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| Name | Class |
|---|---|
| American Occupational Therapy Foundation | OTHER |
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The goal of this 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:
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 randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 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 therapist. The 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Together | Experimental | Participants will complete the 8-week Therapy Together program. |
|
| Usual Care | Active Comparator | Participants will complete 8 weeks of usual care in early intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy Together | Behavioral | 8-week caregiver-led pediatric constraint-induced movement therapy program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| 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) | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| 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) | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-training and Post-training Therapist Survey | 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) | Baseline, pre-intervention and within 1 month of post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Shierk, PhD | Contact | (469) 412-7172 | 1045 | angela.shierk@tsrh.org |
| Heather Roberts, PhD | Contact | (214) 794-8117 | hroberts3@twu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Shierk, PhD | Scottish Rite for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottish Rite for Children | Recruiting | Frisco | Texas | 75034 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Usual Care | Behavioral | 8 weeks of usual care received in an early intervention therapy program |
|
| 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) |
| baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| 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 | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| Interviews with therapists and caregivers | Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data | Within 1 month of post intervention |
| Weekly Caregiver Log | The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4 | weekly for 8 weeks |
| Weekly Therapist Log | Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses | weekly for 8 weeks |