Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial.

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 (< 3 months) who were unable to walk without substantial assistance (Functional Ambulation Category rating of 0 or 1) were randomly assigned to receive exoskeleton-based or standard physical therapy during rehabilitation, until discharge or a maximum of 8 weeks. The experimental protocol replaced 75% of standard physical therapy sessions with individualized exoskeleton-based sessions to increase standing and stepping repetition, with the possibility of weaning off the device. The primary outcome was walking ability, measured using the Functional Ambulation Category. Secondary outcomes were gait speed, distance walked on the 6-Minute Walk Test, days to achieve unassisted gait, lower extremity motor function (Fugl-Meyer Assessment), Berg Balance Scale, Patient Health Questionnaire, Montreal Cognitive Assessment, and 36-Item Short Form Survey, measured post-intervention and after 6 months. 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).

Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation.

BACKGROUND: The ability to walk is commonly reported as a top rehabilitation priority for individuals after a stroke. However, not all individuals with stroke are able to practice walking, especially those who require more assistance from their therapist to do so. Powered robotic exoskeletons are a new generation of robotic-assisted gait training devices, designed to assist lower extremity movement to allow repetitious overground walking practice. To date, minimal research has been conducted on the use of an exoskeleton for gait rehabilitation after stroke. The following research protocol aims to evaluate the efficacy and acceptability, and thus adoptability, of an exoskeleton-based gait rehabilitation program for individuals with stroke. METHODS: This research protocol describes a prospective, multi-center, mixed-methods study comprised of a randomized controlled trial and a nested qualitative study. Forty adults with subacute stroke will be recruited from three inpatient rehabilitation hospitals and randomized to receive either the exoskeleton-based gait rehabilitation program or usual physical therapy care. The primary outcome measure is the Functional Ambulation Category at post-intervention, and secondary outcomes include motor recovery, functional mobility, cognitive, and quality-of-life measures. Outcome data will be collected at baseline, post-intervention, and at 6 months. The qualitative component will explore the experience and acceptability of using a powered robotic exoskeleton for stroke rehabilitation from the point of view of individuals with stroke and physical therapists. Semi-structured interviews will be conducted with participants who receive the exoskeleton intervention, and with the therapists who provide the intervention. Qualitative data will be analyzed using interpretive description. DISCUSSION: This study will be the first mixed-methods study examining the adoptability of exoskeleton-based rehabilitation for individuals with stroke. It will provide valuable information regarding the efficacy of exoskeleton-based training for walking recovery and will shed light on how physical therapists and patients with stroke perceive the device. The findings will help guide the integration of robotic exoskeletons into clinical practice. TRIAL REGISTRATION: NCT02995265 (clinicaltrials.gov), Registered 16 December 2016.

Patients' and therapists' experience and perception of exoskeleton-based physiotherapy during subacute stroke rehabilitation: a qualitative analysis.

PURPOSE: To explore the experience and acceptability of an exoskeleton-based physiotherapy program for non-ambulatory patients during subacute stroke rehabilitation from the perspective of patients and therapists. MATERIALS AND METHODS: This was a qualitative descriptive study using semi-structured interviews and thematic analysis. Fourteen patients with stroke who participated in the experimental arm of a randomized controlled trial investigating the efficacy of exoskeleton-based physiotherapy were recruited. Six physiotherapists who provided the intervention were also recruited. RESULTS: Three themes were identified relating to the experience and acceptability of an exoskeleton-based physiotherapy program: (1) A matter of getting into the swing of things depicted the initial and ongoing learning process of using an exoskeleton; (2) More of a positive experience than anything else described the participants' mostly favorable attitude toward exoskeleton-based gait training; and (3) The best step forward captured participant-identified recommendations and considerations for the future integration of exoskeleton training into stroke rehabilitation. CONCLUSIONS: Patients with stroke were even more optimistic than therapists toward the experience and benefits of exoskeleton-based gait training during subacute stroke rehabilitation. Future clinical practice should consider the balance between actual and perceived benefits, as well as the potential barriers to integrating an exoskeleton into stroke rehabilitation.IMPLICATIONS FOR REHABILITATIONPowered robotic exoskeletons can be used to provide higher duration and more repetitious walking practice for non-ambulatory patients with stroke.Patients with stroke view exoskeleton-based physiotherapy highly favorably, attributing greater opportunity and benefit to using the device during subacute rehabilitation.Physiotherapists should consider learning challenges, patient characteristics, and implementation barriers when integrating exoskeleton-based training within a treatment program.