Integrated Management of Pronation Deformity in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472261
• Other study ID #: KU GOKAEK 2018/8
• Status: Completed
• Phase: Phase 3
• Start date: March 26, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Congenital Abnormalities
• Paralysis

Intervention

Drug:
• Botulinum toxin type A
Dysport

Other:
• Upper extremity orthoses
Twister
• Home exercise program
Specific exercises for pronation deformity

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assisting Hand Assessment (AHA)	Bilateral hand use	Week 12
Primary	Mean change from baseline Modified Ashworth Scale (MAS)	Tone measurement	Week 12
Secondary	Mean change from baseline passive range of supination	Range of motion measurement	Week 12
Secondary	Mean change from baseline angle of catch (XV3) Tardieu scale	Spasticity measurement	Week 12
Secondary	Mean change from baseline active range of supination	Active range of motion	Week 12