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Acceptability and Efficacy of GO MOVE

Primary Purpose

Cerebral Palsy, Hemiplegic Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Program
Sponsored by
Texas Scottish Rite Hospital for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring home program

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria for participants to enroll in the study include a diagnosis of unilateral CP or a non-progressive brain lesion, injury, or trauma of the developing brain that presents with a unilateral upper limb motor impairment. GMFCS levels 1 or 2. MACS levels 1-3. Age 3-17 years old, ability to follow directions, ability to complete the assessment protocol, and the ability to access the GO MOVE webpage on a personal device. All ethnic/racial groups will be eligible to participate. The ability to participate in everyday activities without restriction from a physician throughout the duration of their participation in the study (does not have restrictions/contraindications following a medical procedure). Exclusion Criteria: The study will exclude any patients with uncontrolled epilepsy or significant visual impairment. The study will exclude any patient with severe behavioral problems or the inability to complete the assessment protocol or home program.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Go Move Home Program

    Arm Description

    Goal driven home program

    Outcomes

    Primary Outcome Measures

    Canadian Occupational Performance Measure (COPM)
    The Canadian Occupational Performance Measure is a criterion referenced, individualized, client-centered outcome measure designed for use by occupational therapists to detect change in a client's self-perception of occupational performance over time on a scale of 1-10 (1 being the lowest)

    Secondary Outcome Measures

    Goal Attainment Scale (GAS) Light
    The Goal Attainment Scale is an individualized, functional outcome measure involving goal selection and scaling. The scale ranges from -2 to +2 with -2 representing a decline in function, -1 no change, 0 expected outcome, +1 a little more, +2 a lot more.
    Assisting Hand Assessment (AHA) (optional)
    The Assisting Hand Assessment is a criterion referenced, valid and reliable 22-item measure that assesses the assisting or affected hand in carrying out bimanual activities for children with cerebral palsy or obstetric brachial plexus palsy measured by AHA units on a scale of 0-100 with 0 being the lowest level of function.

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Texas Scottish Rite Hospital for Children
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06048419
    Brief Title
    Acceptability and Efficacy of GO MOVE
    Official Title
    Acceptability and Efficacy of GO MOVE: A Mobile Health Technology for Youth 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 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Texas Scottish Rite Hospital for Children

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about the acceptability and efficacy of Go Move, a mobile website developed to assist youth with unilateral cerebral palsy and their caregivers with setting goals and selecting exercises and activities to meet the goals. The main question[s] it aims to answer are: Is Go Move accepted by youth with unilateral cerebral palsy and their caregivers? Does Go Move support goal attainment for youth with unilateral cerebral palsy? Participants will set up and participate in a goal-driven home program using the Go Move mobile website. Participants will spend 1 hour and 15 minutes per week for 6 weeks working on their home program and will complete pre-intervention and post-intervention assessments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Hemiplegic Cerebral Palsy
    Keywords
    home program

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Go Move Home Program
    Arm Type
    Experimental
    Arm Description
    Goal driven home program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Home Program
    Intervention Description
    Home program for 6 weeks (1 hr and 15 minutes per week)
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure (COPM)
    Description
    The Canadian Occupational Performance Measure is a criterion referenced, individualized, client-centered outcome measure designed for use by occupational therapists to detect change in a client's self-perception of occupational performance over time on a scale of 1-10 (1 being the lowest)
    Time Frame
    within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
    Secondary Outcome Measure Information:
    Title
    Goal Attainment Scale (GAS) Light
    Description
    The Goal Attainment Scale is an individualized, functional outcome measure involving goal selection and scaling. The scale ranges from -2 to +2 with -2 representing a decline in function, -1 no change, 0 expected outcome, +1 a little more, +2 a lot more.
    Time Frame
    within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
    Title
    Assisting Hand Assessment (AHA) (optional)
    Description
    The Assisting Hand Assessment is a criterion referenced, valid and reliable 22-item measure that assesses the assisting or affected hand in carrying out bimanual activities for children with cerebral palsy or obstetric brachial plexus palsy measured by AHA units on a scale of 0-100 with 0 being the lowest level of function.
    Time Frame
    within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
    Other Pre-specified Outcome Measures:
    Title
    Demographic information
    Description
    Demographic in formation will be collected including: age in years and months, gender, etiology of cerebral palsy, qualitative description of previous exposure to therapy
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    Gross Motor Function Classification System (GMFCS)
    Description
    The Gross Motor Function Classification Systems is a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy with 1 being the lowest functioning and 5 being the highest
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    Manual Ability Classification Scale (MACS)
    Description
    The Manual Ability Classification Scale describes how children with cerebral palsy use their hands during activities of daily living with 1 being the least functional and 5 being the most functional
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    Mobile App Rating Scale (MARS)
    Description
    The Moblie App Rating Scale is an objective, multidimensional tool to assess the quality of mobile health apps using likert scaling with 1 being the lowest rating and 5 being the highest
    Time Frame
    within 2 weeks of end of intervention (post-intervention)
    Title
    Feasibility and satisfaction with using the Go Move website
    Description
    A likert scale from 1-5 on the satisfaction and ease of using the Go Move website and qualitative data collection with 1 being the lowest rating and 5 being the highest
    Time Frame
    within 2 weeks of end of intervention (post-intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria for participants to enroll in the study include a diagnosis of unilateral CP or a non-progressive brain lesion, injury, or trauma of the developing brain that presents with a unilateral upper limb motor impairment. GMFCS levels 1 or 2. MACS levels 1-3. Age 3-17 years old, ability to follow directions, ability to complete the assessment protocol, and the ability to access the GO MOVE webpage on a personal device. All ethnic/racial groups will be eligible to participate. The ability to participate in everyday activities without restriction from a physician throughout the duration of their participation in the study (does not have restrictions/contraindications following a medical procedure). Exclusion Criteria: The study will exclude any patients with uncontrolled epilepsy or significant visual impairment. The study will exclude any patient with severe behavioral problems or the inability to complete the assessment protocol or home program.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angela Shierk, PhD
    Phone
    4694127172
    Ext
    1045
    Email
    angela.shierk@tsrh.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heather Roberts, PhD
    Phone
    214-794-8117
    Email
    hroberts3@twu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angela Shierk, PhD
    Organizational Affiliation
    Scottish Rite for Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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