Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A

Study Overview
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Brief Summary
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Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains. In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.

Detailed Description
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Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.

Official Title
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Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Device: transcranial direct current stimulation
* Other: hybrid training model of CIMT and BIT
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of unilateral cerebral palsy able to activate wrist and finger extensors being scheduled for BoNT-A treatment for upper limb Exclusion Criteria: significant loss of wrist and or fingers history of orthopedic surgery to plegic upper limb

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: İntensive Therapy Group<br>Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT | Drug: Botulinum toxin type A<br> <br> * Other names: Botox, Dysport;Device: transcranial direct current stimulation<br> <br> * Other names: noninvasiv brain stimulation;Other: hybrid training model of CIMT and BIT<br> <br> |
| Active Comparator: Control Group<br>Children who received Botulinum toxin type A to plegic upper limb would continue their usual care | Drug: Botulinum toxin type A<br> <br> * Other names: Botox, Dysport;Other: usual care<br> <br> * Other names: physical therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assisting Hand Assesment | Bilateral Hand Function Evaluation Instrument | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jebsen Taylor Hand Function Test | Unilateral Hand Function Evaluation Instrument | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, botulinum toxin A, constraint induced movement therapy, transcranial direct current stimulation