Clinical trial NCT04211623: CIMT and BIMT Affect Functional Outcome in CP
Official title: Comparison of Constrained Induced Movement Therapy and Bimanual Intensive Movement Therapy on Functional Outcome of Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Congenital
Keywords: Cerebral Palsy
Neurorehabilitation
Spasticity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to determine the effects of constraint induced movement therapy CIMT and BIM bimanual activities on functional outcome in hemiplegic CP. Two randomized groups of patients with CP are treated with constrained arm for three hours on affected side and bimanual activities on BIM group respectively. Both, male and female patients meeting the inclusion criteria will be included. Patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded.

Detailed description: It is a Randomized control trial. Cerebral palsy children of age groups of 5 yrs to 12 years were included in the study with total sample size of thirty eight (38) with confidence interval of 95%. Simple random sampling was done by lottery method and data was collected from ALFARABI special school of education Islamabad. Two groups were formed and named as group A; CIMT with nineteen participants and group B, BIM bimanual training with nineteen participants respectively. The RCT compared the functional outcome of 3 hours constraining for 3 times a week for 6 weeks duration for CIMT group and five bimanual activities performed for three hours a day for bimanual group B and were assessed on the pretest and post test score evaluation of QUEST and JTHF test. All the participants were hemiplegic cp from both gender, fall on MAC system level II. Treatment for three hours was done on alternate days for 3 days a week. Five bimanual activites of holding a tray, cutting a fruit with knife, buttoning, cutting paper with scissor, and carry heavy objects with both hands are applied. Whereas the activities performed in CIMT are brushing teeth, holding spoon, fork combing hair and writing. Forty five children were screened before the evaluation and as a result 38 were enrolled in both groups having 19 in each group.

Eligibility criteria: Inclusion Criteria:

* Patients with age group of 5-12 years. Patients with hemiplegic cerebral palsy of both genders. Patients who have active wrist extension, active PIP -MCP joint extension and active thumb extension.

Patients who have mild spasticity on spasticity rating scale of QUEST test Patients who fall on level II on MAC System are included Patients who has cognitive dysfunction ( screening by WISC Wechsler Intelligence test for children) all have score above 80.

Exclusion Criteria:

* Patients who can develop any sort of behavior problems Patients who does not co-operate with therapist in CIMT procedure Any structural deformity. Any surgical intervention that requires patient to be immobile.

Primary outcomes:
measure: Quality of upper extremity skills test
timeFrame: 6 weeks
measure: JEBSEN Hand Function Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Manual ability classification
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Mir Arif Hussain, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
citation: Charles J, Gordon AM. A critical review of constraint-induced movement therapy and forced use in children with hemiplegia. Neural Plast. 2005;12(2-3):245-61; discussion 263-72. doi: 10.1155/NP.2005.245.
citation: Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
citation: Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.
citation: Dickerson AE, Brown LE. Pediatric constraint-induced movement therapy in a young child with minimal active arm movement. Am J Occup Ther. 2007 Sep-Oct;61(5):563-73. doi: 10.5014/ajot.61.5.563.
citation: Geerdink Y, Lindeboom R, de Wolf S, Steenbergen B, Geurts AC, Aarts P. Assessment of upper limb capacity in children with unilateral cerebral palsy: construct validity of a Rasch-reduced Modified House Classification. Dev Med Child Neurol. 2014 Jun;56(6):580-6. doi: 10.1111/dmcn.12395. Epub 2014 Feb 11.
citation: Dong VA, Tung IH, Siu HW, Fong KN. Studies comparing the efficacy of constraint-induced movement therapy and bimanual training in children with unilateral cerebral palsy: a systematic review. Dev Neurorehabil. 2013;16(2):133-43. doi: 10.3109/17518423.2012.702136. Epub 2012 Sep 4.
citation: Obladen M. Lame from birth: early concepts of cerebral palsy. J Child Neurol. 2011 Feb;26(2):248-56. doi: 10.1177/0883073810383173. Epub 2010 Dec 30.
citation: Rosenbaum P, Stewart D. The World Health Organization International Classification of Functioning, Disability, and Health: a model to guide clinical thinking, practice and research in the field of cerebral palsy. Semin Pediatr Neurol. 2004 Mar;11(1):5-10. doi: 10.1016/j.spen.2004.01.002.
citation: Utley A, Steenbergen B, Sugden DA. The influence of object size on discrete bimanual co-ordination in children with hemiplegic cerebral palsy. Disabil Rehabil. 2004 May 20;26(10):603-13. doi: 10.1080/09638280410001696674.
citation: de Brito Brandao M, Mancini MC, Vaz DV, Pereira de Melo AP, Fonseca ST. Adapted version of constraint-induced movement therapy promotes functioning in children with cerebral palsy: a randomized controlled trial. Clin Rehabil. 2010 Jul;24(7):639-47. doi: 10.1177/0269215510367974. Epub 2010 Jun 8.
citation: Wittenberg GF, Schaechter JD. The neural basis of constraint-induced movement therapy. Curr Opin Neurol. 2009 Dec;22(6):582-8. doi: 10.1097/WCO.0b013e3283320229.