Comparison of CIMT and Its Modified Form on Upper Motor Function Outcomes in Hemiplegic Cerebral Palsy.
CIMT
Comparison of Constraint-induced Movement Therapy and Its Modified Form on Upper Motor Function Outcomes and Psychosocial Impact in Hemiplegic Cerebral Palsy.
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this research is to compare the effect of classic constraint-induced movement therapy and its modified form on upper extremity motor function outcomes and psychosocial impact in hemiplegic cerebral palsy. Randomized controlled trials with 2-3 weeks follow-up. The sample size is 40. The subjects are divided in two groups, 20 subjects in classical CIMT group and 20 in modified CIMT group. Study duration is of 6 months. Sampling technique applied will be purposive non probability sampling technique. Only 4-12 years individual with hemiplegic cerebral palsy are included. Tools used in the study are Box and Block test, Cerebral palsy (quality of life), Kid Screen 27 and QUEST (quality of upper extremity skill test). Data will be analyzed through SPSS 21.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedAugust 8, 2019
August 1, 2019
4 months
September 14, 2018
August 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline [Box And Block Test (BBT)] at 3rd week
The Box and Blocks Test (BBT) is a functional test used in upper limb rehabilitation.The test is used to measure the gross manual dexterity of a patient.The test consists of a box with a partition in the middle. Blocks are placed at one side of the partition. The box is placed at a table. The test subject is seated, facing towards the box. During the tests the test subject is given 60 seconds to move as many blocks as possible from one side to the other, by using only his tested hand. The number of displaced blocks is a measure of the gross manual dexterity. A higher number of displaced blocks indicates a better gross dexterity.
3rd week
Secondary Outcomes (3)
Change from Baseline [Quality Of Upper Extremity Skill Test (QUEST)] at 3rd week
3 weeks.
Change from Baseline [Kid Screen 27] at 3rd week
3 weeks.
Change from Baseline [Cerebral Palsy Quality of Life CP(QOL)] at 3rd week
3 weeks.
Study Arms (2)
Classic CIMT group
ACTIVE COMPARATORTotal session of 6 hours a day, 5 days per week for 3 weeks to Classic CIMT groups will be given.
mCIMT group
EXPERIMENTALSession of 6 hours a day, 5 session per week for first 2 weeks (CIMT), session of 2 hours a day, 5 days per week for last 1 week (BIT) to modified CIMT group will be given.
Interventions
Constraint Induced Movement Therapy (CIMT) is a new treatment technique that claims to improve the arm motor ability and the functional use of a paretic arm - hand. CIMT forces the use of the affected side by restraining the unaffected side. Child with hemiplegic cerebral palsy can learn to improve the motor ability of the more affected parts of their bodies and thus cease to rely exclusively or primarily on the less affected parts.
Modified CIMT protocol that was based on suggestions made by Dromerick, Edwards, and Hahn (2000) . Modifications were reductions in the duration of mitt wear and massed practice compared with the traditional protocol
Eligibility Criteria
You may qualify if:
- to 12 years CP with unilateral, bilateral or severely asymmetrical impairment Manual Ability Classification System(MACS) I, II or III
- Wrist extension capacity at least 20°; fingers with 10° of complete flexion
- Children able to follow Command
You may not qualify if:
- Children also having disabilities other than Cerebral palsy
- Contractures that significantly limit functional arm use.
- Children with MR.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riphah International University
Islamabad, Federal, 44000, Pakistan
Related Publications (16)
Maenner MJ, Blumberg SJ, Kogan MD, Christensen D, Yeargin-Allsopp M, Schieve LA. Prevalence of cerebral palsy and intellectual disability among children identified in two U.S. National Surveys, 2011-2013. Ann Epidemiol. 2016 Mar;26(3):222-6. doi: 10.1016/j.annepidem.2016.01.001. Epub 2016 Jan 12.
PMID: 26851824BACKGROUNDWinter S, Autry A, Boyle C, Yeargin-Allsopp M. Trends in the prevalence of cerebral palsy in a population-based study. Pediatrics. 2002 Dec;110(6):1220-5. doi: 10.1542/peds.110.6.1220.
PMID: 12456922BACKGROUNDHimmelmann K, Beckung E, Hagberg G, Uvebrant P. Gross and fine motor function and accompanying impairments in cerebral palsy. Dev Med Child Neurol. 2006 Jun;48(6):417-23. doi: 10.1017/S0012162206000922.
PMID: 16700930BACKGROUNDReddihough D. Cerebral palsy in childhood. Aust Fam Physician. 2011 Apr;40(4):192-6.
PMID: 21597527BACKGROUNDAl-Oraibi S, Eliasson AC. Implementation of constraint-induced movement therapy for young children with unilateral cerebral palsy in Jordan: a home-based model. Disabil Rehabil. 2011;33(21-22):2006-12. doi: 10.3109/09638288.2011.555594. Epub 2011 Feb 18.
PMID: 21332299BACKGROUNDFacchin P, Rosa-Rizzotto M, Visona Dalla Pozza L, Turconi AC, Pagliano E, Signorini S, Tornetta L, Trabacca A, Fedrizzi E; GIPCI Study Group. Multisite trial comparing the efficacy of constraint-induced movement therapy with that of bimanual intensive training in children with hemiplegic cerebral palsy: postintervention results. Am J Phys Med Rehabil. 2011 Jul;90(7):539-53. doi: 10.1097/PHM.0b013e3182247076.
PMID: 21765273BACKGROUNDSakzewski 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.
PMID: 19451190BACKGROUNDNovak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
PMID: 23962350BACKGROUNDHoare B, Imms C, Carey L, Wasiak J. Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy: a Cochrane systematic review. Clin Rehabil. 2007 Aug;21(8):675-85. doi: 10.1177/0269215507080783.
PMID: 17846067BACKGROUNDEliasson AC, Krumlinde-sundholm L, Shaw K, Wang C. Effects of constraint-induced movement therapy in young children with hemiplegic cerebral palsy: an adapted model. Dev Med Child Neurol. 2005 Apr;47(4):266-75. doi: 10.1017/s0012162205000502.
PMID: 15832550BACKGROUNDTinderholt Myrhaug H, Ostensjo S, Larun L, Odgaard-Jensen J, Jahnsen R. Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis. BMC Pediatr. 2014 Dec 5;14:292. doi: 10.1186/s12887-014-0292-5.
PMID: 25475608BACKGROUNDde Brito Brandao M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622.
PMID: 23106987BACKGROUNDDeppe W, Thuemmler K, Fleischer J, Berger C, Meyer S, Wiedemann B. Modified constraint-induced movement therapy versus intensive bimanual training for children with hemiplegia - a randomized controlled trial. Clin Rehabil. 2013 Oct;27(10):909-20. doi: 10.1177/0269215513483764. Epub 2013 Jul 1.
PMID: 23818409BACKGROUNDGordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.
PMID: 21700924BACKGROUNDAarts PB, Jongerius PH, Geerdink YA, van Limbeek J, Geurts AC. Effectiveness of modified constraint-induced movement therapy in children with unilateral spastic cerebral palsy: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Jul-Aug;24(6):509-18. doi: 10.1177/1545968309359767. Epub 2010 Apr 27.
PMID: 20424191BACKGROUNDSakzewski L, Carlon S, Shields N, Ziviani J, Ware RS, Boyd RN. Impact of intensive upper limb rehabilitation on quality of life: a randomized trial in children with unilateral cerebral palsy. Dev Med Child Neurol. 2012 May;54(5):415-23. doi: 10.1111/j.1469-8749.2012.04272.x. Epub 2012 Mar 17.
PMID: 22429002BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Imran Amjad, PHD
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2018
First Posted
October 1, 2018
Study Start
October 15, 2018
Primary Completion
February 10, 2019
Study Completion
March 1, 2019
Last Updated
August 8, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share