CIMT and BIMT Affect Functional Outcome in CP

December 23, 2019 updated by: Riphah International University

Comparison of Constrained Induced Movement Therapy and Bimanual Intensive Movement Therapy on Functional Outcome of Hemiplegic Cerebral Palsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Constraint induced movement therapy group
Constrained on more affected side for three hours.
Other: 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
Active Comparator: Bimanual activities group; BIM training
Set of bimanual activities performed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of upper extremity skills test
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual ability classification
Time Frame: 6 weeks
The Manual Ability Classification System (MACS) describes how children with (CP) use their hands to carry objects in daily routine. MAC describes 5 levels. These levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. The MACS also describe differences between adjacent levels to make it easier to determine which level best corresponds with the child's capability to handle objects. The objects are relevant and age-appropriate for the children, used when they perform tasks such as eating, dressing, playing, drawing or writing. Etc.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiphahIUHumaile

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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