- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Kocaeli, Turkey, 41050
- Kocaeli University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Dysport
Twister
Specific exercises for pronation deformity
|
ACTIVE_COMPARATOR: Conventional Therapy Group
Patients treated by Botulinum toxin A and specific home exercise program
|
Dysport
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
Sponsor
Investigators
- Principal Investigator: Melike Akarsu, MSc, Kocaeli University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Brain Damage, Chronic
- Cerebral Palsy
- Congenital Abnormalities
- Paralysis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- KU GOKAEK 2018/8
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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