NCT06240988

Brief Summary

Cerebral Palsy (CP) is a major cause of motor disability in children. Among these CP children, approximately one third have hemiparetic cerebral palsy. Hemiparetic cerebral palsy is more impairment of one side of the body as a result of non-progressive disturbances in premature brain.To determine the effects of implementing a practice period of modified constraint induced movement therapy in a virtual environment on hand function in chidren with hemiparetic cerebral palsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

MCIMT, Motor Imagery Technique, Hemiparetic CP, RCT

Outcome Measures

Primary Outcomes (1)

  • QUEST (Quality of Upper Extremity Skills Test)

    Item The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid. The purpose of the QUEST is to evaluate quality of upper extremity function in four domains: dissociated movement,grasp,protective extension, and weight bearing. Scores of 1 or 2, determined by quality of assessed position or movement; 1 if movement quality is not achieved, 2 if movement quality is achieved. Item scores are summed; formulas are used to calculate percentages for each domain. Domain percentages are summed and divided by number of domains to obtain total score. Minimum score = 0, Maximum score = 100.

    8 weeks

Secondary Outcomes (1)

  • Box and Block Test (BBT)

    8 weeks

Study Arms (2)

Modified Constraint Induced Movement Therapy

EXPERIMENTAL

Group that will be provided with Modified Constraint Induced Movement Therapy. A protocol of 10 minutes of MCIMT therapy will be given including constraints.

Device: Modified Constraint Induced Movement Therapy

Motor Imagery Technique

EXPERIMENTAL

Group that will be provided with Motor Imagery Technique by grasping an object and placing it into a container, or in imagining to perform the same action.

Other: Motor Imagery Technique

Interventions

Modified Constraint Induced Movement Therapy

Modified Constraint Induced Movement Therapy

Motor Imagery Technique

Motor Imagery Technique

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 to 14 years were included.
  • Diagnosed of hemiparetic cerebral palsy and typically developing controls.
  • Both gender is included i-e, male and female.
  • Children included having motor impairments of upper limb.
  • All children had normal or corrected vision and the ability to discriminate between right and left.

You may not qualify if:

  • History of neurosensory and neuropsychiatric impairments.
  • Presence of contractures in the affected upper limb.
  • Surgery in the previous six months.
  • Uncontrolled epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • Humphreys P, Whiting S, Pham B. Hemiparetic cerebral palsy: clinical pattern and imaging in prediction of outcome. Can J Neurol Sci. 2000 Aug;27(3):210-9.

    PMID: 10975533BACKGROUND
  • Steenbergen B, Gordon AM. Activity limitation in hemiplegic cerebral palsy: evidence for disorders in motor planning. Dev Med Child Neurol. 2006 Sep;48(9):780-3. doi: 10.1017/S0012162206001666.

    PMID: 16904028BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Khansa Khalid, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be Randomized Controlled Trial in which non probability convenient sampling technique will be used. two groups of 6 to 14 years of age will be formed in which participants will be randomly divided. Group A will be given Modified CIMT and the other group B will receive motor imagery technique on upper limb in hemiparetic CP.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

February 5, 2024

Study Start

December 1, 2023

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations