Chronic Stroke, Gait, Hemiplegic, Gait, Spastic, Stroke, Walking, Difficulty
Conditions
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 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 \[insert effects\]
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 stimulation of the peripheral nerves using electrical stimulation. Stimulation will evoke a motor response that will be collected through surface EMG electrodes and processed to depict a measure of the response as feedback to the participant to complete the loop of operant conditioning. The participant will attempt to modulate their responses over multiple sessions to cause this depiction to either increase or decrease its value depending on an established target. .
Interventions
DEVICEPeripheral Nerve Stimulation
Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity
Sponsors
MetroHealth Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Sign and date consent form 2. At least 3 months since stroke event 3. Over 18 years of age at time of eligibility 4. Ability to stand upright and walk for at least 5 minutes 5. Premorbidly independent 6. Mild to moderate gait impairment 7. Reduced knee flexion during walking relative to the unimpaired side 8. Unilateral hemiparesis of the lower limbs 9. Ability to evoke muscle responses through peripheral nerve stimulation, spinal cord stimulation, and transcranial magnetic stimulation 10. Medically stable 11. Skin intact on hemiparetic leg, abdomen, and scalp 12. Ability to evoke muscle responses and/or reflex responses through peripheral nerve stimulation, spinal cord stimulation, and/or transcranial magnetic stimulation
Exclusion criteria
1. Co-existing neurological condition other than prior stroke involving the hemiparetic lower limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS). 2. History of lower limb musculoskeletal injury 3. Functionally relevant osteoarthritis and weight bearing restriction 4. Functionally relevant polyneuropathy resulting in lack of sensation in the lower leg 5. Functionally relevant cognitive impairment 6. Functionally relevant vision impairment 7. Pregnant 8. Botox injection to the ipsilateral leg in the last 12 weeks or taking oral anti-spasticity medications 9. Taking part in physical therapy for any walking-related impairment 10. Cardiac pacemaker or other implanted electronic systems 11. Uncontrolled seizure disorder 12. Use of seizure lowering threshold medications and the discretion of the study physician 13. Deficits in communication that interfere with reasonable study participation 14. Severely impaired cognition and communication 15. Severe lower limb pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface electromyographic recording of leg muscles | baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment | Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10 meter walk test | baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment | 10 meter walk test with collection of gait kinematics captured using an inertial motion capture camera system |
| quadriceps pendulum test | baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment | This is a method of evaluating spasticity using gravity to provoke the muscular stretch reflex allowing for the collection of joint angle data. This data will aid in assessing changes in joint angles as a result of training. |
| Five Times Sit to Stand Test | baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment | measures lower extremity functional strength. This test will measure your leg strength by asking you to sit down and stand up from a chair 5 times as fast as possible. |
| Transcranial Magnetic Stimulation (TMS) | Baseline, Week 12 - end of treatment | non-invasive brain stimulation device, will be used to elicit a motor evoked response in participants via low frequency stimulation to the cortical regions associated with the muscles being investigated. This approach will test the integrity of the participant's CST in relation to the intervention and assessments being conducted |
Countries
United States
Outcome results
None listed