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

Sponsor
Health Education Research Foundation (HERF) (Other)
Overall Status
Completed
CT.gov ID
NCT06021899
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
3
Actual Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: modified constraint induced movement therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Classic Constraint Induced Movement Therapy and Its Modified Form on Quality of Life of Children With Hemiplegic Cerebral Palsy
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Dec 30, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral Palsy Quality of Life CP(QOL) [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

    Secondary Outcome Measures

    1. Kid Screen 27 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yusra Institute of Rehablitation Science Islamabad Pakistan 45400

    Sponsors and Collaborators

    • Health Education Research Foundation (HERF)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mamoona Tasleem Afzal, Mamoona Tasleem Afzal, Health Education Research Foundation (HERF)
    ClinicalTrials.gov Identifier:
    NCT06021899
    Other Study ID Numbers:
    • YIRS/007
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mamoona Tasleem Afzal, Mamoona Tasleem Afzal, Health Education Research Foundation (HERF)
    Constraint induced movement therapy
    Cerebral palsy
    CPQOL
    Additional relevant MeSH terms:
    Cerebral Palsy

    Study Results

    No Results Posted as of Sep 1, 2023