NCT03691506

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

September 14, 2018

Last Update Submit

August 7, 2019

Conditions

Keywords

Cerebral PalsyConstraint-Induced Movement Therapy

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 COMPARATOR

Total session of 6 hours a day, 5 days per week for 3 weeks to Classic CIMT groups will be given.

Other: Classic CIMT group

mCIMT group

EXPERIMENTAL

Session 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.

Other: Modified CIMT group

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.

Classic CIMT group

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

mCIMT group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

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: 26851824BACKGROUND
  • Winter 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: 12456922BACKGROUND
  • Himmelmann 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: 16700930BACKGROUND
  • Reddihough D. Cerebral palsy in childhood. Aust Fam Physician. 2011 Apr;40(4):192-6.

    PMID: 21597527BACKGROUND
  • Al-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: 21332299BACKGROUND
  • Facchin 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: 21765273BACKGROUND
  • 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.

    PMID: 19451190BACKGROUND
  • Novak 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: 23962350BACKGROUND
  • Hoare 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: 17846067BACKGROUND
  • Eliasson 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: 15832550BACKGROUND
  • Tinderholt 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: 25475608BACKGROUND
  • de 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: 23106987BACKGROUND
  • Deppe 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: 23818409BACKGROUND
  • Gordon 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: 21700924BACKGROUND
  • Aarts 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: 20424191BACKGROUND
  • Sakzewski 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

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Imran Amjad, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

Locations