Implementation of Therapy Together
Study Details
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:
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Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Therapy Together Participants will complete the 8-week Therapy Together program. |
Behavioral: Therapy Together
8-week caregiver-led pediatric constraint-induced movement therapy program
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| Active Comparator: Usual Care Participants will complete 8 weeks of usual care in early intervention. |
Behavioral: Usual Care
8 weeks of usual care received in an early intervention therapy program
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Outcome Measures
Primary Outcome Measures
- Mini-Assisting Hand Assessment [baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
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 [baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
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 [baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
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 [baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
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) [baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
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 [baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
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
Other Outcome Measures
- Pre-training and Post-training Therapist Survey [Baseline, pre-intervention and within 1 month of post-intervention]
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)
- Interviews with therapists and caregivers [Within 1 month of post intervention]
Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data
- Weekly Caregiver Log [weekly for 8 weeks]
The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4
- Weekly Therapist Log [weekly for 8 weeks]
Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses
Eligibility Criteria
Criteria
Inclusion Criteria:
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at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
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children ages 3 months to 2 years 11 months
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present with asymmetric hand use
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present with a unilateral upper limb impairment
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able to visually attend to objects
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demonstrate an interest in objects
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attempt to reach for or grasp objects with the impaired upper extremity
Exclusion Criteria:
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uncontrolled epilepsy
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significant visual impairment
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severe behavioral problems
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inability to complete the assessment protocol.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Texas Scottish Rite Hospital for Children
- American Occupational Therapy Foundation
Investigators
- Principal Investigator: Angela Shierk, PhD, Scottish Rite for Children
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU-2023-0553