Integrated Management of Pronation Deformity in Cerebral Palsy

Kocaeli University

Status and phase: Completed; Phase 3

Conditions: Cerebral Palsy

Treatments: Other: Upper extremity orthoses; Other: Home exercise program; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03472261

KU GOKAEK 2018/8

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Patients treated by Botulinum toxin A and twister and specific home exercise program

Treatment:

Other: Home exercise program

Drug: Botulinum toxin type A

Other: Upper extremity orthoses

Conventional Therapy Group

Active Comparator group

Description:

Patients treated by Botulinum toxin A and specific home exercise program

Treatment:

Other: Home exercise program

Drug: Botulinum toxin type A