Comparing the Effectiveness of mCIMT and Bimanual Training

NCT04577391 | Completed

• 1 other identifier: 79236777-050.01.04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

upper limb; hand; bimanual training; constraint-induced movement therapy; ICF-CY; hemiplegic cerebral palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Modified Constraint-Induced Movement Therapy

EXPERIMENTAL

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.

Other: Modified Constraint-Induced Movement Therapy

Bimanual training

ACTIVE COMPARATOR

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.

Other: Bimanual Training

Interventions

Modified Constraint-Induced Movement Therapy OTHER

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).

Modified Constraint-Induced Movement Therapy

Bimanual Training OTHER

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.

Bimanual training

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Mus Alparslan University

Muş, Muş, 49100, Turkey (Türkiye)

Location

Related Publications (5)

• 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-up results of a multisite clinical trial. J Child Neurol. 2013 Feb;28(2):161-75. doi: 10.1177/0883073812443004. Epub 2012 May 10.

  PMID: 22580904 RESULT

• 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(1):24-39. doi: 10.3109/01942638.2014.925027. Epub 2014 Jul 1.

  PMID: 24983295 RESULT

• 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.

  PMID: 21440702 RESULT

• 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.

  PMID: 25521268 RESULT

• Bingol H, Gunel MK. 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. Arch Pediatr. 2022 Feb;29(2):105-115. doi: 10.1016/j.arcped.2021.11.017. Epub 2022 Jan 14.

  PMID: 35039189 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hasan Bingöl, MSc

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor was masked to group allocation/ participants were blinded to the presence of two different intervention approaches
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician (Lecturer

Model Details: Randomized controlled trial: Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 6, 2020
• Study Start: October 15, 2018
• Primary Completion: January 15, 2020
• Study Completion: April 15, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)