Integrated Management of Pronation Deformity in Cerebral Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2020-03-30

Brief Summary

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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. .

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Detailed Description

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

Dysport

Upper extremity orthoses

Intervention Type OTHER

Twister

Home exercise program

Intervention Type OTHER

Specific exercises for pronation deformity

Conventional Therapy Group

Patients treated by Botulinum toxin A and specific home exercise program

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

Dysport

Home exercise program

Intervention Type OTHER

Specific exercises for pronation deformity

Interventions

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Botulinum toxin type A

Dysport

Intervention Type DRUG

Upper extremity orthoses

Twister

Intervention Type OTHER

Home exercise program

Specific exercises for pronation deformity

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No