Status:
WITHDRAWN
Neural Operant Conditioning
Lead Sponsor:
MetroHealth Medical Center
Conditions:
Stroke
Chronic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 s...
Detailed Description
The study purpose is to investigate the possibility and later effect of spinal reflex self-regulation in post-stroke stiff-knee gait. The intervention will consist of direct current surface stimulatio...
Eligibility Criteria
Inclusion
- Sign and date consent form
- At least 3 months since stroke event
- Over 18 years of age at time of eligibility
- Ability to stand upright and walk for at least 5 minutes
- Premorbidly independent
- Mild to moderate gait impairment
- Reduced knee flexion during walking relative to the unimpaired side
- Unilateral hemiparesis of the lower limbs
- Ability to evoke muscle responses through peripheral nerve stimulation, spinal cord stimulation, and transcranial magnetic stimulation
- Medically stable
- Skin intact on hemiparetic leg, abdomen, and scalp
- Ability to evoke muscle responses and/or reflex responses through peripheral nerve stimulation, spinal cord stimulation, and/or transcranial magnetic stimulation
Exclusion
- Co-existing neurological condition other than prior stroke involving the hemiparetic lower limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
- History of lower limb musculoskeletal injury
- Functionally relevant osteoarthritis and weight bearing restriction
- Functionally relevant polyneuropathy resulting in lack of sensation in the lower leg
- Functionally relevant cognitive impairment
- Functionally relevant vision impairment
- Pregnant
- Botox injection to the ipsilateral leg in the last 12 weeks or taking oral anti-spasticity medications
- Taking part in physical therapy for any walking-related impairment
- Cardiac pacemaker or other implanted electronic systems
- Uncontrolled seizure disorder
- Use of seizure lowering threshold medications and the discretion of the study physician
- Deficits in communication that interfere with reasonable study participation
- Severely impaired cognition and communication
- Severe lower limb pain
Key Trial Info
Start Date :
December 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06113965
Start Date
December 31 2024
End Date
May 31 2028
Last Update
March 10 2025
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109