Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Cerebral Palsy

February 24, 2025 updated by: Riphah International University

Effects of Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Hemiplegic Cerebral Palsy

Children with hemiplegic cerebral palsy (CP) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic CP. For the improvement of activity limitations in hemipelagic cerebral palsy children will take 20 hemiplegic cerebral palsy children with the age of 5-16 year all participants will be randomly assign and use modified Constraint induced movement therapy and virtual reality techniques.

mCIMT and Hot pack will be given to group I and unaffected hand will immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours individualized, 18-hour program of mCIMT every other day, 3 times per week during a 4-week period. Each modified CIMT session continued for 1.5 hours will give to group I on the other hand VR and Hot pack will give to group II and 18-hour VR program, every other day, 3 times per week for 4 weeks will give Each VR session continued for 1.5 hours. Then evaluate both groups on follow up.

All the data will be collected from Rising Sun Institute by using ABILHAND-KIDS questionnaire and Children's hand-use experience questionnaire. The reliability and validity of tools and mentioned.

The duration of study will be 6-months. Data will be analyzed with the help of SPSS 27

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54900
        • Recruiting
        • Rising Sun Institute
        • Contact:

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:

  • Age range between 5 to 16 years of age.
  • Medical diagnosis of spastic hemiparetic CP.
  • At least 20◦wrist and 10◦ active finger extension from full flexion.
  • More movement deficits in 1 upper extremity (less than 2.5 on the Amount of Use scale (AOU) on the Pediatric Motor Activity Log (PMAL)).
  • Muscle tone less than 3 on the Modified Ashworth Scale.
  • Normal or corrected-to-normal vision and hearing.
  • Classified level I, II, or III of the Manual Ability Classification System ( MACS) for Children with CP

Exclusion Criteria:

  • Health problems not associated with CP.
  • Seizure hemispatial neglect.
  • Orthopaedic surgery on the involved upper extremity.
  • Botulinum toxin therapy for the affected upper extremity within the past 6 months or within the study period.
  • Balance problems

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mCIMT group
Clinical experimental: For group -I mCIMT at least 5 waking hours daily for 4 weeks 3 times per week during a 4-week period.
Other: mCIMT
mCIMT+ Hot pack will be applied and unaffected hand will be immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours daily for 4 weeks and perform daily activities. Program of mCIMT every other day, 3 times per week during a 4-week period.
Active Comparator: VR Group
Clinical experimental: For group -II VR 25 minutes of VR program, every other day, 3 times per week for 4 weeks.
Other: VR
VR+ Hot pack will be applied. 25 minutes of VR program, every other day, 3 times per week for 4 weeks. Each VR session continued for 10 minutes then 5 minutes rest after that again 10 minutes VR session will do.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHEQ (Children's hand-use experience questionnaire)
Time Frame: Baseline, 4th week and 8th week
CHEQ has been developed to capture children's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet-based questionnaire containing 29 items (bimanual activities) presented one by one in random order. Test-retest reliability for the three CHEQ scale was: grasp efficacy, ICC=0.91; time taken, ICC=0.88; and feeling bothered, ICC=0.91. Total Maximum score of each component (quality, duration & psycho-status) was 100 and total maximum score of hand use was 27. Higher the results showed improvement in hand function
Baseline, 4th week and 8th week
ABILHAND-KIDS questionnaire
Time Frame: Baseline, 4th week and 8th week
ABILHAND-KIDS questionnaire is a valuable tool to assess a child's unimanual and bimanual upper limb activities. The reliability of the ABILHANDS-Kids is good across different observers as a performance- and capacity-based rating method. Test-retest reliability was 0.92. Total Maximum score was 42, mid score was 21 and minimum score was 0. Higher scores showed improvement in activity level of hand use
Baseline, 4th week and 8th week

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Maria Amjad, MS-PPT, 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)

February 15, 2025

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR/AHS/22/maria amjad

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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