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| Name | Class |
|---|---|
| Texas Woman's University | OTHER |
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The purpose of this project is to conduct a pilot hybrid type two implementation and efficacy study on Therapy Together with Early Childhood Intervention using an explanatory mixed methods approach to evaluate the efficacy and implementation of Therapy Together. Therapy Together is a parent led intensive pediatric constraint induced movement therapy (P-CIMT) program for young children (3 months-2 years 11 months) with unilateral cerebral palsy (UCP). The research team developed the Therapy Together program due to the lack of clinical uptake in use of CIMT with children with UCP, even though there is consistent and robust evidence that demonstrates a positive treatment effect with the intervention. Therapy Together is based on the evidence and active ingredients of P-CIMT with a primary focus on utility and translation of research to clinical practice.
The long-term research goal is to implement Therapy Together, a caregiver-led pediatric constraint induced movement therapy program we developed for infants and toddlers with unilateral cerebral palsy, within regular health care models globally. The objective of this proposal is to conduct a pilot study to evaluate the efficacy and implementation of the Therapy Together program within the State of Texas Early Childhood Intervention program by conducting a mixed method, hybrid type two implementation and efficacy study guided by the RE-AIM Framework focusing on reach, effectiveness, adoption, and implementation. The central hypothesis is that Therapy Together can be successfully implemented within the early intervention model resulting in clinically significant improvements in hand function, occupational performance, and development. The rationale for this hypothesis is that Therapy Together is an adapted version of an evidence-based intervention specifically developed for implementation within standard of care practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Togther | Experimental | Therapy Together is a parent led intensive pediatric constraint induced movement therapy (P-CIMT) program for young children (3 months-2 years 11 months) with unilateral cerebral palsy (UCP). The research team developed the Therapy Together program due to the lack of clinical uptake in use of CIMT with children with UCP, even though there is consistent and robust evidence that demonstrates a positive treatment effect with the intervention. Therapy Together is based on the evidence and active ingredients of P-CIMT with a primary focus on clinical utility and translation of research to clinical practice |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy Together | Behavioral | CIMT consists of retraining the preferred hand by covering the hand with a soft mitt to promote the use of the assisting hand. With consistent practice, a toddler or infant builds the fine and gross motor skills of their assisting hand and bilateral coordination skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Assisting Hand Assessment (Mini-AHA) | A semi-structured assessment for unilateral CP measuring effectiveness in bimanual hand | pre-intervention and immediate post-intervention |
| Canadian Occupational Performance Measure (COPM) | A semi-structured interview that allows caregivers to evaluate and prioritize their child's current participation in the areas of self-care, leisure, and play | pre-intervention and immediate post-intervention |
| Developmental Assessment of Young Children, Second Edition (DAYC-2) | The DAYC-2 is a normative-based assessment to identify children from birth to 5 years of age to assess a child's ability in areas of cognition, communication, social-emotional development, physical development, and adaptive behavior | pre-intervention and immediate post-intervention |
| Measure of Hand and Arm Performance | The measure of hand and arm performance is an observation-based assessment of upper extremity movements developed by the researchers. | pre-intervention and immediate post-intervention |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Woman's Univeristy | Denton | Texas | 76201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17355470 | Background | Armstrong RW. Definition and classification of cerebral palsy. Dev Med Child Neurol. 2007 Mar;49(3):166. doi: 10.1111/j.1469-8749.2007.00166.x. No abstract available. | |
| 21489387 | Background | Cioni G, D'Acunto G, Guzzetta A. Perinatal brain damage in children: neuroplasticity, early intervention, and molecular mechanisms of recovery. Prog Brain Res. 2011;189:139-54. doi: 10.1016/B978-0-444-53884-0.00022-1. |
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| ID | Term |
|---|---|
| D000098483 | Constraint Induced Movement Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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pre- and post- assessment
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| Background | Creswell, J. W., & Creswell, J. D. (2018). Research design: Qualitative, quantitative, and mixed methods approaches. (5th ed). Sage Publications, 267-276. |
| 16780622 | Background | Eliasson AC, Krumlinde-Sundholm L, Rosblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. doi: 10.1017/S0012162206001162. |
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| Background | Palisano, R., Rosenbaum, P., Bartlett, D., & Livingston, M. (2007). Gross Motor Classification System expanded and revised. CanChild Centre for Childhood Disability Research. Retrieved on July 1, 2023 from https://canchild.ca/system/tenon/assets/attachments/000/000/058/original/GMFCS-ER_English.pdf |
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| 17943507 | Background | Saleh MN, Korner-Bitensky N, Snider L, Malouin F, Mazer B, Kennedy E, Roy MA. Actual vs. best practices for young children with cerebral palsy: a survey of paediatric occupational therapists and physical therapists in Quebec, Canada. Dev Neurorehabil. 2008 Jan-Mar;11(1):60-80. doi: 10.1080/17518420701544230. |
| Background | Shierk, A., Roberts, H., Dubberly, K., Clegg, N. J., Fagan, M., Baldwin, D., Reyes, F., VanPelt, J., & Delgado, M. R. (2023). Therapy together: A caregiver led constraint induced movement therapy program for preschool aged children utilizing a virtual environment due to COVID 19. Journal of Occupational Therapy, Schools, and Early Intervention, 16(1), 39-50. https://doi.org/10.1080/19411243.2021.2003738 |
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