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

NCT ID: NCT04425980

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-02-15

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

Conditions

Hemiplegia; Congenital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Modified Constraint-Induced Movement Therapy

Intervention Type: OTHER

intensive use of more affected arm in structured setting

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

Group Type: ACTIVE_COMPARATOR

Modified Constraint-Induced Movement Therapy

Intervention Type: OTHER

intensive use of more affected arm in structured setting

Interventions

Modified Constraint-Induced Movement Therapy

intensive use of more affected arm in structured setting

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Cerebral palsy dependent severe emotional difficulties

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Muş Alparslan University

OTHER

Sponsor Role: lead

Responsible Party

Hasan Bingöl

Academician (Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Bingöl, MSc

Role: PRINCIPAL_INVESTIGATOR

Muş Alparslan University

Mintaze Kerem Günel, PhD

Role: STUDY_CHAIR

Hacettepe University

Halil ALKAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Muş Alparslan University

Locations

Mus Alparslan University

Muş, Muş, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

no any sponsor

Identifier Type: -

Identifier Source: org_study_id