Integrated Management of Pronation Deformity in Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .

Detailed Description
-----------------
Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature. In this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.

Official Title
-----------------
A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A
* Other: Upper extremity orthoses
* Other: Home exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cerebral palsy MAS score of pronator muscles at least 2 Gross Motor Functional Classification Scale level of I-IV Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles Exclusion Criteria: Severe cognitive or behavioural problems Less than 40 degrees of available passive range of motion in pronation Severe dystonia in the affected upper limb Received orthopedic surgery to affected upper limb

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Patients treated by Botulinum toxin A and twister and specific home exercise program | Drug: Botulinum toxin type A<br>* Dysport<br>Other: Upper extremity orthoses<br>* Twister<br>Other: Home exercise program<br>* Specific exercises for pronation deformity<br>|
| Active Comparator: Conventional Therapy Group<br>Patients treated by Botulinum toxin A and specific home exercise program | Drug: Botulinum toxin type A<br>* Dysport<br>Other: Home exercise program<br>* Specific exercises for pronation deformity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline Modified Ashworth Scale (MAS) | Tone measurement | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline passive range of supination | Range of motion measurement | Week 12 | 
| Mean change from baseline angle of catch (XV3) Tardieu scale | Spasticity measurement | Week 12 | 
| Mean change from baseline active range of supination | Active range of motion | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral palsy, botulinum toxin-A, pronator deformity