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the Effectiveness of Task-oriented Training With Pretend Play in CP Children

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
task-oriented training with pretend play
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

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

Inclusion Criteria: Hemiplegic CP children of both genders. Their age range will be from 6 up to 8 years. They will be have spasticity will range from 1+ and 2, spasticity will be diagnosed based on the modified Ashworth scale. They will be have gross motor function at levels II and III, gross motor function will be diagnosed based on Gross Motor Function Classification System Expanded and Revised. They will be able to understand and follow direction. Exclusion Criteria: Any visual or auditory impairments. Epilepsy. Any cognitive disorder. Any fracture or orthopedic surgery in the last 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Group A (control group)

    Group B (study group)

    Arm Description

    The children in this group will receive physical therapy exercises to improve gross motor function and functional performance for 30 minutes per session ,3 times per week for three successive months as the following: Forward and sideways walking between parallel bars, as well as walking training with a stepper. Obstacles such as rolls and wedges are placed across the walking track during gait training in an open manner

    Task-oriented training with pretend play treatment: Individual interviews will be conducted with subjects and their parents to find their favorite story and to set up a pretend play situation for each subject. The child will have his specific script, will be constructed from his favorite story. The physical therapist will use modeling, prompts, and encouragement to initiate pretend play. Actions and verbalization on the scripts will be constructed to describe the performance of activities based on task-oriented training which include: Forward, sideways and backward walking. Walking through obstacle course. Walking up and down stairs. Walking up and down ramps. Running. Jumping. Each task will be given for 4 minutes and one minute rest. The child will be encouraged to complete the task and will be verbally cued during training. Tasks will be progressed according to each child's performance. These progressions included increasing the number of repetitions, and speed.

    Outcomes

    Primary Outcome Measures

    change from baseline in cognitive function on Wechsler intelligence scale for children (WISC-IV) at week13
    WISC-IV is a valid instrument assessing cognitive function. It consists of 10 core subtests and 5 supplementary subtests. it provides four index scores, The Full-Scale Intelligent Quotient can be obtained from the sum of the 10 core sub test scores. change= (Week 13 score - Baseline score).
    change from baseline in functional capacity on six minutes walk test at week 13
    six minutes walk test is a validated instrument assessing functional capacity. For the 6 - minute walking test during overground walking, the children will be encouraged to walk on 30 meters hard and even surface corridor for 6- minutes . Change = (week 13 score -Baseline score).
    change from baseline in gross motor function on Gross Motor Function Measure (GMFM) at week 13
    Gross Motor Function Measure is a valid, and reliable standardized assessment tool that measures change in gross motor function. It consists of 88 items grouped into five functional dimensions. Score of each item has four points ranging from 0 to 3; where 0 indicates that the child does not initiate the task; 3 indicates that the child completes the task (100%). change = (week 13 score -Baseline score).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2023
    Last Updated
    July 31, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05972499
    Brief Title
    the Effectiveness of Task-oriented Training With Pretend Play in CP Children
    Official Title
    Therapeutic Outcomes of Task-oriented Training With Pretend Play in Children With Cerebral Palsy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    the effectiveness of task - oriented training with pretend play on gross motor function, functional capacity and cognitive function in children with hemiplegic cerebral palsy.
    Detailed Description
    PURPOSE: This study aims to investigate the effectiveness of task-oriented training with pretend play on: gross motor function, functional capacity and cognitive function in children with hemiplegic CP. BACKGROUND: Children with HCP experience difficulty with the motor function of the affected lower extremity. The majority of children with hemiplegia are able to walk without restrictions but more advanced gross motor skills are often affected. Task-Oriented Training is a contemporary neurological rehabilitation technique that has the prospects of improving the quality of life of children with CP. It is a function-based, goal directed intervention that requires active involvement of the patient in a therapy that is task and context-specific, which focused on the accomplishment of functional activities and participation. Pretend play is defined as play in which the child acts with intent that is representational. pretend play helps children learn how to express themselves, explore social interactions, and understand things and people within a real-world context. HYPOTHESES: There is effect of task-oriented training with pretend play on gross motor function, functional capacity and cognitive function in children with hemiplegic CP. . ………………… RESEARCH QUESTION: Does task-oriented training with pretend play has an effect on gross motor function, functional capacity and cognitive function in children with hemiplegic CP?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (control group)
    Arm Type
    Placebo Comparator
    Arm Description
    The children in this group will receive physical therapy exercises to improve gross motor function and functional performance for 30 minutes per session ,3 times per week for three successive months as the following: Forward and sideways walking between parallel bars, as well as walking training with a stepper. Obstacles such as rolls and wedges are placed across the walking track during gait training in an open manner
    Arm Title
    Group B (study group)
    Arm Type
    Active Comparator
    Arm Description
    Task-oriented training with pretend play treatment: Individual interviews will be conducted with subjects and their parents to find their favorite story and to set up a pretend play situation for each subject. The child will have his specific script, will be constructed from his favorite story. The physical therapist will use modeling, prompts, and encouragement to initiate pretend play. Actions and verbalization on the scripts will be constructed to describe the performance of activities based on task-oriented training which include: Forward, sideways and backward walking. Walking through obstacle course. Walking up and down stairs. Walking up and down ramps. Running. Jumping. Each task will be given for 4 minutes and one minute rest. The child will be encouraged to complete the task and will be verbally cued during training. Tasks will be progressed according to each child's performance. These progressions included increasing the number of repetitions, and speed.
    Intervention Type
    Other
    Intervention Name(s)
    task-oriented training with pretend play
    Intervention Description
    Pretend play: Children engage in pretend play by acting out themes, taking on roles, assigning attributes to inanimate objects, and using objects as if they were something else Props will be added to hold the child interest. Role play costumes, or occupation props (police officer's suit), stimulate pretending elements. Task-oriented training: It is involving the active, repetitive practice of functional activities to learn or relearn a motor skill. Training implies that the behavioral experiences are not just repetition of the same sensorimotor skill but involves progressive challenges to a participant's capabilities and involves tasks that are meaningful to the participant. It is based on the following principles: functional goal-directed training focus on practicing specific activities of importance to the child during daily activities; planning activity-focused interventions by adapting knowledge of motor learning ; and allowing for the interest and participation of the children.
    Primary Outcome Measure Information:
    Title
    change from baseline in cognitive function on Wechsler intelligence scale for children (WISC-IV) at week13
    Description
    WISC-IV is a valid instrument assessing cognitive function. It consists of 10 core subtests and 5 supplementary subtests. it provides four index scores, The Full-Scale Intelligent Quotient can be obtained from the sum of the 10 core sub test scores. change= (Week 13 score - Baseline score).
    Time Frame
    Baseline and week 13
    Title
    change from baseline in functional capacity on six minutes walk test at week 13
    Description
    six minutes walk test is a validated instrument assessing functional capacity. For the 6 - minute walking test during overground walking, the children will be encouraged to walk on 30 meters hard and even surface corridor for 6- minutes . Change = (week 13 score -Baseline score).
    Time Frame
    Baseline and week 13
    Title
    change from baseline in gross motor function on Gross Motor Function Measure (GMFM) at week 13
    Description
    Gross Motor Function Measure is a valid, and reliable standardized assessment tool that measures change in gross motor function. It consists of 88 items grouped into five functional dimensions. Score of each item has four points ranging from 0 to 3; where 0 indicates that the child does not initiate the task; 3 indicates that the child completes the task (100%). change = (week 13 score -Baseline score).
    Time Frame
    Baseline and week 13

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hemiplegic CP children of both genders. Their age range will be from 6 up to 8 years. They will be have spasticity will range from 1+ and 2, spasticity will be diagnosed based on the modified Ashworth scale. They will be have gross motor function at levels II and III, gross motor function will be diagnosed based on Gross Motor Function Classification System Expanded and Revised. They will be able to understand and follow direction. Exclusion Criteria: Any visual or auditory impairments. Epilepsy. Any cognitive disorder. Any fracture or orthopedic surgery in the last 6 months.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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