- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240988
Effects of CIMT With and Without MIT on Upper Limb of Children With Hemiparetic CP
June 11, 2024 updated by: Riphah International University
Effects of Constraint Induced Movement Therapy With and Without Motor Imagery Technique on Upper Limb of Children With Hemiparetic Cerebral Palsy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.The term Modified constraint-induced movement therapy is a form of rehabilitation therapy that limits the less paretic side, and through repeated and concentrated training improve the upper limb function of the paretic side.
Motor imagery is a cognitive process in which a subject imagines that he or she performs a movement without actually performing the movement and without even tensing the muscles.
Modified Constraint induced movement therapy can be utilized in both the lower and upper extremities with the motor imagery technique for psychological or occupational therapy and in affecting which one is better for speedy recovery.
Study Type
Interventional
Enrollment (Actual)
22
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
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- 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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of neurosensory and neuropsychiatric impairments.
- Presence of contractures in the affected upper limb.
- Surgery in the previous six months.
- Uncontrolled epilepsy
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 |
|---|---|
|
Experimental: Modified Constraint Induced Movement Therapy
Group that will be provided with Modified Constraint Induced Movement Therapy.
A protocol of 10 minutes of MCIMT therapy will be given including constraints.
|
Modified Constraint Induced Movement Therapy
|
|
Experimental: Motor Imagery Technique
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.
|
Motor Imagery Technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QUEST (Quality of Upper Extremity Skills Test)
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block Test (BBT)
Time Frame: 8 weeks
|
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
It is a quick, simple and inexpensive test.
It can be used with a wide range of populations.
Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.
Score each hand separately.
Higher scores are indicative of better manual dexterity.
During the performance of the BBT, the evaluator should be aware of whether the client's fingertips are crossing the partition.
Blocks should be counted only when this condition is respected.
Furthermore, if two blocks are transferred at once, only one block will be counted.
Blocks that fall outside the box, after trespassing the partition, even if they don't make it to the other compartment, should be counted.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Khansa Khalid, MS, 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
- 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.
- 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.
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)
December 1, 2023
Primary Completion (Actual)
February 15, 2024
Study Completion (Actual)
February 15, 2024
Study Registration Dates
First Submitted
December 26, 2023
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Actual)
June 13, 2024
Last Update Submitted That Met QC Criteria
June 11, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0743
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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