1. Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial
- Author
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Melanie Durocher, Jennifer Yao, Amy Schneeberg, Janice J. Eng, Dennis R. Louie, W. Ben Mortenson, and Robert Teasell
- Subjects
030506 rehabilitation ,medicine.medical_specialty ,medicine.medical_treatment ,Health Informatics ,Neurosciences. Biological psychiatry. Neuropsychiatry ,Walking ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Gait training ,law ,Humans ,Medicine ,Stroke ,Gait Disorders, Neurologic ,Physical Therapy Modalities ,Physical therapy techniques ,Rehabilitation ,business.industry ,Research ,Stroke Rehabilitation ,Exoskeleton Device ,medicine.disease ,Gait ,Exercise Therapy ,Exoskeleton ,Clinical trial ,Treatment Outcome ,Berg Balance Scale ,Physical therapy ,0305 other medical science ,business ,human activities ,030217 neurology & neurosurgery ,RC321-571 - Abstract
Background Individuals requiring greater physical assistance to practice walking complete fewer steps in physical therapy during subacute stroke rehabilitation. Powered exoskeletons have been developed to allow repetitious overground gait training for individuals with lower limb weakness. The objective of this study was to determine the efficacy of exoskeleton-based physical therapy training during subacute rehabilitation for walking recovery in non-ambulatory patients with stroke. Methods An assessor-blinded randomized controlled trial was conducted at 3 inpatient rehabilitation hospitals. Patients with subacute stroke ( Results Thirty-six patients with stroke (mean 39 days post-stroke) were randomized (Exoskeleton = 19, Usual Care = 17). On intention-to-treat analysis, no significant between-group differences were found in the primary or secondary outcomes at post-intervention or after 6 months. Five participants randomized to the Exoskeleton group did not receive the protocol as planned and thus exploratory as-treated and per-protocol analyses were undertaken. The as-treated analysis found that those adhering to exoskeleton-based physical therapy regained independent walking earlier (p = 0.03) and had greater gait speed (p = 0.04) and 6MWT (p = 0.03) at 6 months; however, these differences were not significant in the per-protocol analysis. No serious adverse events were reported. Conclusions This study found that exoskeleton-based physical therapy does not result in greater improvements in walking independence than standard care but can be safely administered at no detriment to patient outcomes. Clinical Trial Registration The Exoskeleton for post-Stroke Recovery of Ambulation (ExStRA) trial was registered at ClinicalTrials.gov (NCT02995265, first registered: December 16, 2016)
- Published
- 2021