Integrated Management of Pronation Deformity in Cerebral Palsy

Phase 3

Completed

• Conditions: Cerebral Palsy
• Interventions: Drug: Botulinum toxin type A; Other: Upper extremity orthoses; Other: Home exercise program

• Registration Number: NCT03472261
• Lead Sponsor: Kocaeli University

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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-21
• Study Start: 2018-03-26
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Botulinum toxin type A	Patients treated by Botulinum toxin A and twister and specific home exercise program
Experimental Group	Upper extremity orthoses	Patients treated by Botulinum toxin A and twister and specific home exercise program
Experimental Group	Home exercise program	Patients treated by Botulinum toxin A and twister and specific home exercise program
Conventional Therapy Group	Botulinum toxin type A	Patients treated by Botulinum toxin A and specific home exercise program
Conventional Therapy Group	Home exercise program	Patients treated by Botulinum toxin A and specific home exercise program

Primary Outcome Measures

Name	Time	Method
Mean change from baseline Modified Ashworth Scale (MAS)	Week 12	Tone measurement

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline passive range of supination	Week 12	Range of motion measurement
Mean change from baseline angle of catch (XV3) Tardieu scale	Week 12	Spasticity measurement
Mean change from baseline active range of supination	Week 12	Active range of motion

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey