Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP (CIMT)

August 26, 2023 updated by: Mamoona Tasleem Afzal, Health Education Research Foundation (HERF)

Effects of Classic Constraint Induced Movement Therapy and Its Modified Form on Quality of Life of Children With Hemiplegic Cerebral Palsy

The purpose of this research is to see the effect of classic constraint-induced movement therapy and its modified form on quality of life of children with 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 Cerebral palsy (quality of life) and Kid Screen 27.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Both CCIMT and MCIMT are effective treatments to improve quality of life of children with CP. However conflicting evidence is present on which one of these is more effective and no final conclusion can be made to date. This study intends to add to the literature and contribute in reaching final conclusion about the superiority of either intervention. The purpose of this study was to see the psychosocial effect (quality of life) of CIMT and its modified form on HCP

Study Type

Interventional

Enrollment (Actual)

40

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, 45400
        • Yusra Institute of Rehablitation Science

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 4 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

Exclusion Criteria:

  • Children also having disabilities other than Cerebral palsy Contractures that significantly limit functional arm use. Children with MR

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Classic CIMT group
Total session of 6 hours a day, 5 days per week for 3 weeks to Classic CIMT groups will be given.
Other: modified constraint induced movement therapy
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
Other Names:
  • classic constaint induced movement therapy
Experimental: mCIMT group
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 constraint induced movement therapy
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
Other Names:
  • classic constaint induced movement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Palsy Quality of Life CP(QOL)
Time Frame: 3 weeks.
The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the first health condition-specific questionnaire designed for measuring QOL in children with cerebral palsy (CP) aged 4-12 years. CP QOL Questionnaires measure include : Social wellbeing & acceptance, Feelings about functioning, Participation & physical health, Emotional wellbeing & self-esteem, Access to services, Pain & impact of disability, Family health
3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kid Screen 27
Time Frame: 3 weeks
The KIDSCREEN-27 was developed as a shorter version of the KIDSCREEN-52 with a minimum of information loss and with good psychometric properties. The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items)
3 weeks

Collaborators and Investigators

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

Sponsor

Health Education Research Foundation (HERF)

Investigators

  • Principal Investigator: Saad Tariq, master, Riphah International University

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)

October 1, 2018

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

August 26, 2023

First Submitted That Met QC Criteria

August 26, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YIRS/007

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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