Integrated Management of Pronation Deformity in Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Botulinum toxin type A
Upper extremity orthoses
Home exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, botulinum toxin-A, pronator deformity
Eligibility Criteria
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
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Conventional Therapy Group
Arm Description
Patients treated by Botulinum toxin A and twister and specific home exercise program
Patients treated by Botulinum toxin A and specific home exercise program
Outcomes
Primary Outcome Measures
Mean change from baseline Modified Ashworth Scale (MAS)
Tone measurement
Secondary Outcome Measures
Mean change from baseline passive range of supination
Range of motion measurement
Mean change from baseline angle of catch (XV3) Tardieu scale
Spasticity measurement
Mean change from baseline active range of supination
Active range of motion
Full Information
NCT ID
NCT03472261
First Posted
March 14, 2018
Last Updated
April 15, 2020
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03472261
Brief Title
Integrated Management of Pronation Deformity in Cerebral Palsy
Official Title
A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, botulinum toxin-A, pronator deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patients treated by Botulinum toxin A and twister and specific home exercise program
Arm Title
Conventional Therapy Group
Arm Type
Active Comparator
Arm Description
Patients treated by Botulinum toxin A and specific home exercise program
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Dysport
Intervention Type
Other
Intervention Name(s)
Upper extremity orthoses
Intervention Description
Twister
Intervention Type
Other
Intervention Name(s)
Home exercise program
Intervention Description
Specific exercises for pronation deformity
Primary Outcome Measure Information:
Title
Mean change from baseline Modified Ashworth Scale (MAS)
Description
Tone measurement
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Mean change from baseline passive range of supination
Description
Range of motion measurement
Time Frame
Week 12
Title
Mean change from baseline angle of catch (XV3) Tardieu scale
Description
Spasticity measurement
Time Frame
Week 12
Title
Mean change from baseline active range of supination
Description
Active range of motion
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Assisting Hand Assessment (AHA)
Description
Bilateral hand use
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melike Akarsu, MSc
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41050
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Integrated Management of Pronation Deformity in Cerebral Palsy
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