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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Soleus H-Reflex size [Срок оценки: Within one week before first intervention session to within one week after the end of intervention]
• Attendance [Срок оценки: At the end of the intervention, we will count the number of sessions each participant completed]

Вторичные конечные точки (12)

• 10 meter walk test [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• 6 minute walk test [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Fugl-Meyer [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Modified Ashworth Scale [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Range of motion [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Fatigue Severity Scale [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Berg Balance Scale [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Timed up and Go [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Sit to Stand Test [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Patient Reported Outcome Measures (PROMIS) Anxiety question bank [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Patient Reported Outcome Measures (PROMIS) Fatigue question bank [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]
• Patient Reported Outcome Measures (PROMIS) Depression question bank [Срок оценки: Within one week before the first intervention session to within one week after the end of intervention]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Burke Neurological Institute — White Plains

Публикации

• Thompson AK, Chen XY, Wolpaw JR. Soleus H-reflex operant conditioning changes the H-reflex recruitment curve. Muscle Nerve. 2013 Apr;47(4):539-44. doi: 10.1002/mus.23620. Epub 2012 Dec 21. PMID 23281107
• Mrachacz-Kersting N, Kersting UG, de Brito Silva P, Makihara Y, Arendt-Nielsen L, Sinkjaer T, Thompson AK. Acquisition of a simple motor skill: task-dependent adaptation and long-term changes in the human soleus stretch reflex. J Neurophysiol. 2019 Jul 1;122(1):435-446. doi: 10.1152/jn.00211.2019. Epub 2019 Jun 5. PMID 31166816

Идентификаторы

NCT: NCT05571033 · SRC-CP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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