Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.
- Conditions
- Stroke, AcuteStrokeCerebrovascular AccidentCerebrovascular Accident, Acute
- Interventions
- Procedure: Standard physical therapyDevice: Ekso gait training
- Registration Number
- NCT05241457
- Lead Sponsor
- Sunnyview Rehabilitation Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Inpatient at Sunnyview Rehabilitation Hospital
- Right or left hemispheric stroke
- >18 years of age
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard of care group Standard physical therapy 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. Ekso exoskeleton gait training group Ekso gait training 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. Ekso exoskeleton gait training group Standard physical therapy 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.
- Primary Outcome Measures
Name Time Method 10-meter walk test at self-selected speed (10MWT, SSS) T3 (Day 27-29) Used to assess walking speed over a short distance at the patient's chosen speed.
BERG Balance scale T3 (Day 27-29) 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.
10-meter walk test at fast speed (10MWT, fast) T3 (Day 27-29) Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.
6-minute walk test (6MWT) T3 (Day 27-29) Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.
- Secondary Outcome Measures
Name Time Method Intrinsic Motivation Inventory (IMI) T2 (Day 20-22) The value of the intervention as perceived by patients
Functional Ambulation Category (FAC) T3 (Day 27-29) A five-point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Trial Locations
- Locations (1)
Sunnyview
🇺🇸Schenectady, New York, United States