Sensory Stimulation During CIMT

Study Overview
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Brief Summary
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The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.

Detailed Description
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The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.

Official Title
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Sensory Stimulation During Constraint-Induced Movement Therapy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: Standardized Constraint-Induced Movement Therapy
* Behavioral: Vibration
* Behavioral: Placebo (for vibration)


Participation Criteria
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Eligibility Criteria
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Between the ages of 3 and 9 Have unilateral upper limb motor weakness. Use the affected extremity as a gross assist during play and self-care activities. No significant developmental delays that would limit spontaneous use of the more affected extremity. Be ambulatory for their age and demonstrate intact balance and protective reactions throughout the less involved upper extremity. No other health impairment other than hemiparesis.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration<br>The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy. | Behavioral: Standardized Constraint-Induced Movement Therapy<br>* The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.<br>Behavioral: Vibration<br>* Vibration applied to the wrist.<br>|
| Placebo Comparator: No Vibration<br>The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. | Behavioral: Standardized Constraint-Induced Movement Therapy<br>* The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.<br>Behavioral: Placebo (for vibration)<br>* No vibration applied to the wrist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (Total Number of Hours That Participants Wear the Device) | total number of hours that participants wear the device | through 5-day study completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiplegic, pediatric, hand function