Clinical trial NCT04577391: Comparing the Effectiveness of mCIMT and Bimanual Training
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: upper limb
hand
bimanual training
constraint-induced movement therapy
ICF-CY
hemiplegic cerebral palsy
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in unimanual capacity on Upper Extremity Skills Test (QUEST) at 16 weeks
timeFrame: Baseline and week 16
measure: Change from baseline in manual ability on ABILHAND-Kids at 16 weeks
timeFrame: Baseline and week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Mus
country: Turkey
facility: Mus Alparslan University
state: Muş
Study officials:
affiliation: Muş Alparslan University
name: Hasan Bingöl, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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(1):24-39. doi: 10.3109/01942638.2014.925027. Epub 2014 Jul 1.
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.
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.
citation: 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.