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

April 3, 2026 updated by: Karah Lenge, Sunnyview Rehabilitation Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Schenectady, New York, United States, 12308
        • Sunnyview

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Inpatient Rehabilitation Facility

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Standard physical therapy
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).
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.
Procedure: Standard physical therapy
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).
Device: Ekso gait training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
T1 (Day 14-16)
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.
T2 (Day 20-22)
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.
T3 (Day 27-29)
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.
T1 (Day 14-16)
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.
T2 (Day 20-22)
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.
T3 (Day 27-29)
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.
T1 (Day 14-16)
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.
T2 (Day 20-22)
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.
T3 (Day 27-29)
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.
T1 (Day 14-16)
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.
T2 (Day 20-22)
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.
T3 (Day 27-29)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulation Category (FAC)
Time Frame: T1 (Day 14-16)
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)
Time Frame: T2 (Day 20-22)
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)
Time Frame: 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.
T3 (Day 27-29)
Intrinsic Motivation Inventory (IMI)
Time Frame: T2 (Day 20-22)
The value of the intervention as perceived by patients
T2 (Day 20-22)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnyview Rehabilitation Hospital

Investigators

  • Principal Investigator: Karah Lenge, DPT, Sunnyview Rehabilitation Hospital
  • Principal Investigator: Allison Tallon, DPT, Sunnyview Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Actual)

March 11, 2026

Study Completion (Actual)

March 11, 2026

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1116-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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