The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS).
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessments for the main outcome will be performed by a blinded expert.
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The quality of General Movement by General Movements Optimality Score (GMOS-R) and Motor Optimality Score (MOS).
时间窗: Each participant will be assessed from birth to the 54 weeks PMA.
We will videotape General Movements at 34, 38-40, 44 and 54 weeks PMA. The baseline measure( 34w) will be performed by the main researcher and an independent and experienced certified rater. This rater will be blind regarding infant group. The assessments at 38-40, 44 and 54 weeks will be performed by the independent, blind and certified rater in order to guarantee the study validity. The GMOS-R global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 38. The MOS global assessment can be classified as Fidgety (F), Abnormal Fidgety (AF) or Absent Fidgety (F-). On the detailed score the maximum value is 28. Higher scores in both scales are correlated with better global outcome.
次要结局
- Motor development by Hammersmith Infant Neurological Scale (HINE).(6 months CA)
- Global development by Bayley III(12 months CA)
研究者
Susana Trallero Rodríguez
PhD candidate, MsC, Physiotherapist Susana Trallero Rodríguez
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta