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NCT Number: NCT05571033

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Reflex, Abnormal Signs and Symptoms Spastic Cerebral Palsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burke Neurological Institute

White Plains, New York, 10605, United States

Location status: Recruiting

Location contact

Kathleen Friel, PhD

CONTACT

[email protected]

914-368-3116

Kathleen Friel, PhD

PRINCIPAL_INVESTIGATOR

About this study

Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. If successful, it will not only provide evidence for future clinical application but also broaden the scope for alternate or supplementary non-invasive treatment approaches to decrease spasticity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Pregnancy
  • 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)

Treatment and study plan

Spinal reflex conditioning

Behavioral

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 outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 10 meter walk test

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Measure of how long it takes the participant to walk 10 meters

  2. 6 minute walk test

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Measure the distance a participant can walk in 6 min

  3. Fugl-Meyer

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Standardized test of motor skill, range of motion, and spasticity

  4. Modified Ashworth Scale

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Measure of muscle spasticity in leg muscles

  5. Range of motion

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Measure of flexibility of leg joints

  6. Fatigue Severity Scale

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    A survey of fatigue symptoms

  7. Berg Balance Scale

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Measure of participant's ability to balance

  8. Timed up and Go

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Measure of how quickly a participant can stand from a chair, walk, return to chair, and sit

  9. Sit to Stand Test

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Time it takes for a participant can stand up five times in a row

  10. Patient Reported Outcome Measures (PROMIS) Anxiety question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about anxiety

  11. Patient Reported Outcome Measures (PROMIS) Fatigue question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about fatigue

  12. Patient Reported Outcome Measures (PROMIS) Depression question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about depression

  13. Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about General Life Satisfaction

  14. Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about General Self Efficacy

  15. Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about Meaning and Purpose

  16. Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about Self-Efficacy for Managing Chronic Conditions

  17. Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about sleep

  18. Patient Reported Outcome Measures (PROMIS) Pain Interference question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about pain

  19. Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about Ability to Participate in Social Roles and Activities

  20. Patient Reported Outcome Measures (PROMIS) Physical Function

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about physical functioning

  21. Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about Satisfaction with Social Roles and Activities

  22. Patient Reported Outcome Measures (PROMIS) Mobility question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about mobility

  23. Patient Reported Outcome Measures (PROMIS) Social Isolation question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about isolation

  24. Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    computer-based survey for participants to answer questions about hand and arm function

  25. Change in size of motor evoked potential in the brain

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    Using single pulse transcranial magnetic stimulation, we will measure the amount of energy required to evoke a leg muscle movement from a stimulus delivered to the head

  26. Manual Ability Classification System

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    A categorical measure of how well a participant can move their hands

  27. Jebsen-Taylor Test of Hand Function

    Time frame: Within one week before the first intervention session to within one week after the end of intervention

    A timed test that measures how quickly the participant can move checkers, cans, and small objects

Study contacts

Contact information is provided by the study sponsor or research team.

Devina Kumar, PhD

CONTACT

[email protected]

914-368-3160

Sponsors and collaborators

Lead sponsor

Burke Medical Research Institute

Other

Registry information

Acronym: SRC-CP

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Oct 7, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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