Comparing the Effectiveness of mCIMT and Bimanual Training

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Bimanual Training; Other: Modified Constraint-Induced Movement Therapy

• Registration Number: NCT04577391
• Lead Sponsor: Muş Alparlan University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2018-10-15
• Primary Completion: 2020-01-15
• Study Completion: 2020-04-15
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Clinical diagnosis of spastic hemiplegic cerebral palsy
• Must be able to attend primary or secondary school

Exclusion Criteria

• Family-dependent problems interfering with participation in study sessions
• The presence of behavioral problems interfering with the assessment periods or intervention sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimanual training	Bimanual Training	BIT was administrated without any restrictive material on the non-involved upper limb, but instead, children were engaged in age-appropriate gross and fine motor bimanual activities. All targeted deficits of interest were addressed within the context of the selected activity.
Modified Constraint-Induced Movement Therapy	Modified Constraint-Induced Movement Therapy	Children's less affected hand was restricted through a mitt with a material sewn shut on the palmar face to promote the use of involved side as maximum as possible. Besides, if the participant attempted to use his/her less affected hand as an assistive, a bandage was also used to strap less affected upper limb to the trunk. Specific activities were selected according to deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request (e.g., drawing, painting, and eating). 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 the role of the child's dominant hand.

Primary Outcome Measures

Name	Time	Method
Change from baseline in manual ability on ABILHAND-Kids at 16 weeks	Baseline and week 16	ABILHAND-Kids is developed for children with cerebral palsy and measures a child's ability to manage 21 daily activities that require the use of the upper limbs. It measures the children's typical performance in daily life. ABILHAND-Kids is useful in reporting the functional performance of children with one affected side in the perspective of manual ability and has excellent test-retest reliability for Turkish children with cerebral palsy (ICC=0. 0.98)
Change from baseline in unimanual capacity on Upper Extremity Skills Test (QUEST) at 16 weeks	Baseline and week 16	The Upper Extremity Skills Test (QUEST) is a criterion-referenced measurement tool, developed to evaluate upper extremity quality of movement in children with cerebral palsy.The Upper Extremity Skills Test has been validated for children with cerebral palsy aged 18 months to 12 years. Intra-rater reliability of the QUEST has been indicated to strong (ICC=0.96) in children with cerebral palsy aged eight and over.

Trial Locations

Locations (1)

Mus Alparslan University; 🇹🇷 Mus, Muş, Turkey