Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.

Study Overview
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Brief Summary
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The Ekso (Ekso Bionics) is a wearable exoskeleton that provides robotic support and walking assistance for patients with lower extremity paralysis. Research suggests that exoskeleton-assisted gait training is as effective as conventional gait training at improving walking outcomes and balance during both the chronic and subacute period following stroke (Goffredo et al., 2019; Molteni et al., 2017; Molteni et al., 2021; Nam et al., 2019; Rojek, 2019). Exoskeleton-assisted gait training during acute inpatient rehabilitation provides a means for patients to actively participate in gait training during the early and most severe stages of stroke recovery. Most acute inpatient rehabilitation facilities (IRFs) report a feasibility of 5-8 Ekso sessions during inpatient stays and demonstrate significant improvement from baseline (Nolan et al., 2020; Swank, 2020). Nolan et al. (2020) demonstrated that stroke patients receiving Ekso ambulated 1640 feet more than patients undergoing more conventional gait training techniques during inpatient rehabilitation, suggesting that the exoskeleton may offer additional benefit during this phase of recovery. Despite promising evidence, there have been no randomized controlled trials within the IRF setting. Because Ekso-gait training increases the number of steps patients can take, during acute inpatient physical therapy (PT), the investigators hypothesize that patients who participate in Ekso-gait training will demonstrate quicker improvements in balance, gait speed, endurance and independence in functional ambulation during their stay in the IRF. In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or Ekso-gait training therapy. Meaningful clinical benchmarks for balance and walking will be assessed using the Berg Balance Scale (BBS) (Alghadir, 2018; Moore, 2018), the 10 Meter Walk Test (10MWT) (Bowden, 2008; Moore, 2018), the Six Minute Walk Test (6MWT) (Kubo et al., 2020; Moore, 2018), and Functional Ambulation Category (FAC) (Mehrholz, 2007). Achieving these benchmark scores are associated with several positive outcomes, including increased ability to ambulate in the community and reduced risk of falling (Alghadir, 2018; Bowden, 2008; Kubo et al., 2020). The investigators also hypothesize that patients in the Ekso cohort will report greater value/usefulness when compared to patients receiving standard care.

Official Title
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Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.

Conditions
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Stroke, Stroke, Acute, Cerebrovascular Accident, Cerebrovascular Accident, Acute

Intervention / Treatment
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* Device: Ekso gait training
* Procedure: Standard physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient at Sunnyview Rehabilitation Hospital Right or left hemispheric stroke >18 years of age Exclusion Criteria: No paresis Paraplegia Quadriplegia FAC of 2,3 or 4 Weight > 220 lbs (Ekso manufacturer criteria) Height > 6'4 (Ekso manufacturer criteria) > 3 months post stroke onset Comorbidities affecting gait (LE fractures, Parkinson's, Severe Polyneuropathy) LE/sacral wounds that come into contact with the Ekso LE contractures that cannot be accommodated by Ekso Prior Stroke Weight Bearing Restrictions 8 Unable to follow 1-2 step commands. Contact precautions for COVID-19

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care group<br>Patients will receive the standard physical therapy sessions that they would normally receive during their IRF stay, (60 to 90 min sessions, 5 to 6 days/week). This group will not receive Ekso exoskeleton gait training. | Procedure: Standard physical therapy<br>* Standard physical therapy sessions will be 60 to 90 minutes a day. Clinicians typically focus on gait, balance, and strengthening activities that address goals related to functional mobility. Other devices that would normally be used during PT sessions, including the Lite Gait and Rifton tram body weight support devices and electrical stimulation devices including the XCITE and RT300 (from Restorative Therapies).<br>|
| Ekso exoskeleton gait training group<br>Patients in the Ekso group will have several (2 to 3) of their standard of care sessions replaced with Ekso gait training sessions each week. | Device: Ekso gait training<br>* Ekso sessions will be 60 minutes each. Patients will be measured to optimize Ekso fit during their initial training session. Ekso settings will be progressed as deemed appropriate by the trained clinician. The progression of Ekso settings allows the patient to use their maximum effort while the Ekso assists only as much as the patient requires to complete stepping. Patients may also spend time working on pre-gait activities and balance activities including weight shifting, stepping in place, side-stepping and backwards ambulation based on the patient's needs as determined by the clinician.<br>Procedure: Standard physical therapy<br>* Standard physical therapy sessions will be 60 to 90 minutes a day. Clinicians typically focus on gait, balance, and strengthening activities that address goals related to functional mobility. Other devices that would normally be used during PT sessions, including the Lite Gait and Rifton tram body weight support devices and electrical stimulation devices including the XCITE and RT300 (from Restorative Therapies).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter walk test at self-selected speed (10MWT, SSS) | Used to assess walking speed over a short distance at the patient's chosen speed. | T1 (Day 14-16) | 
| 10-meter walk test at self-selected speed (10MWT, SSS) | Used to assess walking speed over a short distance at the patient's chosen speed. | T2 (Day 20-22) | 
| 10-meter walk test at self-selected speed (10MWT, SSS) | Used to assess walking speed over a short distance at the patient's chosen speed. | T3 (Day 27-29) | 
| 10-meter walk test at fast speed (10MWT, fast) | Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk. | T1 (Day 14-16) | 
| 10-meter walk test at fast speed (10MWT, fast) | Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk. | T2 (Day 20-22) | 
| 10-meter walk test at fast speed (10MWT, fast) | Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk. | T3 (Day 27-29) | 
| BERG Balance scale | A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements. | T1 (Day 14-16) | 
| BERG Balance scale | A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements. | T2 (Day 20-22) | 
| BERG Balance scale | A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements. | T3 (Day 27-29) | 
| 6-minute walk test (6MWT) | Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded. | T1 (Day 14-16) | 
| 6-minute walk test (6MWT) | Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded. | T2 (Day 20-22) | 
| 6-minute walk test (6MWT) | Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded. | T3 (Day 27-29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulation Category (FAC) | A five-point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking. | T1 (Day 14-16) | 
| Functional Ambulation Category (FAC) | A five-point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking. | T2 (Day 20-22) | 
| Functional Ambulation Category (FAC) | A five-point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking. | T3 (Day 27-29) | 
| Intrinsic Motivation Inventory (IMI) | The value of the intervention as perceived by patients | T2 (Day 20-22) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeleton, Gait training, Inpatient rehabilitation, Ekso gait training