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Behavioural Intervention

Neural Operant Conditioning for Stroke-Related Walking Difficulties

N/A

Recruiting

Led By James Sulzer, PhD

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral hemiparesis of the lower limbs

At least 3 months since stroke event

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment

Awards & highlights

Study Summary

This trial is testing if operant conditioning can reduce spasticity in stroke patients, allowing them to improve walking. Participants will be asked to control spinal reflexes to reduce spasticity and researchers will compare results to able-bodied people.

Who is the study for?

This trial is for adults over 18 who had a stroke at least 3 months ago, can stand and walk for five minutes, and had independent mobility before their stroke. They should have reduced knee flexion when walking and be able to respond to nerve stimulation. People with severe cognitive issues, lower limb pain or injuries, certain neurological conditions other than stroke, uncontrolled seizures, or those pregnant cannot participate.Check my eligibility

What is being tested?

The study tests if operant conditioning with peripheral nerve stimulation can help stroke patients control spinal reflexes to reduce spasticity and improve walking. Participants' results will be compared with those of able-bodied individuals to assess the effectiveness of this technique.See study design

What are the potential side effects?

Potential side effects may include discomfort from the stimulation device, skin irritation where it's applied, muscle fatigue due to repeated use during sessions, and possible mild pain or soreness after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have weakness on one side of my lower body.

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It has been over 3 months since my stroke.

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I can stand and walk for at least 5 minutes without help.

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My knee doesn't bend as much as the other when I walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surface electromyographic recording of leg muscles

Secondary outcome measures

10 meter walk test

Five Times Sit to Stand Test

TMS

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Post-stroke Stiff-Knee Gait ParticipantsExperimental Treatment1 Intervention

Individuals with post-stroke Stiff-Knee gait

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor

114 Previous Clinical Trials

21,329 Total Patients Enrolled

16 Trials studying Stroke

899 Patients Enrolled for Stroke

James Sulzer, PhDPrincipal InvestigatorMetroHealth Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have enrolled in this clinical trial?

"Yes, clinicaltrials.gov provides evidence that this medical study is currently recruiting participants. It was first announced on May 31st 2024 and the details were updated most recently on October 27th 2023. The trial requires a total of 60 volunteers from 1 site to participate."

Answered by AI

Are recruitment efforts still underway for this trial?

"Correct, a review of the clinicaltrials.gov website reveals that this medical trial is still recruiting participants as of October 27th 2023. This study commenced on May 31st 2024 and is targeting 60 patients from one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neural Operant Conditioning

James Sulzer 2024. "Neural Operant Conditioning". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06113965.