Implementation of Therapy Together With Early Childhood Intervention
NCT ID: NCT06853717
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2022-02-16
2023-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapy Togther
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
Therapy Together
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.
Interventions
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Therapy Together
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants were children three months to two years and eleven months old who presented with asymmetric hand use with risk of developing cerebral palsy (CP) or have already been diagnosed with CP that present with unilateral upper limb impairment. Inclusion criteria were children who visually attended to objects, showed interest in them, and tried to reach for or grasp objects with their impaired upper extremity were included in the study.
Exclusion Criteria:
* Exclusion criteria were children with uncontrolled epilepsy, significant visual impairment, severe behavior problems or unable to complete assessment protocol were not included in the study.
3 Months
3 Years
ALL
No
Sponsors
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Texas Woman's University
OTHER
Texas Scottish Rite Hospital for Children
OTHER
Responsible Party
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Locations
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Texas Woman's Univeristy
Denton, Texas, United States
Countries
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References
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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.
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.
Creswell, J. W., & Creswell, J. D. (2018). Research design: Qualitative, quantitative, and mixed methods approaches. (5th ed). Sage Publications, 267-276.
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.
Eliasson AC, Nordstrand L, Ek L, Lennartsson F, Sjostrand L, Tedroff K, Krumlinde-Sundholm L. The effectiveness of Baby-CIMT in infants younger than 12 months with clinical signs of unilateral-cerebral palsy; an explorative study with randomized design. Res Dev Disabil. 2018 Jan;72:191-201. doi: 10.1016/j.ridd.2017.11.006. Epub 2017 Nov 23.
Eliasson AC, Ullenhag A, Wahlstrom U, Krumlinde-Sundholm L. Mini-MACS: development of the Manual Ability Classification System for children younger than 4 years of age with signs of cerebral palsy. Dev Med Child Neurol. 2017 Jan;59(1):72-78. doi: 10.1111/dmcn.13162. Epub 2016 Jun 8.
Lidbeck C, Habel H, Martinsson C, Pettersson K, Lowing K. Motor Development in Children with Cerebral Palsy in Sweden-A Population-Based Longitudinal Register Study. Children (Basel). 2023 Nov 28;10(12):1864. doi: 10.3390/children10121864.
Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
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
Ramey SL, DeLuca SC, Stevenson RD, Conaway M, Darragh AR, Lo W; CHAMP. Constraint-Induced Movement Therapy for Cerebral Palsy: A Randomized Trial. Pediatrics. 2021 Nov;148(5):e2020033878. doi: 10.1542/peds.2020-033878. Epub 2021 Oct 14.
Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23.
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.
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
Squires A, Sadarangani T, Jones S. Strategies for overcoming language barriers in research. J Adv Nurs. 2020 Feb;76(2):706-714. doi: 10.1111/jan.14007. Epub 2019 Jun 17.
Svensson K, Sundelin H, Eliasson AC. Outcomes of a Parent-Delivered Baby-mCIMT Model for Infants at High Risk of Unilateral Cerebral Palsy Using Remote Coaching in Telerehabilitation. Children (Basel). 2024 Jan 15;11(1):101. doi: 10.3390/children11010101.
Texas Health and Human Services Commission. (n.d.). Early childhood intervention services (ECI). Retrieved on July 1, 2023 from https://www.hhs.texas.gov/services/disability/early-childhood-intervention-services-eci
U.S. Census Bureau. (2022). Limited English speaking households. American Community Survey, ACS 1-Year Estimates Subject Tables, Table S1602. https://data.census.gov/table/ACSST1Y2022.S1602?t=Language Spoken at Home&g=040XX00US48
World Health Organization. (2007). International classification of functioning, disability and health, children & youth version (ICF-CY). World Health Organization. https://www.who.int/standards/classifications/international-classification-of-functioning-disability-and-health
Other Identifiers
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IRB-FY2022-258
Identifier Type: -
Identifier Source: org_study_id
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