- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06082115
Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
Functional Outcome of Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eman Wagdy
- Phone Number: 01008079576
- Email: Eman.wagdy@pt.bsu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children ages will be ranged from 5 to 8 years old.
- Wrist flexor spasticity ranged from grade 1 to 1+ according to Modified Aswarth scale.
- Capacity to handle objects without continuous assistance (level I or II in accordance with the Manual Ability Classification System).
- Ability to sit alone.
- Sufficient cognition to follow simple verbal instructions.
Exclusion Criteria:
- Fixed contracture or deformities in the upper limb.
- Visual or auditory defects.
- Botulinuim toxin injection in the last 6 months before the study.
- Previous surgical intervention in the upper limb.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Selected Physical and Occupational Therapy Program
Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour.
The duration of treatment will be 3 times/week for 12 weeks.
|
The selected physical and occupational therapy program include:- A-Physical therapy program contains neurodevelopmental technique for U.L & L.L (U.L & L.L approximation, U.L & L.L weight bearing exercises), stretching exercises for U.L & L.L muscles, strengthening exercises for antispastic group of U.L & L.L muscles, facilitation of postural reactions, facilitation of gait training and, ascending and descending stairs. B-Occupational therapy program contains transfer cube from one hand to hand, reaching to mouth (eating lollipop), throwing and catching ball and, clapping with both hands. |
|
Experimental: Mirror Therapy
Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to mirror therapy for 30 minutes.
The duration of treatment will be 3 times/week for 12 weeks.
|
The selected physical and occupational therapy program include:- A-Physical therapy program contains neurodevelopmental technique for U.L & L.L (U.L & L.L approximation, U.L & L.L weight bearing exercises), stretching exercises for U.L & L.L muscles, strengthening exercises for antispastic group of U.L & L.L muscles, facilitation of postural reactions, facilitation of gait training and, ascending and descending stairs. B-Occupational therapy program contains transfer cube from one hand to hand, reaching to mouth (eating lollipop), throwing and catching ball and, clapping with both hands.
The mirror therapy program include tasks of manipulative and grasping skills that performed by the non-affected hand in-front of mirror while the affected hand behind the mirror.
These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes).
|
|
Experimental: Task Oriented Training
Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to task oriented training for 30 minutes.
The duration of treatment will be 3 times/week for 12 weeks.
|
The selected physical and occupational therapy program include:- A-Physical therapy program contains neurodevelopmental technique for U.L & L.L (U.L & L.L approximation, U.L & L.L weight bearing exercises), stretching exercises for U.L & L.L muscles, strengthening exercises for antispastic group of U.L & L.L muscles, facilitation of postural reactions, facilitation of gait training and, ascending and descending stairs. B-Occupational therapy program contains transfer cube from one hand to hand, reaching to mouth (eating lollipop), throwing and catching ball and, clapping with both hands.
The task-oriented training program include tasks of manipulative and grasping skills that performed by the affected hand based on repetition practice.
These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip Strength
Time Frame: Up to 12 weeks
|
Hand-held dynamometer will be used to measure hand grip strength.
It is a valid and reliable device used to measure isometric grip strength.
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: Up to 12 weeks
|
Electronic(digital) goniometer will be used for measuring wrist extension ROM.
It is a valid and reliable tool used to assess wrist extension ROM
|
Up to 12 weeks
|
|
Upper Extremity Skills
Time Frame: Up to 12 weeks
|
Quality Upper Extremity Skill Test (QUEST) will be used to evaluate movement pattern and and function.
It is a valid scale contains 4 domains (33 items); Dissociated movements (19 items), Grasp (6 items), Weight bearing (5 items) and Protective extension (3 items).
The total testing time including administration and scoring is approximately 45 minutes.
|
Up to 12 weeks
|
|
Hand Dexetrity
Time Frame: Up to 12 weeks
|
Box and Block Test (BBT) will be used for measuring hand dexterity by using two compartment box containing 150 blocks.
The test includes grasping, moving, and releasing wooden blocks from one side to the other.
The score was recorded for 1 minute as the number of blocks passed over the wooden partition
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004452
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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