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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
No Placebo-Only Group
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 belowSelect...
I have had a stroke.
Select...
I can control my bladder and bowel or am following a management program.
Select...
I am between 18 and 85 years old.
Select...
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:Select...
I have significant difficulties with thinking or memory.
Select...
I have a brain-related condition like TBI or a brain tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (up to 3.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 3.5 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gait speed via 10-Meter Walk Test (10MWT)
Secondary study objectives
5 Times Sit-to-Stand Test (5TSST)
6-Minute Walk Test (6MWT)
Berg Balance Scale (BBS)
+8 moreOther study objectives
Adverse event rate
Gait quality
Pain following each gait training session
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
79 Previous Clinical Trials
9,793 Total Patients Enrolled
7 Trials studying Stroke
2,377 Patients Enrolled for Stroke
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,371 Total Patients Enrolled
7 Trials studying Stroke
349 Patients Enrolled for Stroke
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