Effectiveness of the Mobility Rehab System for Mobility Training in Older Adults: A Pragmatic Clinical Trial.

Introduction: Mobility impairments are among the main causes of falls in older adults and patients with neurological diseases, leading to functional dependence and substantial health care costs. Feedback-based interventions applied in controlled, laboratory environments have shown promising results for mobility rehabilitation, enhancing the benefits of standard therapy. However, the effectiveness of sensor-based feedback to improve gait in actual outpatient physical therapy settings is unknown. The proposed trial examines the effectiveness of a physical therapist-assisted, visual feedback system using wearable inertial sensors, Mobility Rehab, for mobility training in older adults with gait disturbances in an outpatient clinic. Methods: The study is a single site, pragmatic clinical trial in older adults with gait disturbances. Two hundred patients undergoing their outpatient rehabilitation program are assigned, by an independent assistant, for screening by one of four therapists, and assigned to either a standard physical therapy or therapist-assisted feedback therapy. Both groups train twice a week for 6 weeks. Four physical therapists were randomized and stratified by years of experience to deliver standard therapy or therapist-assisted feedback rehabilitation. Each session is 45 min long. Gait is trained for 30 min. The additional 15 min include exercises for endurance, strength, and static and dynamic balance in functional tasks. Mobility Rehab uses unobtrusive, inertial sensors on the feet and belt with real-time algorithms to provide real-time feedback on gait metrics (i.e., gait speed, double support time, foot clearance, angle at foot strike, and arm swing), which are displayed on a hand-held monitor. Blinded assessments are carried out before and after the intervention. The primary outcome measure is subjects' perception of balance as measured by the Activities-specific Balance Confidence scale. Gait speed, as measured with wearable inertial sensors during walking, is the secondary outcome measure. Discussion: We hypothesize that therapist-assisted feedback rehabilitation will be more effective than standard rehabilitation for gait. Feedback of motor performance plays a crucial role in rehabilitation and objective characterization of gait impairments by Mobility Rehab has the potential to improve the accuracy of patient-specific gait feedback. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03869879.
Competing Interests: FBH and ME-G are employees of APDM Wearable Technologies-an ERT company, a company that may have a commercial interest in the results of this research and technology. This potential conflict has been reviewed and managed by OHSU. In addition, SP was employed by APDM Wearable Technologies-an ERT company. FBH also consults with Autobahn, Biogen, Pfizer, Medtronic, Neuropore, Sanofi, and Takeda. The remaining authors declare that the research was conducted in absence of any commercial or financial relationship that could be construed as a potential conflict of interest.
(Copyright © 2021 Vitório, El-Gohary, Pearson, Carlson-Kuhta, Harker, Horak, Lapidus, Studer and Mancini.)