A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A
Overview
- Phase
- Phase 3
- Intervention
- Home exercise program
- Conditions
- Cerebral Palsy
- Sponsor
- Kocaeli University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Mean change from baseline Modified Ashworth Scale (MAS)
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
Nigar Dursun
Professor
Kocaeli University
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
Arms & Interventions
Experimental Group
Patients treated by Botulinum toxin A and twister and specific home exercise program
Intervention: Home exercise program
Experimental Group
Patients treated by Botulinum toxin A and twister and specific home exercise program
Intervention: Botulinum toxin type A
Experimental Group
Patients treated by Botulinum toxin A and twister and specific home exercise program
Intervention: Upper extremity orthoses
Conventional Therapy Group
Patients treated by Botulinum toxin A and specific home exercise program
Intervention: Botulinum toxin type A
Conventional Therapy Group
Patients treated by Botulinum toxin A and specific home exercise program
Intervention: Home exercise program
Outcomes
Primary Outcomes
Mean change from baseline Modified Ashworth Scale (MAS)
Time Frame: Week 12
Tone measurement
Secondary Outcomes
- Mean change from baseline passive range of supination(Week 12)
- Mean change from baseline angle of catch (XV3) Tardieu scale(Week 12)
- Mean change from baseline active range of supination(Week 12)