- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05396053
Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy
January 6, 2024 updated by: Mohamed A. Abdel Ghafar, Batterjee Medical College
Mirror Therapy Versus CIMT Improves Hand Strength and Function in Children With Unilateral Cerebral Palsy
The aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hemiplegic cerebral palsy (HCP) is a form of paralysis that affects motor performance and muscle tone on one side of the body.
Spastic hemiplegia CP is the second form of cerebral palsy in premature infants, affecting one side of the body's limbs.
Hand and upper limb dysfunction cause problems in half of the children with cerebral palsy.
Mirror therapy is a growingly recognized new treatment option for hemiplegic cerebral palsy.
While upper extremity involvement in hemiplegic CP and the residual effects are more severe, there is limited evidence of the efficacy of mirror treatment in children with hemiplegic CP
Study Type
Interventional
Enrollment (Actual)
74
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
-
-
-
Jeddah, Saudi Arabia
- Batterjee Medical College
-
Jeddah, Saudi Arabia
- Local physical rehabilitation centers
-
-
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
5 years to 9 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Spasticity grade 1 or 1+ based on the modified Ashworth scale
- Able to understand and follow instructions
Exclusion Criteria:
- Cognitive impairment
- Orthopedic dysfunction
- Impairment in visual acuity
- Children who are unable to pay attention during the treatment period
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: Control
A traditional physical therapy program
|
Three times a week for 12 weeks.
|
|
Experimental: Study 1
Mirror therapy plus traditional physical therapy program
|
Three times a week for 12 weeks.
Three times a week for 12 weeks.
|
|
Experimental: Study 2
Constraint-induced movement therapy plus traditional
|
Three times a week for 12 weeks.
Three times a week for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand grip strength
Time Frame: 12 weeks
|
Change of hand strength by using Hand Dynamometer
|
12 weeks
|
|
Hand function
Time Frame: 12 weeks
|
Change of hand function skills by using Box and block test
|
12 weeks
|
|
Fine Motor skills
Time Frame: 12 weeks
|
Change of fine motor skills score by using Peabody
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed A Abdel Ghafar, Ph.D, Batterjee Medical College
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)
May 26, 2022
Primary Completion (Actual)
August 15, 2022
Study Completion (Actual)
October 10, 2022
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
May 25, 2022
First Posted (Actual)
May 31, 2022
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
January 6, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mirror therapy
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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