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NCT Number: NCT05241457

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnyview

Schenectady, New York, 12308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ekso gait training

Device

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.

Standard physical therapy

Procedure

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Intrinsic Motivation Inventory (IMI)

    Time frame: T2 (Day 20-22)

    The value of the intervention as perceived by patients

Sponsors and collaborators

Lead sponsor

Sunnyview Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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