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Behavioural Intervention

Nerve Stimulation + Knee Brace for Post-Stroke Mobility Improvement

N/A
Recruiting
Led By James S Sulzer
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged at least 18
Able to continuously walk for 30 minutes
Must not have
No functionally relevant vision impairment
No functionally relevant osteoarthritis and weight-bearing restrictions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if electrical stimulations to the rectus femoris (a thigh muscle) can help with movement for people who have post-stroke stiff-knee gait.

Who is the study for?
This trial is for adults who were independent before and can walk continuously for 30 minutes. It's specifically aimed at those with post-stroke stiff-knee gait, which means they have trouble bending their knee when walking due to a stroke. Participants should have mild to moderate impairment and be able to give consent.
What is being tested?
The study tests how electrical stimulation of the nerve that controls the thigh muscle affects reflexes in people with stiff knees after a stroke compared to those without this condition. Additionally, it examines if these reflexes are linked to changes in walking patterns.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort or skin irritation from the electrical stimulation or brace wear, muscle fatigue from prolonged walking tests, and possible temporary increase in spasticity or stiffness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can walk non-stop for 30 minutes.
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I have weakness on one side of my body after a stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My vision does not significantly impact my daily activities.
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I don't have severe joint pain or limits on my ability to support weight.
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I do not have nerve damage that affects my daily activities.
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I have never had a serious injury to my legs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surface electromyographic recording of leg muscles during different conditions
Secondary study objectives
Circumduction measure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Post-stroke Stiff-Knee Gait ParticipantsExperimental Treatment1 Intervention
Individuals with post-stroke Stiff-Knee gait
Group II: Healthy IndividualsExperimental Treatment2 Interventions
Healthy Individuals

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
378 Previous Clinical Trials
86,545 Total Patients Enrolled
10 Trials studying Stroke
1,043 Patients Enrolled for Stroke
MetroHealth Medical CenterLead Sponsor
120 Previous Clinical Trials
22,016 Total Patients Enrolled
16 Trials studying Stroke
899 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,484 Total Patients Enrolled
86 Trials studying Stroke
5,793 Patients Enrolled for Stroke
James S SulzerPrincipal InvestigatorCase Western Reserve University

Media Library

Peripheral nerve stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04947865 — N/A
Stroke Research Study Groups: Post-stroke Stiff-Knee Gait Participants, Healthy Individuals
Stroke Clinical Trial 2023: Peripheral nerve stimulation Highlights & Side Effects. Trial Name: NCT04947865 — N/A
Peripheral nerve stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04947865 — N/A
~6 spots leftby Jun 2025
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