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

Sunnyview Rehabilitation Hospital

Status: Enrolling

Conditions: Cerebrovascular Accident; Stroke; Stroke, Acute; Cerebrovascular Accident, Acute

Treatments: Device: Ekso gait training; Procedure: Standard physical therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05241457

21-1116-1

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Standard of care group

Description:

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.

Treatment:

Procedure: Standard physical therapy

Ekso exoskeleton gait training group

Description:

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.

Treatment:

Procedure: Standard physical therapy

Device: Ekso gait training