Neural Operant Conditioning for Stroke-Related Walking Difficulties

Overseen By Kristine Hansen, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Anti-spasticity, Seizure threshold

Disqualifiers: Neurological conditions, Musculoskeletal injury, Osteoarthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if operant conditioning can reduce spasticity in order to improve walking in stroke patient. The main questions it aims to answer are: * Can participants self-regulate reflex excitability * Can participants self-regulate reflex, reduce spasticity and improve walking Participants will undergo surface stimulation to evoke spinal reflexes and will be asked to control these reflexes therefore reducing spasticity. Researchers will compare result to able bodied participants to see if \[insert effects\]

Research Team

James Sulzer, PhD

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have weakness on one side of my lower body.

Sign and date consent form

You were able to take care of yourself before getting sick.

Exclusion Criteria

Deficits in communication that interfere with reasonable study participation

I have severe difficulties in thinking and communicating.

I have seizures that are not controlled by medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surface stimulation to evoke spinal reflexes and attempt to self-regulate reflex excitability over multiple sessions

12 weeks

Multiple sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Assessments at 4, 12, and 24 weeks post-treatment

Treatment Details

Interventions

• Neural Operant Conditioning

Trial Overview 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.

Participant Groups

Group I: Experimental: Post-stroke Stiff-Knee Gait Participants Experimental Treatment 1 Intervention

Individuals with post-stroke Stiff-Knee gait

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+