Conditioning the Soleus Reflex in Adults with Cerebral Palsy
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
This study is testing a new way to help adults with cerebral palsy reduce muscle tightness and improve movement by using special conditioning sessions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Burke Medical Research Institute Academic / other |
| Locations | 1 site (White Plains, New York) |
| Trial ID | NCT05571033 on ClinicalTrials.gov |
What this trial studies
This study involves 12 adults with spastic cerebral palsy who will undergo a series of conditioning sessions aimed at reducing muscle spasticity. Participants will complete 6 baseline sessions followed by 24 conditioning sessions, where the soleus H reflex will be elicited to decrease its magnitude. Assessments will be conducted at baseline and after the intervention, with follow-ups at 2 weeks, 1 month, and 3 months. The goal is to explore a non-invasive method to improve motor function and reduce spasticity in individuals with cerebral palsy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above with a diagnosis of spastic cerebral palsy and stable medical backgrounds.
Not a fit: Patients with uncontrolled diabetes, cognitive deficits, or recent botox treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce spasticity and improve motor function in adults with cerebral palsy.
How similar studies have performed: Previous studies have shown promising results with similar non-invasive approaches to reduce spasticity in other populations, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
White Plains, New York
- Burke Neurological Institute — White Plains, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kathleen Friel, PhD — Burke Neurological Institute
- Study coordinator: Devina Kumar, PhD
- Email: dek4004@med.cornell.edu
- Phone: 914-368-3160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.