xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040619</url>
    </required_header>
    <id_info>
      <org_study_id>STU-2023-0553</org_study_id>
      <nct_id>NCT06040619</nct_id>
    </id_info>
    <brief_title>Implementation of Therapy Together</brief_title>
    <official_title>Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Texas Scottish Rite Hospital for Children</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Occupational Therapy Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Texas Scottish Rite Hospital for Children</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot clinical trial is to learn about the implementation of Therapy&#xD;
        Together, a pediatric constraint-induced movement therapy program in young children with&#xD;
        unilateral cerebral palsy. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Is the Therapy Together program effective in improving hand function and occupational&#xD;
             performance compared to usual care?&#xD;
  &#xD;
          -  Is it feasible to implement the Therapy Together program within the standard care, early&#xD;
             intervention framework?&#xD;
  &#xD;
        Participants will participate in an 8-week pediatric constraint-induced movement therapy&#xD;
        program. Researchers will compare the group completing the Therapy Together Program to a&#xD;
        group that is receiving usual care to see if there is a difference in the change in hand&#xD;
        function, occupational performance, and development.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A pilot randomized waitlist control trial with early intervention therapists,&#xD;
        infants/toddlers (ages 3 mo - 2 yrs 11 mo) with unilateral cerebral palsy (or at risk for&#xD;
        developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed&#xD;
        by semi-structured interviews with caregivers and therapists will be utilized to examine the&#xD;
        implementation and effectiveness of Therapy Together within early intervention.&#xD;
  &#xD;
        Therapy Together Program:&#xD;
  &#xD;
        The Therapy Together program includes caregiver education and coaching on implementing&#xD;
        therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to&#xD;
        improve arm/hand function. The child and caregiver complete 8 sessions with their early&#xD;
        intervention therapist. The early intervention therapist is trained to educate the caregiver&#xD;
        on the Therapy Together program, demonstrate how to engage the child in therapeutic&#xD;
        activities, and observe the caregiver implement the program during each weekly session. The&#xD;
        first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final&#xD;
        intervention visit focuses on bimanual therapy (use of two hands).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mini-Assisting Hand Assessment</measure>
      <time_frame>baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention</time_frame>
      <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)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assisting Hand Assessment</measure>
      <time_frame>baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention</time_frame>
      <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)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hand Assessment for Infants</measure>
      <time_frame>baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention</time_frame>
      <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)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Canadian Occupational Performance Measure</measure>
      <time_frame>baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention</time_frame>
      <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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Developmental Assessment for Young Children, Second Edition (DAYC-2)</measure>
      <time_frame>baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention</time_frame>
      <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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measure of Hand and Arm Performance</measure>
      <time_frame>baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention</time_frame>
      <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</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pre-training and Post-training Therapist Survey</measure>
      <time_frame>Baseline, pre-intervention and within 1 month of post-intervention</time_frame>
      <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)</description>
    </other_outcome>
    <other_outcome>
      <measure>Interviews with therapists and caregivers</measure>
      <time_frame>Within 1 month of post intervention</time_frame>
      <description>Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data</description>
    </other_outcome>
    <other_outcome>
      <measure>Weekly Caregiver Log</measure>
      <time_frame>weekly for 8 weeks</time_frame>
      <description>The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4</description>
    </other_outcome>
    <other_outcome>
      <measure>Weekly Therapist Log</measure>
      <time_frame>weekly for 8 weeks</time_frame>
      <description>Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cerebral Palsy</condition>
    <condition>Hemiplegic Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Therapy Together</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will complete the 8-week Therapy Together program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will complete 8 weeks of usual care in early intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Therapy Together</intervention_name>
      <description>8-week caregiver-led pediatric constraint-induced movement therapy program</description>
      <arm_group_label>Therapy Together</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>8 weeks of usual care received in an early intervention therapy program</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  at risk for developing cerebral palsy or have been diagnosed with cerebral palsy&#xD;
  &#xD;
            -  children ages 3 months to 2 years 11 months&#xD;
  &#xD;
            -  present with asymmetric hand use&#xD;
  &#xD;
            -  present with a unilateral upper limb impairment&#xD;
  &#xD;
            -  able to visually attend to objects&#xD;
  &#xD;
            -  demonstrate an interest in objects&#xD;
  &#xD;
            -  attempt to reach for or grasp objects with the impaired upper extremity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  uncontrolled epilepsy&#xD;
  &#xD;
            -  significant visual impairment&#xD;
  &#xD;
            -  severe behavioral problems&#xD;
  &#xD;
            -  inability to complete the assessment protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>35 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Angela Shierk, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Scottish Rite for Children</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Angela Shierk, PhD</last_name>
      <phone>(469) 412-7172</phone>
      <phone_ext>1045</phone_ext>
      <email>angela.shierk@tsrh.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Heather Roberts, PhD</last_name>
      <phone>(214) 794-8117</phone>
      <email>hroberts3@twu.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Texas Scottish Rite Hospital for Children</investigator_affiliation>
      <investigator_full_name>Angela Shierk</investigator_full_name>
      <investigator_title>Clinical Scientist</investigator_title>
    </responsible_party>
    <keyword>constraint induced movement therapy</keyword>
    <keyword>caregiver coaching</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebral Palsy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040619
  org study id: STU-2023-0553
  nct id: NCT06040619
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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).
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention 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.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Mini-Assisting Hand Assessment
  time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
  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)
  measure: Assisting Hand Assessment
  time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
  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)
  measure: Hand Assessment for Infants
  time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
  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)
  measure: Canadian Occupational Performance Measure
  time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
  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)
  measure: Developmental Assessment for Young Children, Second Edition (DAYC-2)
  time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
  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)
  measure: Measure of Hand and Arm Performance
  time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
  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
  measure: Pre-training and Post-training Therapist Survey
  time frame: Baseline, pre-intervention and within 1 month of post-intervention
  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)
  measure: Interviews with therapists and caregivers
  time frame: Within 1 month of post intervention
  description: Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data
  measure: Weekly Caregiver Log
  time frame: weekly for 8 weeks
  description: The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4
  measure: Weekly Therapist Log
  time frame: weekly for 8 weeks
  description: Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses
  arm group label: Therapy Together
  arm group type: Experimental
  description: Participants will complete the 8-week Therapy Together program.
  arm group label: Usual Care
  arm group type: Active Comparator
  description: Participants will complete 8 weeks of usual care in early intervention.
  intervention type: Behavioral
  intervention name: Therapy Together
  description: 8-week caregiver-led pediatric constraint-induced movement therapy program
  arm group label: Therapy Together
  intervention type: Behavioral
  intervention name: Usual Care
  description: 8 weeks of usual care received in an early intervention therapy program
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 35 Months
  healthy volunteers: No
  last name: Angela Shierk, PhD
  role: Principal Investigator
  affiliation: Scottish Rite for Children
  last name: Angela Shierk, PhD
  phone: (469) 412-7172
  phone ext: 1045
  email: angela.shierk@tsrh.org
  last name: Heather Roberts, PhD
  phone: (214) 794-8117
  email: hroberts3@twu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Texas Scottish Rite Hospital for Children
  investigator full name: Angela Shierk
  investigator title: Clinical Scientist
  mesh term: Cerebral Palsy
  sharing ipd: No