Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays

Официальное название

Effects of Telematic Support in Physical Therapy Early Intervention on Infants At Risk of Neurodevelopmental Delays and Disorders

Обзор

The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.

Подробное описание

The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.

Вмешательства

• Другое Face-to-face standard treatment
  Individualized early intervention treatment on physical therapy area as usual in the early intervention facilities once a month for two months. Instructions will be given to the parents for follow-up at home to stimulate the baby's motor development until next face-to-face session.
• Другое Telematic Support
  The physiotherapist in charge of the telematic sessions will review and guide in real time through WhatsApp platform, the performance and active participation of the parents in the therapeutic activities being asked to follow-up at home in the face-to-face appointment, correcting, as necessary.

Первичные конечные точки

• Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2. [Срок оценки: Baseline and Month 2.]
• Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2. [Срок оценки: Baseline and Month 2.]
• Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2. [Срок оценки: Baseline and Month 2.]

Вторичные конечные точки (4)

• Change from Baseline in parents' quality of life on the Care-related quality of life (CarerQol) at month 2. [Срок оценки: Baseline and Month 2.]
• Change from Baseline in levels of stress experienced by parents on the Parental Stress Scale (PSS) at month 2. [Срок оценки: Baseline and Month 2.]
• Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8). [Срок оценки: Month 2]
• Change from Baseline in parental self-efficacy and satisfaction of being a parent on the Parenting Sense of Competence (PSOC) at month 2. [Срок оценки: Baseline and Month 2.]

Критерии участия

Критерии включения

• Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
• At risk of neurodevelopmental delays or disorders.
• Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.

Критерии исключения

• Independent walking children.
• Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
• Infants with orthoses and/or prostheses.
• Children with health complications that enable the child's participation in the study.
• Not spanish-speaking parents.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Hospital Universitario San Cecilio de Granada — Granada

Идентификаторы

NCT: NCT06608576 · BBL-ATPO-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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