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Clinical Trials/NCT05241457
NCT05241457
Completed
Not Applicable

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

Sunnyview Rehabilitation Hospital2 sites in 1 country40 target enrollmentMarch 11, 2022

Overview

Phase
Not Applicable
Intervention
Standard physical therapy
Conditions
Stroke
Sponsor
Sunnyview Rehabilitation Hospital
Enrollment
40
Locations
2
Primary Endpoint
10-meter walk test at self-selected speed (10MWT, SSS)
Status
Completed
Last Updated
23 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 11, 2022
End Date
March 11, 2026
Last Updated
23 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karah Lenge

Doctor of Physical Therapy

Sunnyview Rehabilitation Hospital

Eligibility Criteria

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

Arms & Interventions

Standard of care group

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.

Intervention: Standard physical therapy

Ekso exoskeleton gait training group

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.

Intervention: Ekso gait training

Ekso exoskeleton gait training group

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.

Intervention: Standard physical therapy

Outcomes

Primary Outcomes

10-meter walk test at self-selected speed (10MWT, SSS)

Time Frame: T3 (Day 27-29)

Used to assess walking speed over a short distance at the patient's chosen speed.

BERG Balance scale

Time Frame: 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)

Time Frame: 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)

Time Frame: T3 (Day 27-29)

Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.

10-meter walk test at self-selected speed (10MWT, SSS)

Time Frame: T1 (Day 14-16)

Used to assess walking speed over a short distance at the patient's chosen speed.

10-meter walk test at self-selected speed (10MWT, SSS)

Time Frame: T2 (Day 20-22)

Used to assess walking speed over a short distance at the patient's chosen speed.

10-meter walk test at fast speed (10MWT, fast)

Time Frame: T1 (Day 14-16)

Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.

10-meter walk test at fast speed (10MWT, fast)

Time Frame: T2 (Day 20-22)

Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.

BERG Balance scale

Time Frame: T1 (Day 14-16)

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.

BERG Balance scale

Time Frame: T2 (Day 20-22)

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.

6-minute walk test (6MWT)

Time Frame: T1 (Day 14-16)

Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.

6-minute walk test (6MWT)

Time Frame: T2 (Day 20-22)

Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.

Secondary Outcomes

  • Intrinsic Motivation Inventory (IMI)(T2 (Day 20-22))
  • Functional Ambulation Category (FAC)(T3 (Day 27-29))
  • Functional Ambulation Category (FAC)(T1 (Day 14-16))
  • Functional Ambulation Category (FAC)(T2 (Day 20-22))

Study Sites (2)

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