NCT04211623

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

December 23, 2019

Last Update Submit

December 23, 2019

Conditions

Keywords

Cerebral PalsyNeurorehabilitationSpasticity

Outcome Measures

Primary Outcomes (2)

  • Quality of upper extremity skills test

    Quality of upper extremity skills test or QOL quality of life. This scoring includes dissociated movements, grasps, weight bearing and protected extension. This scoring helps the therapist to determine which functional limitations needs to be addressed for better flexion extension abduction and other related movements to improve quality of life . It includes 36 items to be tested and thirty to forty minutes to apply and assess the test.

    6 weeks

  • JEBSEN Hand Function Test

    The JEBSEN Hand Function Test was designed to provide a comprehensive, objective test of hand function for actions of daily living. It has 7 items and takes approximately 15-45 minutes to administer. 7 items include: writing, turning over 3-by-5 inch cards, picking up small common objects, stacking checkers, simulated feeding, picking up large light objects and picking up large heavy objects. The results are calculated by timing the time taken to complete each task. The tests are always presented in the same order and are performed with the non-dominant hand first

    6 weeks

Secondary Outcomes (1)

  • Manual ability classification

    6 weeks

Study Arms (2)

Constraint induced movement therapy group

ACTIVE COMPARATOR

Constrained on more affected side for three hours.

Other: Constraint induced movement therapy

Bimanual activities group; BIM training

ACTIVE COMPARATOR

Set of bimanual activities performed.

Other: Bimanual activities

Interventions

Constrained on more affected side for three hours. To minimize the learned non use in hemiplegic CIMT is applied and criteria of applying CIMT is; * 10 degrees active wrist extension on the affected hand, * 10 degrees active thumb abduction, * 10 º active extension of any two digits on the side or hand which is limited due to damage. In order to gain the maximum good results from CIMT technique following points should also be considered attentively. Affected arm should move to 45 degrees shoulder flexion and abduction, and 90 degrees of elbow flexion and extension. Constrained with cotton sling. 3 to 5 upper limb functional activities like * using fork or a spoon, * combing hair * brushing teeth * writing * dressing all activities are performed for 10 t0 15 minutes in period of three hours on alternate days in a week

Constraint induced movement therapy group

Bimanual activities of both hands are performed like Set of bimanual activities is used to assess the bimanual hand function. Five bimanual activities are performed such as * carrying a tray, * cutting a fruit with a knife, * holding and cutting the paper with scissor, * buttoning and * Carrying heavy objects with both hands. Every activity was performed for 10 t0 15 minutes on alternate days for a period of 6 weeks session.

Bimanual activities group; BIM training

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (12)

  • 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.

    PMID: 17044964BACKGROUND
  • 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.

    PMID: 16097492BACKGROUND
  • 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
  • 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.

    PMID: 17979861BACKGROUND
  • 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.

    PMID: 17944294BACKGROUND
  • 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.

    PMID: 24517893BACKGROUND
  • 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.

    PMID: 22946588BACKGROUND
  • 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.

    PMID: 21193777BACKGROUND
  • 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.

    PMID: 15132248BACKGROUND
  • 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.

    PMID: 15204514BACKGROUND
  • 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.

    PMID: 20530645BACKGROUND
  • 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.

    PMID: 19741529BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Mir Arif Hussain, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 26, 2019

Study Start

March 1, 2019

Primary Completion

June 30, 2019

Study Completion

July 31, 2019

Last Updated

December 26, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations