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Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy

Primary Purpose

Unilateral Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Selected Physical and Occupational Therapy Program
Mirror Therapy
Task-Oriented Training
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Cerebral Palsy focused on measuring Mirror Therapy, Task Oriented Training, Hand Function, Unilateral Cerebral Palsy

Eligibility Criteria

5 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Selected Physical and Occupational Therapy Program

    Mirror Therapy

    Task Oriented Training

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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.
    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

    Full Information

    First Posted
    October 8, 2023
    Last Updated
    October 8, 2023
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06082115
    Brief Title
    Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
    Official Title
    Functional Outcome of Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    January 20, 2024 (Anticipated)
    Study Completion Date
    January 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beni-Suef University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unilateral Cerebral Palsy
    Keywords
    Mirror Therapy, Task Oriented Training, Hand Function, Unilateral Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Selected Physical Therapy Program, Mirror Therapy, Task Oriented Training
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Selected Physical and Occupational Therapy Program
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Mirror Therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Task Oriented Training
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Selected Physical and Occupational Therapy Program
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Mirror Therapy
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Task-Oriented Training
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Grip Strength
    Description
    Hand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.
    Time Frame
    Up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Range of Motion
    Description
    Electronic(digital) goniometer will be used for measuring wrist extension ROM. It is a valid and reliable tool used to assess wrist extension ROM
    Time Frame
    Up to 12 weeks
    Title
    Upper Extremity Skills
    Description
    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.
    Time Frame
    Up to 12 weeks
    Title
    Hand Dexetrity
    Description
    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
    Time Frame
    Up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Wagdy
    Phone
    01008079576
    Email
    Eman.wagdy@pt.bsu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy

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