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The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia

Primary Purpose

Hemiplegia; Congenital

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Modified Constraint-Induced Movement Therapy
Sponsored by
Muş Alparlan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia; Congenital

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of congenital hemiplegia,
  • Must be able to grasp objects

Exclusion Criteria:

  • Cerebral palsy dependent severe emotional difficulties

Sites / Locations

  • Mus Alparslan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Constraint-Induced Movement Therapy (test treatments)

Bimanual training

Arm Description

A list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook a role as a dominant hand

For the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities

Outcomes

Primary Outcome Measures

Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention
The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents

Secondary Outcome Measures

Full Information

First Posted
June 5, 2020
Last Updated
March 5, 2021
Sponsor
Muş Alparlan University
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1. Study Identification

Unique Protocol Identification Number
NCT04425980
Brief Title
The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia
Official Title
The Efficacy of Two Models of Intensive Upper Limb Training On Quality of Life in Children With Hemiplegic Cerebral Palsy Attending Regular School in Mus Province: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muş Alparlan 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
This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy
Detailed Description
A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period. During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia; Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or Bimanual training), at an equal number and probability
Masking
Participant
Masking Description
by concealing the other allocated intervention from participants / unaware of the presence of a second intervention approach
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Constraint-Induced Movement Therapy (test treatments)
Arm Type
Experimental
Arm Description
A list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook a role as a dominant hand
Arm Title
Bimanual training
Arm Type
Active Comparator
Arm Description
For the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities
Intervention Type
Other
Intervention Name(s)
Modified Constraint-Induced Movement Therapy
Intervention Description
intensive use of more affected arm in structured setting
Primary Outcome Measure Information:
Title
Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention
Description
The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents
Time Frame
From baeline to post-intervention, up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of congenital hemiplegia, Must be able to grasp objects Exclusion Criteria: Cerebral palsy dependent severe emotional difficulties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Bingöl, MSc
Organizational Affiliation
Mus Alparslan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mintaze Kerem Günel, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Halil ALKAN, PhD
Organizational Affiliation
Mus Alparslan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mus Alparslan University
City
Mus
State/Province
Muş
ZIP/Postal Code
49100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia

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