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Robotics

Robotic Gait Training for Stroke (ERA Stroke Trial)

N/A
Recruiting
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All types of stroke
Continence or on a program for bladder and bowel management
Must not have
Profound cognitive impairment
Concurrent neurological diagnoses (e.g., TBI, degenerative, CNS neoplasm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 3.5 months)
Awards & highlights

Summary

This trial will compare the benefits of using a robotic device for walking therapy versus standard care in stroke patients undergoing rehabilitation at Baylor Scott & White Institute for Rehabilitation.

Who is the study for?
This trial is for stroke patients aged 18-85 in the early recovery phase who have the potential to regain walking ability. Participants must be medically stable, able to fit into a robotic exoskeleton, and managing continence. It excludes those with severe cognitive issues, pregnancy, or other neurological conditions like TBI.
What is being tested?
The study compares two types of gait training: Robotic Gait Training (RGT) using an exoskeleton and Usual Care (UC) methods during inpatient rehab at BSWIR. The goal is to see which method better aids patients recovering from different types of strokes.
What are the potential side effects?
While specific side effects are not listed for this type of physical therapy intervention, participants may experience fatigue, discomfort or skin irritation related to the use of the robotic device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a stroke.
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I can control my bladder and bowel or am following a management program.
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I am between 18 and 85 years old.
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I fit within the size and weight limits for the Ekso robotic exoskeleton.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant difficulties with thinking or memory.
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I have a brain-related condition like TBI or a brain tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 3.5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 3.5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gait speed via 10-Meter Walk Test (10MWT)
Secondary outcome measures
5 Times Sit-to-Stand Test (5TSST)
6-Minute Walk Test (6MWT)
Berg Balance Scale (BBS)
+8 more
Other outcome measures
Adverse event rate
Gait quality
Pain following each gait training session
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Robotic Gait TrainingExperimental Treatment1 Intervention
Participants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.
Group II: Usual Care Gait TrainingActive Control1 Intervention
Participants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.

Find a Location

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
77 Previous Clinical Trials
9,597 Total Patients Enrolled
7 Trials studying Stroke
2,377 Patients Enrolled for Stroke
Baylor Research InstituteLead Sponsor
205 Previous Clinical Trials
203,361 Total Patients Enrolled
7 Trials studying Stroke
349 Patients Enrolled for Stroke
~36 spots leftby Jun 2026
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