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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06082115
Other study ID # P.T.REC/012/004452
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date January 20, 2024

Study information

Verified date October 2023
Source Beni-Suef University
Contact Eman Wagdy
Phone 01008079576
Email Eman.wagdy@pt.bsu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the effect between mirror therapy and task-oriented training on hand function in children with unilateral cerebral palsy.


Description:

Dysfunction in the upper limbs and hand function is one of the most common symptoms in children with cerebral palsy (CP), particularly children with unilateral CP which intern has the potential to limit the involvement of these children in life activities and cause distress and suffering for both children and their parents. Different rehabilitation intervention procedures addressing upper extremity dysfunction are essential to promote better use of disabled arms and hands in daily activities and achieving functional independence at home, in school and in the community. However, there is little evidence directed toward which intervention procedure is more effective on hand function therefore, there is need to compare between the functional outcome of mirror therapy versus task-oriented training on hand function in children with unilateral cerebral palsy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date January 20, 2024
Est. primary completion date January 20, 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 8 Years
Eligibility Inclusion Criteria: 1. Children ages will be ranged from 5 to 8 years old. 2. Wrist flexor spasticity ranged from grade 1 to 1+ according to Modified Aswarth scale. 3. Capacity to handle objects without continuous assistance (level I or II in accordance with the Manual Ability Classification System). 4. Ability to sit alone. 5. Sufficient cognition to follow simple verbal instructions. Exclusion Criteria: 1. Fixed contracture or deformities in the upper limb. 2. Visual or auditory defects. 3. Botulinuim toxin injection in the last 6 months before the study. 4. Previous surgical intervention in the upper limb.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Selected Physical and Occupational Therapy Program
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.
Mirror Therapy
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).
Task-Oriented Training
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Outcome

Type Measure Description Time frame Safety issue
Primary Grip Strength 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 Range of Motion 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
Secondary Upper Extremity Skills 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
Secondary Hand Dexetrity 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
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