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e-EARLY TOGETHER Intervention for Infants at High Risk of Cerebral Palsy: Randomized Controlled Trial Protocol
Agnes F S Cunha1, Hércules R Leite, Adriana N Santos
1Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil (Ms Cunha); Department of Physical Therapy, Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil (Dr Leite); Department of Health Sciences, Graduate Program in Rehabilitation Sciences, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, Brazil (Dr Santos); Department of Physical Therapy, Graduate Program in Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil (Dr Campos); Postdoctoral Research Fellow, Cerebral Palsy Alliance Research Institute, The University of Sydney, Camperdown, New South Wales, Australia (Dr Hines); Department of Physical Therapy, Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil (Dr Camargos).
Purpose:
The purpose of this study is to evaluate the effectiveness of an early intervention program, e-EARLY TOGETHER, that combines goal-oriented training, parental coaching, environmental enrichment in a telehealth approach in a low- and middle-income country.
Methods:
Protocol for a randomized controlled clinical trial to evaluate the effectiveness of e-EARLY TOGETHER intervention compared to standard guidelines on outcomes related to development and performance in infants at high risk of cerebral palsy.
Discussion:
This protocol will inform and enrich clinical practice related to early intervention in low- and middle-income countries. It is expected that the data obtained will contribute to the implementation of effective early intervention programs with positive and lasting results for the child, their family, and the community.
Trial Registration:
Brazilian Registry of Clinical Trials: RBR-7WWJRQ3, registered May 10, 2023; WHO Trial Registration UTN Code U-1111-1286-4639.
