The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.

Официальное название

The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.

Обзор

This study aims to assess the effect of a parent-administered intervention program based on MIT-PB in preterm with abnormal general movements during the preterm period. We will describe the short and long-term differences between infants exposed to MIT-PB and infants who follow current standard care.

Подробное описание

The quasi-experimental design has been planned to assess the effect of a physiotherapy program carried out in neonatal intensive care and at home during the first months of life. Preterm babies born before 32 weeks gestational age (GA) and/or with less than 1500g showing an abnormal General Movement Assessment (GMA) at 34-36 weeks will be included.

Standardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (PMA), 54 weeks PMA, 6 months, and 12 months.

A qualitative study has been designed to assess the physiotherapy performance and parents' experience.

Three different Hospitals with similar care protocols and sizes will recruit the sample (n=36). The Intervention groups (n=18) will be located at Hospital Josep Trueta of Girona and Hospital Sant Joan de Déu and the control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).

Вмешательства

• Другое MIT-PB, movement imitation therapy for preterm.
  The instant an infant showed CS or PR movements, the therapists (or a therapist and a parent) intervened by gently guiding the infants' limbs so as to maneuver and smoothen their movements, thereby imitating normal GM sequences as closely as possible, adding variability to the movement

Первичные конечные точки

• The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS). [Срок оценки: Each participant will be assessed from birth to the 54 weeks PMA.]

Вторичные конечные точки (2)

• Motor development by Hammersmith Infant Neurological Scale (HINE). [Срок оценки: 6 months CA]
• Global development by Bayley III [Срок оценки: 12 months CA]

Критерии участия

Критерии включения

• Preterm infants born before 32w GA and less than 1500g weight.
• Infants who show Abnormal General Movements (CS-PR pattern) at 34-36w postmenstrual age (PMA).
• Families able to understand/speak Catalan, Spanish or English.
• Families willing to participate who have the informed consent

Критерии исключения

• Infants with congenital abnormalities and/or genetic disorders
• Infants with invasive ventilation or Continuous Positive Airway Pressure (CPAP) at 36 weeks PMA.
• Infants with Normal General Movements at 34-36 w PMA.
• Families not willing to participate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 3 центра

• Hospital Sant Joan de Déu — Barcelona
• Hospital Parc Taulí de Sabadell — Sabadell
• Hospital Universitari Josep Trueta de Girona — Girona

Идентификаторы

NCT: NCT05319158 · 2021.002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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