NCT05571033 · Burke Medical Research Institute
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
(SRC-CP)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Spinal reflex conditioning
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.
Primary outcome measures
Soleus H-Reflex size
Time frame: Within one week before first intervention session to within one week after the end of intervention
Size of h-reflex as measured by EMG
Attendance
Time frame: At the end of the intervention, we will count the number of sessions each participant completed
Measure of feasibility of protocol, whether or not people can attend all sessions
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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)
Where
- White Plains, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 26, 2023 · Source of record for eligibility and locations