NCT04577391

Comparing the Effectiveness of mCIMT and Bimanual Training

Comparing the Effects of Modified Constraint-Induced Movement Therapy and Bimanual Training in Children With Hemiplegic Cerebral Palsy Mainstreamed in Regular School: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Muş Alparslan University · Academic / Other
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Accepted

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).

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	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 involved side's use, and unimanual gross and fine motor activities were practiced with the more affected hand. 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 the 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).
OTHER	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.

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-01-15
• Completion: 2020-04-15
• First posted: 2020-10-06
• Last updated: 2021-03-09

Locations

1 site across 1 country: Turkey (Türkiye)