Cerebral Palsy Clinical Trial
— SRC-CPOfficial title:
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 and above 2. Diagnosis of spastic Cerebral Palsy 3. Gross Motor Function Classification System level I-III 4. Stable medical background 5. Current medication will remain unchanged for 3 months 6. Provides informed consent 7. can walk at least 10 meters with or without assistive device 8. meets minimum study procedure requirements (elicitation of H-reflex). Exclusion Criteria: 1. Pregnancy 2. uncontrolled diabetes 3. weak dorsiflexion 4. History of cardiac conditions 5. cognitive deficits that interfere with study procedure and steps for completion 6. Botox within 2 months of the study 7. H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.) 8. regular use of electrical stimulation to lower extremity muscles 9. Cochlear or metal implantations on body 10. No history of seizure after age 2 years 11. Current use of antiseizure medicines 12. Any metal or magnetic components in the head (surgical clips, metal work etc.) 13. Implanted device or cardiac pacemakers (applicable for DS8R too) 14. Skin disorders 15. Damaged skin (wounds, broken skin, or recent scar tissue) 16. Allergy to latex (tape) |
Country | Name | City | State |
---|---|---|---|
United States | Burke Neurological Institute | White Plains | New York |
Lead Sponsor | Collaborator |
---|---|
Burke Medical Research Institute |
United States,
Mrachacz-Kersting N, Kersting UG, de Brito Silva P, Makihara Y, Arendt-Nielsen L, Sinkjaer T, Thompson AK. Acquisition of a simple motor skill: task-dependent adaptation and long-term changes in the human soleus stretch reflex. J Neurophysiol. 2019 Jul 1;122(1):435-446. doi: 10.1152/jn.00211.2019. Epub 2019 Jun 5. — View Citation
Thompson AK, Chen XY, Wolpaw JR. Soleus H-reflex operant conditioning changes the H-reflex recruitment curve. Muscle Nerve. 2013 Apr;47(4):539-44. doi: 10.1002/mus.23620. Epub 2012 Dec 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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