Comparing the Effectiveness of mCIMT and Bimanual Training

Muş Alparlan University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Bimanual Training; Other: Modified Constraint-Induced Movement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04577391

79236777-050.01.04

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Modified Constraint-Induced Movement Therapy

Experimental group

Description:

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.

Treatment:

Other: Modified Constraint-Induced Movement Therapy

Bimanual training

Active Comparator group

Description:

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.

Treatment:

Other: Bimanual Training