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Comparing the Effects of Modified Constraint-Induced Movement Therapy and Bimanual Training in Children With Hemiplegic Cerebral Palsy Mainstreamed in Regular School: A Randomized Controlled Study
This study aimed to compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Bimanual Training (BIT) based on the International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) conceptual framework. Our assumptions were that (1) mCIMT is more effective on outcomes representing all subdomains of ICF and (2) the possible improvements in the body structure and function, activity, and participation subdomains of ICF are intimately related to each other.
Thirty-two children with spastic hemiplegic cerebral palsy (mean age 10.43 years \[SD 2.9 years\]; 15 females, 17 males) whose functional profiles associated with Manual Ability Classification System, Gross Motor Function Classification System, and Communication Function Classification System changed between level I-III were randomly distributed to one of the mCIMT or BIT groups with equivalent dosing frequency and intensity (10 weeks/3 days per week/2.5 hours per day). Outcome measures categorized according to the domains of International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) framework were used to document body functions, activity, and participation outcomes. Assessments were carried out before (T1) and after treatment (T2), and at 16 weeks post-intervention (T3) by a physical therapist blinded to group allocation. Before the study entry, informed consent was obtained from the parents. General and specific contents related to each intervention were delivered as individual sessions at the school (one session per week) or group sessions with two participants at rehabilitation centers (two sessions per week).
Age
7 - 14 years
Sex
ALL
Healthy Volunteers
Yes
Mus Alparslan University
Muş, Muş, Turkey (Türkiye)
Start Date
October 15, 2018
Primary Completion Date
January 15, 2020
Completion Date
April 15, 2020
Last Updated
March 9, 2021
32
ACTUAL participants
Modified Constraint-Induced Movement Therapy
OTHER
Bimanual Training
OTHER
Lead Sponsor
Muş Alparslan University
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07168577