NCT05571033 Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
| NCT ID | NCT05571033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Burke Medical Research Institute |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-09-30 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2022-09-30 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Kathleen Friel, PhD
PRINCIPAL INVESTIGATOR
Burke Neurological Institute
Frequently Asked Questions
Who can join the NCT05571033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05571033 currently recruiting?
Yes, NCT05571033 is actively recruiting participants. Contact the research team at dek4004@med.cornell.edu for enrollment information.
Where is the NCT05571033 trial being conducted?
This trial is being conducted at White Plains, United States.
Who is sponsoring the NCT05571033 clinical trial?
NCT05571033 is sponsored by Burke Medical Research Institute. The principal investigator is Kathleen Friel, PhD at Burke Neurological Institute. The trial plans to enroll 12 participants.
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