TerminatedNot Applicable

Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training

Stopped: Lack of participants

United States3 participantsStarted 2024-10-01

Plain-language summary

The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older * English or Spanish-speaking * A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke) * Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic Exclusion Criteria: * Unable to follow 1-step commands * \> 220 pounds (100 kg) * Height \< 5'0" or \> 6'4" * Unable to take a few steps with assistance * A score of ≥ 50/56 on Berg Balance Scale (BBS) * A score of ≥ 26/30 on Functional Gait Assessment (FGA) * Resting blood pressure \>180/110 mmHg * Resting heart rate \> 120 bpm * Severe cardiac disease (New York Heart Association Classification IV) * Severe spasticity (Modified Ashworth score \> 3) * Unstable spine or unhealed pelvic/limb fractures * Active heterotrophic ossification impacting lower extremity range of motion * Significant lower or upper extremity contractures * Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion * Pregnancy * Colostomy * Poor skin integrity in areas in contact with the EksoGTTM * Unresolved deep vein thrombosis * Lower limb prosthesis or amputation * Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs * ROM restrictions preventing normal, reciprocal gait * Inability to stand for \> 3 minutes due to pain or orthostatic hypotension * Pusher syndrome * Cortical blindness

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demographic Questionnaire

Timeframe: Pre-intervention

Newest Vital Sign (NVS)

Timeframe: Pre-intervention

Multidimensional Scale of Perceived Social Support (MSPSS)

Timeframe: Pre-intervention

Patient Health Questionnaire (PHQ-9)

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

3-Meter Backwards Walk Test (3MBWT)

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

6-Minute Walk Test

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

10-meter Walk Test

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

Trial details

NCT IDNCT06478680

SponsorAlvernia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Demographic Questionnaire

Timeframe: Pre-intervention

Newest Vital Sign (NVS)

Timeframe: Pre-intervention

Multidimensional Scale of Perceived Social Support (MSPSS)

Timeframe: Pre-intervention

Patient Health Questionnaire (PHQ-9)

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

3-Meter Backwards Walk Test (3MBWT)

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

6-Minute Walk Test

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

10-meter Walk Test

Timeframe: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)