Comparing the Effectiveness of mCIMT and Bimanual Training

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577391
• Other study ID #: 79236777-050.01.04
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: March 2021
• Source: Mus Alparlan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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).
• 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.

Locations

Country	Name	City	State
Turkey	Mus Alparslan University	Mus	Mus

Sponsors (1)

Lead Sponsor	Collaborator
Mus Alparlan University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Fedrizzi E, Rosa-Rizzotto M, Turconi AC, Pagliano E, Fazzi E, Pozza LV, Facchin P; GIPCI Study Group. Unimanual and bimanual intensive training in children with hemiplegic cerebral palsy and persistence in time of hand function improvement: 6-month follow — View Citation

Gelkop N, Burshtein DG, Lahav A, Brezner A, Al-Oraibi S, Ferre CL, Gordon AM. Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. Phys Occup Ther Pediatr. 2015 Feb;35( — View Citation

Sakzewski L, Ziviani J, Boyd RN. Best responders after intensive upper-limb training for children with unilateral cerebral palsy. Arch Phys Med Rehabil. 2011 Apr;92(4):578-84. doi: 10.1016/j.apmr.2010.12.003. — View Citation

Thompson AM, Chow S, Vey C, Lloyd M. Constraint-induced movement therapy in children aged 5 to 9 years with cerebral palsy: a day camp model. Pediatr Phys Ther. 2015 Spring;27(1):72-80. doi: 10.1097/PEP.0000000000000111. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in unimanual capacity on Upper Extremity Skills Test (QUEST) at 16 weeks	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.	Baseline and week 16
Primary	Change from baseline in manual ability on ABILHAND-Kids at 16 weeks	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)	Baseline and week 16