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Effects of Action Observation Therapy and Mirror Therapy in Children With Unilateral Cerebral Palsy

Primary Purpose

Cerebral Palsy, Functioning, Upper Extremity Problem

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Action Observation Therapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being between the ages of 5 and 15 Being diagnosed with unilateral cerebral palsy Be in one of the levels 1,2 and 3 according to the MACS dexterity classification Upper extremity Modified Ashworth Scale score less than or equal to 2 attending primary school Exclusion Criteria: Having a visual impairment recorded in the health report To have any neurological, orthopedic, and psychiatric diagnosis in addition to the diagnosis of cerebral palsy Difficulty understanding and applying verbal and visual commands To have undergone any surgical intervention or botox in the last 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Cerebral Palsy

    Arm Description

    Outcomes

    Primary Outcome Measures

    The Canadian Occupational Performance Measure
    Assessment
    Goal Attainment Scaling
    Assessment
    Shriners Hospital Upper Extremity Evaluation
    Assessment
    Melbourne Assessment of Unilateral Upper Limb Function
    Assessment
    ABILHAND-Kids Questionnaire
    Assessment
    Visual Analogue Scale
    Assessment

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    July 10, 2023
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05951829
    Brief Title
    Effects of Action Observation Therapy and Mirror Therapy in Children With Unilateral Cerebral Palsy
    Official Title
    Effects of Action Observation Therapy and Mirror Therapy on Upper Extremity Functions in Children With Unilateral Cerebral Palsy: A Randomized Controlled Study With 1 Month Follow-Up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 10, 2023 (Anticipated)
    Primary Completion Date
    January 10, 2025 (Anticipated)
    Study Completion Date
    January 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe 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 aim of this study was to examine the effects of action observation therapy and mirror therapy on upper extremity functions in children with unilateral cerebral palsy. In the study, the 1st group is the Action Observation Therapy group and will receive 18 sessions of practice. The second group is the mirror therapy group and will receive a total of 18 practice sessions. To evaluate the outcome measures of children's upper extremity functions; Canadian Occupational Performance Mesure (COPM), Goal Achievement Scale (GAS), Shriners Hospital Upper Extremity Function Scale (SHUEE), Melbourne Unilateral Upper Extremity Function Evaluation Test and ABILHAND Questionnaire will be used. The satisfaction of the families with the therapy process will be evaluated with the Visual Analog Scale (VAS).
    Detailed Description
    The aim of this study was to examine the effects of action observation therapy and mirror therapy on upper extremity functions in children with unilateral cerebral palsy. In the study, the 1st group is the Action Observation Therapy group and will receive 18 sessions of practice. The second group is the mirror therapy group and will receive a total of 18 practice sessions. To evaluate the outcome measures of children's upper extremity functions; Canadian Occupational Performance Mesure (COPM), Goal Achievement Scale (GAS), Shriners Hospital Upper Extremity Function Scale (SHUEE), Melbourne Unilateral Upper Extremity Function Evaluation Test and ABILHAND Questionnaire will be used. The satisfaction of the families with the therapy process will be evaluated with the Visual Analog Scale (VAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Functioning, Upper Extremity Problem

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cerebral Palsy
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Action Observation Therapy
    Other Intervention Name(s)
    Mirror Therapy
    Intervention Description
    Action Observation Therapy Mirror Therapy
    Primary Outcome Measure Information:
    Title
    The Canadian Occupational Performance Measure
    Description
    Assessment
    Time Frame
    6 weeks
    Title
    Goal Attainment Scaling
    Description
    Assessment
    Time Frame
    6 weeks
    Title
    Shriners Hospital Upper Extremity Evaluation
    Description
    Assessment
    Time Frame
    6 weeks
    Title
    Melbourne Assessment of Unilateral Upper Limb Function
    Description
    Assessment
    Time Frame
    6 weeks
    Title
    ABILHAND-Kids Questionnaire
    Description
    Assessment
    Time Frame
    6 weeks
    Title
    Visual Analogue Scale
    Description
    Assessment
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being between the ages of 5 and 15 Being diagnosed with unilateral cerebral palsy Be in one of the levels 1,2 and 3 according to the MACS dexterity classification Upper extremity Modified Ashworth Scale score less than or equal to 2 attending primary school Exclusion Criteria: Having a visual impairment recorded in the health report To have any neurological, orthopedic, and psychiatric diagnosis in addition to the diagnosis of cerebral palsy Difficulty understanding and applying verbal and visual commands To have undergone any surgical intervention or botox in the last 3 months

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Action Observation Therapy and Mirror Therapy in Children With Unilateral Cerebral Palsy

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