Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy

Study Overview
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Brief Summary
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12 adults with spastic CP will complete 6 baseline sessions and 24 down conditioning sessions held 3 times/week. All clinical and physiological assessments collected at baseline will be reassessed after study completion, and follow ups after 2 weeks, 1 month and 3 months. The soleus H reflex (electric analogue of the stretch reflex) will be elicited in all sessions. In each session, participants will complete 20 baseline trials and 225 down conditioning trials to decrease the magnitude of the H-Reflex.

Detailed Description
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Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. If successful, it will not only provide evidence for future clinical application but also broaden the scope for alternate or supplementary non-invasive treatment approaches to decrease spasticity.

Official Title
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Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy

Conditions
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Cerebral Palsy, Spastic Cerebral Palsy

Intervention / Treatment
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* Behavioral: Spinal reflex conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Diagnosis of spastic Cerebral Palsy Gross Motor Function Classification System level I-III Stable medical background Current medication will remain unchanged for 3 months Provides informed consent can walk at least 10 meters with or without assistive device meets minimum study procedure requirements (elicitation of H-reflex). Exclusion Criteria: Pregnancy uncontrolled diabetes weak dorsiflexion History of cardiac conditions cognitive deficits that interfere with study procedure and steps for completion Botox within 2 months of the study H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.) regular use of electrical stimulation to lower extremity muscles Cochlear or metal implantations on body No history of seizure after age 2 years Current use of antiseizure medicines Any metal or magnetic components in the head (surgical clips, metal work etc.) Implanted device or cardiac pacemakers (applicable for DS8R too) Skin disorders Damaged skin (wounds, broken skin, or recent scar tissue) Allergy to latex (tape)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Each participant will serve as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal reflex conditioning<br>The OC intervention includes 6 baseline sessions and 24 conditioning/ no conditioning sessions held 3 times/week. To elicit an H-reflex, participants will be asked to stand in a comfortable position. Small pulses of energy will be applied to a nerve in the leg called the tibial nerve. We will record when the participant maintains leg muscle activity. During the intervention, participants will be trained to decrease their reflex in their calf. | Behavioral: Spinal reflex conditioning<br>* Each participant will serve as their own control. The intervention is 30 sessions. The first 6 sessions are baseline measures of reflexes. The remaining sessions will engage participants in learning how to decrease their reflex activity in their calf muscle on the more-affected leg. Each intervention visit will involve 20 trials in which participants do not get visual feedback about their performance, then 225 trials with visual feedback.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soleus H-Reflex size | Size of h-reflex as measured by EMG | Within one week before first intervention session to within one week after the end of intervention | 
| Attendance | Measure of feasibility of protocol, whether or not people can attend all sessions | At the end of the intervention, we will count the number of sessions each participant completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test | Measure of how long it takes the participant to walk 10 meters | Within one week before the first intervention session to within one week after the end of intervention | 
| 6 minute walk test | Measure the distance a participant can walk in 6 min | Within one week before the first intervention session to within one week after the end of intervention | 
| Fugl-Meyer | Standardized test of motor skill, range of motion, and spasticity | Within one week before the first intervention session to within one week after the end of intervention | 
| Modified Ashworth Scale | Measure of muscle spasticity in leg muscles | Within one week before the first intervention session to within one week after the end of intervention | 
| Range of motion | Measure of flexibility of leg joints | Within one week before the first intervention session to within one week after the end of intervention | 
| Fatigue Severity Scale | A survey of fatigue symptoms | Within one week before the first intervention session to within one week after the end of intervention | 
| Berg Balance Scale | Measure of participant's ability to balance | Within one week before the first intervention session to within one week after the end of intervention | 
| Timed up and Go | Measure of how quickly a participant can stand from a chair, walk, return to chair, and sit | Within one week before the first intervention session to within one week after the end of intervention | 
| Sit to Stand Test | Time it takes for a participant can stand up five times in a row | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Anxiety question bank | computer-based survey for participants to answer questions about anxiety | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Fatigue question bank | computer-based survey for participants to answer questions about fatigue | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Depression question bank | computer-based survey for participants to answer questions about depression | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank | computer-based survey for participants to answer questions about General Life Satisfaction | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank | computer-based survey for participants to answer questions about General Self Efficacy | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank | computer-based survey for participants to answer questions about Meaning and Purpose | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank | computer-based survey for participants to answer questions about Self-Efficacy for Managing Chronic Conditions | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank | computer-based survey for participants to answer questions about sleep | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Pain Interference question bank | computer-based survey for participants to answer questions about pain | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank | computer-based survey for participants to answer questions about Ability to Participate in Social Roles and Activities | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Physical Function | computer-based survey for participants to answer questions about physical functioning | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities | computer-based survey for participants to answer questions about Satisfaction with Social Roles and Activities | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Mobility question bank | computer-based survey for participants to answer questions about mobility | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Social Isolation question bank | computer-based survey for participants to answer questions about isolation | Within one week before the first intervention session to within one week after the end of intervention | 
| Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank | computer-based survey for participants to answer questions about hand and arm function | Within one week before the first intervention session to within one week after the end of intervention | 
| Change in size of motor evoked potential in the brain | Using single pulse transcranial magnetic stimulation, we will measure the amount of energy required to evoke a leg muscle movement from a stimulus delivered to the head | Within one week before the first intervention session to within one week after the end of intervention | 
| Manual Ability Classification System | A categorical measure of how well a participant can move their hands | Within one week before the first intervention session to within one week after the end of intervention | 
| Jebsen-Taylor Test of Hand Function | A timed test that measures how quickly the participant can move checkers, cans, and small objects | Within one week before the first intervention session to within one week after the end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hoffman Reflex, Spinal Reflex Conditioning