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CIMT and BIMT Affect Functional Outcome in CP

NCT ID: NCT04211623

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy, Congenital

Keywords

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Cerebral Palsy Neurorehabilitation Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Constraint induced movement therapy group

Constrained on more affected side for three hours.

Group Type ACTIVE_COMPARATOR

Constraint induced movement therapy

Intervention Type OTHER

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

Bimanual activities group; BIM training

Set of bimanual activities performed.

Group Type ACTIVE_COMPARATOR

Bimanual activities

Intervention Type OTHER

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.

Interventions

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Constraint induced movement therapy

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

Intervention Type OTHER

Bimanual activities

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mir Arif Hussain, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 17044964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16097492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19451190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17979861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17944294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24517893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22946588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21193777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15132248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15204514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20530645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19741529 (View on PubMed)

Other Identifiers

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RiphahIUHumaile

Identifier Type: -

Identifier Source: org_study_id