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NCT05571033NARecruitingAccepts Healthy Volunteers

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

Burke Medical Research Institute

Start Date

9/30/2022

Completion Date

12/31/2026

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

BEHAVIORAL

Spinal reflex conditioning

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Conditions

Cerebral PalsySpastic Cerebral Palsy

Locations

Burke Neurological Institute

White Plains, New York 10605

United States