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Completed

NCT Number: NCT03472261

Integrated Management of Pronation Deformity in Cerebral Palsy

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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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Dysport

Upper extremity orthoses

Other

Twister

Home exercise program

Other

Specific exercises for pronation deformity

Primary outcomes

  1. Mean change from baseline Modified Ashworth Scale (MAS)

    Time frame: Week 12

    Tone measurement

Secondary outcomes

  1. Mean change from baseline passive range of supination

    Time frame: Week 12

    Range of motion measurement

  2. Mean change from baseline angle of catch (XV3) Tardieu scale

    Time frame: Week 12

    Spasticity measurement

  3. Mean change from baseline active range of supination

    Time frame: Week 12

    Active range of motion

Other outcomes

  1. Assisting Hand Assessment (AHA)

    Time frame: Week 12

    Bilateral hand use

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2018
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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