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

Sponsor

Muş Alparlan University (Other)

Overall Status

Completed

CT.gov ID

NCT04425980

Collaborator

(none)

Enrollment

Location

Arms

16.5

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia; Congenital	Other: Modified Constraint-Induced Movement Therapy	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 probabilitya 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:

Single (Participant)

Masking Description:

by concealing the other allocated intervention from participants / unaware of the presence of a second intervention approach

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Jul 15, 2019

Actual Study Completion Date :

Feb 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Modified Constraint-Induced Movement Therapy (test treatments) 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	Other: Modified Constraint-Induced Movement Therapy intensive use of more affected arm in structured setting
Active Comparator: Bimanual training 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	Other: Modified Constraint-Induced Movement Therapy intensive use of more affected arm in structured setting

Arm

Intervention/Treatment

Experimental: Modified Constraint-Induced Movement Therapy (test treatments)

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

Other: Modified Constraint-Induced Movement Therapy

intensive use of more affected arm in structured setting

Active Comparator: Bimanual training

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

Other: Modified Constraint-Induced Movement Therapy

intensive use of more affected arm in structured setting

Outcome Measures

Primary Outcome Measures

Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention [From baeline to post-intervention, up to 16 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Cerebral palsy dependent severe emotional difficulties

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mus Alparslan University	Mus	Muş	Turkey	49100

Sponsors and Collaborators

Muş Alparlan University

Investigators

Principal Investigator: Hasan Bingöl, MSc, Mus Alparslan University
Study Chair: Mintaze Kerem Günel, PhD, Hacettepe University
Principal Investigator: Halil ALKAN, PhD, Mus Alparslan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hasan Bingöl, Academician (Lecturer, Muş Alparlan University

ClinicalTrials.gov Identifier:

NCT04425980

Other Study ID Numbers:

no any sponsor

First Posted:

Jun 11, 2020

Last Update Posted:

Mar 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemiplegia

Study Results

No Results Posted as of Mar 9, 2021