and reflected low exertion. Absolute energy costs for bionic ambulation and nonbionic ambulation were not different between groups despite a 565% higher ambulation velocity in controls and 3.3× higher kilocalorie per meter in SCI. Fuel partitioning was similar between groups and the same within groups for carbohydrate and fat oxidation. Nonsignificant (9%) lowering of the area under a glucose tolerance curve following bionic ambulation required 20% less insulin than at rest., Conclusion: Work intensity during prolonged bionic ambulation for this bionic exoskeleton is below a threshold for cardiorespiratory conditioning but above seated rest and passive standing. Bionic ambulation metabolism is consistent with low RPE and unchanged fuel partitioning from seated rest. Bionic ambulation did not promote beneficial effects on glycemia in well-conditioned, euglycemic participants. These findings may differ in less fit individuals with SCI or those with impaired glucose tolerance. Observed trends favoring this benefit suggest they are worthy of testing., (Published by Elsevier Inc.)

Introduction: Spinal cord injury (SCI) predisposes those who suffer from it to physical inactivity and weight gain; consequently, death due to cardiovascular diseases is more frequent among people with SCI than in the general population. The literature documents a consensus about an interdisciplinary multimodal approach for the prevention and treatment of cardiovascular risk factors including overweight and obesity in people with SCI, focusing on diet, physical activity (PA) and behavioural interventions. This study will investigate implementation of recommendations from a recent clinical practice guideline for identification and management of cardiometabolic risk after SCI through multimodal patient education in a subacute clinical setting., Methods and Analysis: All patients who are aged 18 years or older with an SCI within the previous 12 months and admitted to highly specialised rehabilitation are included, regardless of SCI aetiology or neurological level. A primary study designed as a controlled, pragmatic, preintervention- postintervention study with 6-month follow-up evaluates the effect of the clinical intervention; a prospective national cohort study on body mass index (BMI) serves as a historical control. The intervention consists of a standardised approach to patient education about cardiovascular risk factors, PA and a healthy diet that begins at the outset of primary SCI rehabilitation and is integrated into existing settings and workflows. Outcome measures are collected at admission, discharge and 6 months after discharge and include peak oxygen uptake (VO2peak) (primary outcome), BMI, body composition, metabolic profile, neurological status, level of functioning, depression, quality of life, objective PA (accelerometry), self-reported PA, self-assessed PA ability, shared decision making, and dietary habits. Test-retest reliability of four VO2peak test protocols are investigated, as is test-retest reliability of a multisensor accelerometer in a rehabilitation setting., Ethics and Dissemination: The project is approved by the Committees on Health Research Ethics in the Capital Region of Denmark on 10 July 2018 (Journal-nr.: H-18018325). The principal investigator obtains informed consent from all participants. The interventions in the project are closely related to existing rehabilitation care, and the risk of pain and discomfort is considered modest. Any unintended events related to the elements of the intervention are reported, according to existing regional procedures. Data are stored in a secure web-based database (Redcap). The primary study and prospective cohort study are registered at Clinicaltrials.gov. Positive and negative results will be submitted to relevant scientific journals related to SCI for publication. Important protocol modifications are reported to the Committees on Health Research Ethics in the Capital Region of Denmark., Trial Registration Numbers: NCT03689023 and NCT03369080., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)