Integrated Management of Pronation Deformity in Cerebral Palsy

April 15, 2020 updated by: Nigar Dursun, Kocaeli University

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

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. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41050
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental Group
Patients treated by Botulinum toxin A and twister and specific home exercise program
Drug: Botulinum toxin type A
Dysport
Other: Upper extremity orthoses
Twister
Other: Home exercise program
Specific exercises for pronation deformity
ACTIVE_COMPARATOR: Conventional Therapy Group
Patients treated by Botulinum toxin A and specific home exercise program
Drug: Botulinum toxin type A
Dysport
Other: Home exercise program
Specific exercises for pronation deformity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline Modified Ashworth Scale (MAS)
Time Frame: Week 12
Tone measurement
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline passive range of supination
Time Frame: Week 12
Range of motion measurement
Week 12
Mean change from baseline angle of catch (XV3) Tardieu scale
Time Frame: Week 12
Spasticity measurement
Week 12
Mean change from baseline active range of supination
Time Frame: Week 12
Active range of motion
Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisting Hand Assessment (AHA)
Time Frame: Week 12
Bilateral hand use
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Melike Akarsu, MSc, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 26, 2018

Primary Completion (ACTUAL)

March 30, 2020

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU GOKAEK 2018/8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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