Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBurke Medical Research Institute
About this trial
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
This trial accepts healthy volunteersQualifiers
Age 18 and above
Diagnosis of spastic Cerebral Palsy
Gross Motor Function Classification System level I-III
Stable medical background
Disqualifiers
Pregnancy
uncontrolled diabetes
weak dorsiflexion
History of cardiac conditions
Trial design
Design model
Single group
Treatments tested in this trial
Spinal reflex conditioning
BehavioralEach 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Spinal reflex conditioningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Soleus H-Reflex size
Size of h-reflex as measured by EMG
Time frame
Within one week before first intervention session to within one week after the end of intervention2
Attendance
Measure of feasibility of protocol, whether or not people can attend all sessions
Time frame
At the end of the intervention, we will count the number of sessions each participant completedSecondary outcomes
1
10 meter walk test
Measure of how long it takes the participant to walk 10 meters
Time frame
Within one week before the first intervention session to within one week after the end of intervention2
6 minute walk test
Measure the distance a participant can walk in 6 min
Time frame
Within one week before the first intervention session to within one week after the end of intervention3
Fugl-Meyer
Standardized test of motor skill, range of motion, and spasticity
Time frame
Within one week before the first intervention session to within one week after the end of intervention4
Modified Ashworth Scale
Measure of muscle spasticity in leg muscles
Time frame
Within one week before the first intervention session to within one week after the end of interventionSponsors and contacts
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Source ClinicalTrials.gov