NCT03472261

Integrated Management of Pronation Deformity in Cerebral Palsy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Kocaeli University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	Dysport
OTHER	Upper extremity orthoses	Twister
OTHER	Home exercise program	Specific exercises for pronation deformity

Timeline

• Start date: 2018-03-26
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2018-03-21
• Last updated: 2020-04-16

Locations

1 site across 1 country: Turkey (Türkiye)