Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05571033

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

Led by Burke Medical Research Institute · Updated on 2023-09-26

12

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a novel intervention called operant conditioning of the soleus H reflex in adults with spastic cerebral palsy (CP). Spasticity in CP causes significant challenges due to increased muscle tone and activity restrictions, resulting from upper motor neuron injury and disrupted motor tone control. This study aims to reduce spasticity through a non-invasive technique that has shown promising effects in other neurological conditions, potentially offering a new or supplementary treatment approach for people with CP. Participants will undergo 6 baseline sessions followed by 24 conditioning sessions held three times per week. During each session, electrical pulses will be applied to the tibial nerve to elicit the soleus H reflex while participants stand comfortably. They will complete trials without and with visual feedback to learn how to reduce the reflex magnitude in their calf muscle on the more-affected leg. The intervention is behavioral and non-invasive, focusing on training participants to decrease their reflex activity. Throughout the study, clinical and physiological assessments collected at baseline will be repeated after the intervention and during follow-ups at 2 weeks, 1 month, and 3 months. Outcome measures include soleus H-reflex size, walking tests, motor function scales, balance and mobility tests, and various patient-reported outcome measures related to anxiety, fatigue, depression, physical function, and social participation. Researchers will also monitor session attendance and evaluate changes in motor evoked potentials and hand function. The study duration covers the baseline, intervention, and follow-up periods to assess both immediate and retained effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Uncontrolled diabetes
  • Weak dorsiflexion
  • History of cardiac conditions
  • Cognitive deficits interfering with study procedures
  • Botox treatment within 2 months of the study
  • History of ankle surgeries in affected leg (e.g., Dorsal root rhizotomy)
  • Regular use of electrical stimulation to lower extremity muscles
  • Cochlear or metal implantations in the body
  • History of seizure after age 2 years
  • Current use of antiseizure medicines
  • Any metal or magnetic components in the head (surgical clips, metal work)
  • Implanted devices or cardiac pacemakers
  • Skin disorders
  • Damaged skin (wounds, broken skin, or recent scar tissue)
  • Allergy to latex (tape)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Approximately 10 weeks

Participants attend 30 sessions involving operant conditioning of the soleus stretch reflex to reduce spasticity. The first 6 sessions are baseline measures, followed by 24 conditioning sessions where participants learn to decrease reflex activity in their calf muscle on the more-affected leg.

3 visits per week for 10 weeks

Trial Site Locations

Total: 1 location

1

Burke Neurological Institute

White Plains, New York, United States, 10605

Actively Recruiting

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Research Team

D

Devina Kumar, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Acquisition of a simple motor skill: task-dependent adaptation and long-term changes in the human soleus stretch reflex.

N Mrachacz-Kersting, U G Kersting, P de Brito Silva...

https://pubmed.ncbi.nlm.nih.gov/31166816