Sensorimotor Control During Postural Transitions in CP

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Children and young adults with CP can have trouble with daily tasks such as standing up, sitting down on the chair and turning. The difficulty in maintaining balance sometimes lead to falls. This raises risk of disability in CP as children age into teens and adults. Current treatments are not very effective. In this study, children and young adults will be asked to stand up from a stool, walk in a straight line, turn, walk back and sit down on the stool. Participants will receive electrical stimulation at a very low intensity that cannot be felt to help increase their sensory perception. The investigators will evaluate treatment by testing balance, and other functional measures.

Official Title
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Neuromotor Control During Postural Transitions in Children and Young Adults With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Stochastic Resonance Electric Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for individuals with CP: Age 8-24 Diagnosis of CP GMFCS level I-II Ability to stand up from a chair and start walking. Migration index of proximal hip (MIGR) < 40% femoral head covering in acetabulum At least 0° passive dorsiflexion range of motion (ROM) Sufficient visuoperceptual, cognitive and communication skills Seizure-free or well-controlled seizures No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability Ability to communicate pain or discomfort Ability to assent/consent or obtain parent/guardian consent Exclusion Criteria for individuals with CP: Scoliosis with primary curve > 40% Spinal fusions extending into pelvis Lower Extremity joint instability or dislocation Severe tactile hypersensitivity Lower extremity botulinum injections in the past 6 months Implanted medical device or metal contraindicative of the application of SR Pregnancy (self-reported) Severe lower extremity spasticity (Modified Ashworth Scale score of 4 or greater) History of pulmonary disease limiting exercise tolerance (Asthma Control Test screen) History of cardiac disease (American Heart Association screen) Severely limited range of joint motion/ irreversible muscle contractures Lower extremity surgery or significant injury within last 1 yr. Inclusionary criteria for typically developing volunteers: Aged 8-24 years old Ability to stand up from a chair and start walking without an assistive device or orthoses Able to communicate discomfort during testing and can follow multi-step directions Has not been diagnosed with any neurological or balance disorders Seizure-free Exclusionary criteria for typically developing volunteers: Diagnosis of CP Significant scoliosis with primary curve > 40° Lower extremity surgery or fractures in the year prior testing Joint instability or dislocation in the lower extremities Severe tactile hypersensitivity A history of selective dorsal root rhizotomy Botulinum toxin injections in the lower extremities within the past 6 months Marked visual or hearing deficits Any embedded metal that may be contraindicated with application of SR Severe spasticity of the lower extremity muscles (eg. a score of 4 on the Modified Ashworth) Pregnancy (self-reported) Severely limited joint range of motion/ irreversible muscle contractures that would not be candidates for soft-tissue surgery Learning disabilities History of neurological disorders Balance and/or postural impairment

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross sectional study in children with CP and age matched TD (typical developing). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a no stochastic resonance (noSR) condition while performing postural Transitions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stochastic Resonance stimulation<br>During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test while receiving stochastic resonance stimulation on legs and hip. | Device: Stochastic Resonance Electric Stimulation<br>* Subjects will be asked to perform postural transitions like sit to stand, gait initiation, sit to walk and Timed up and the Go (TUG) functional test. This will entail a subsensory electrical signal with a white noise frequency distribution. Proprioceptive SR electrical stimulation will be delivered by BIOPAC Systems, Inc. stimulators that are current limited to deliver less than 10 milli ampere of current. Electrical stimulation will be delivered to muscles and joints along the legs and hips. The stimulation intensity will be very low, below the sensory threshold of the participant.<br>|
| No Intervention: No Stochastic Resonance stimulation<br>During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test without receiving any electrical stimulation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COM | Change in the Center of Mass (COM) trajectories while performing various activities. | 2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM | 
| Change in COP | Change in the Center of Pressure (COP) trajectories while performing various activities. | 2 assessment points: Baseline - pre stimulation COP, and at the end of the session with stimulation (Day 1)- Post stimulation COP | 
| Total time | Time taken to complete the task. | Baseline, Post Stimulation (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance Control, Stochastic Resonance, Postural Transitions