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Implementation of Therapy Together

Primary Purpose

Cerebral Palsy, Hemiplegic Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapy Together
Usual Care
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 constraint induced movement therapy, caregiver coaching

Eligibility Criteria

3 Months - 35 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: at risk for developing cerebral palsy or have been diagnosed with cerebral palsy children ages 3 months to 2 years 11 months present with asymmetric hand use present with a unilateral upper limb impairment able to visually attend to objects demonstrate an interest in objects attempt to reach for or grasp objects with the impaired upper extremity Exclusion Criteria: uncontrolled epilepsy significant visual impairment severe behavioral problems inability to complete the assessment protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Therapy Together

    Usual Care

    Arm Description

    Participants will complete the 8-week Therapy Together program.

    Participants will complete 8 weeks of usual care in early intervention.

    Outcomes

    Primary Outcome Measures

    Mini-Assisting Hand Assessment
    The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)
    Assisting Hand Assessment
    The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)
    Hand Assessment for Infants
    The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)

    Secondary Outcome Measures

    Canadian Occupational Performance Measure
    The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10)
    Developmental Assessment for Young Children, Second Edition (DAYC-2)
    The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores)
    Measure of Hand and Arm Performance
    The Measure of Hand and Arm Performance is a criterion-referenced, observational assessment of hand and arm use based on observation, measured on a scale of 1-10

    Full Information

    First Posted
    August 28, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Texas Scottish Rite Hospital for Children
    Collaborators
    American Occupational Therapy Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06040619
    Brief Title
    Implementation of Therapy Together
    Official Title
    Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
    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
    May 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Texas Scottish Rite Hospital for Children
    Collaborators
    American Occupational Therapy Foundation

    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 pilot clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question[s] it aims to answer are: Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care? Is it feasible to implement the Therapy Together program within the standard care, early intervention framework? Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.
    Detailed Description
    A pilot randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 2 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention. Therapy Together Program: The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. The child and caregiver complete 8 sessions with their early intervention therapist. The early intervention therapist is trained to educate the caregiver on the Therapy Together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).

    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
    constraint induced movement therapy, caregiver coaching

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Pilot randomized control trial comparing treatment group to usual care. The usual care group will have the option to cross over to the treatment group after 8 weeks.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapy Together
    Arm Type
    Experimental
    Arm Description
    Participants will complete the 8-week Therapy Together program.
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm Description
    Participants will complete 8 weeks of usual care in early intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Therapy Together
    Intervention Description
    8-week caregiver-led pediatric constraint-induced movement therapy program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    8 weeks of usual care received in an early intervention therapy program
    Primary Outcome Measure Information:
    Title
    Mini-Assisting Hand Assessment
    Description
    The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)
    Time Frame
    baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Title
    Assisting Hand Assessment
    Description
    The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)
    Time Frame
    baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Title
    Hand Assessment for Infants
    Description
    The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)
    Time Frame
    baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Secondary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure
    Description
    The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10)
    Time Frame
    baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Title
    Developmental Assessment for Young Children, Second Edition (DAYC-2)
    Description
    The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores)
    Time Frame
    baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Title
    Measure of Hand and Arm Performance
    Description
    The Measure of Hand and Arm Performance is a criterion-referenced, observational assessment of hand and arm use based on observation, measured on a scale of 1-10
    Time Frame
    baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Other Pre-specified Outcome Measures:
    Title
    Pre-training and Post-training Therapist Survey
    Description
    The pre-training and post-training survey includes questions on knowledge, appropriateness, and acceptability of pediatric constraint-induced movement therapy (includes likert scale questions, demographic questions, and open ended qualitative responses)
    Time Frame
    Baseline, pre-intervention and within 1 month of post-intervention
    Title
    Interviews with therapists and caregivers
    Description
    Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data
    Time Frame
    Within 1 month of post intervention
    Title
    Weekly Caregiver Log
    Description
    The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4
    Time Frame
    weekly for 8 weeks
    Title
    Weekly Therapist Log
    Description
    Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses
    Time Frame
    weekly for 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    35 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: at risk for developing cerebral palsy or have been diagnosed with cerebral palsy children ages 3 months to 2 years 11 months present with asymmetric hand use present with a unilateral upper limb impairment able to visually attend to objects demonstrate an interest in objects attempt to reach for or grasp objects with the impaired upper extremity Exclusion Criteria: uncontrolled epilepsy significant visual impairment severe behavioral problems inability to complete the assessment protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angela Shierk, PhD
    Phone
    (469) 412-7172
    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

    Learn more about this trial

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