Mirror Therapy on Hand Function in Cerebral Palsy
Primary Purpose
Hemiplegic Cerebral Palsy, Mirror Hands
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Physical therapy exercises
Mirror therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Mirror therapy, Hand function, Grip strength
Eligibility Criteria
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
Sites / Locations
- Batterjee Medical College
- Local physical rehabilitation centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Study
Arm Description
A traditional physical therapy program
Mirror therapy plus traditional physical therapy program
Outcomes
Primary Outcome Measures
Hand grip strength
Change of hand strength by using Hand Dynamometer
Hand function
Change of hand function skills by using Box and block test
Secondary Outcome Measures
Full Information
NCT ID
NCT05396053
First Posted
May 25, 2022
Last Updated
December 8, 2022
Sponsor
Batterjee Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05396053
Brief Title
Mirror Therapy on Hand Function in Cerebral Palsy
Official Title
Mirror Therapy Improves Hand Strength and Function in Children With Unilateral Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batterjee Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy, Mirror Hands
Keywords
Mirror therapy, Hand function, Grip strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study and control
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
A traditional physical therapy program
Arm Title
Study
Arm Type
Experimental
Arm Description
Mirror therapy plus traditional physical therapy program
Intervention Type
Other
Intervention Name(s)
Physical therapy exercises
Intervention Description
Three times a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
Three times a week for 8 weeks.
Primary Outcome Measure Information:
Title
Hand grip strength
Description
Change of hand strength by using Hand Dynamometer
Time Frame
8 weeks
Title
Hand function
Description
Change of hand function skills by using Box and block test
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Abdel Ghafar, Ph.D
Organizational Affiliation
Batterjee Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Batterjee Medical College
City
Jeddah
Country
Saudi Arabia
Facility Name
Local physical rehabilitation centers
City
Jeddah
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Mirror Therapy on Hand Function in Cerebral Palsy
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