The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Compare the motor performance using Test for Infant Motor Performance(TIMP)
研究概览
简要总结
The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is:
Will physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected age when compared to the preterm infants receiving standard care of parental education? In this study the motor performance of the preterm infants receiving physical therapy intervention and standard care will be compared.
详细描述
After receiving parental consent, preterm infants meeting the eligibility criteria will be enrolled for the study. 28 preterm infants will be enrolled and followed up from 40 weeks till 3 months of corrected age.
The preterm infants in the intervention group will receive modified supporting play, exploration and early development intervention(SPEEDI) and the standard group will receive standard care. The intervention for both groups will be provided by the physical therapists. The SPEEDI intervention should be carried out by the parent for at least 20mins/day for 5 days in a week. The parent will be asked to bring the infants for monthly follow up.
The motor performance of the preterm infants from this two groups will be assessed at 40 weeks, 1, 2 and 3 months of corrected age. The measurement tool that will be used to assess the preterm infants are Test for Infant Motor Performance(TIMP) and Rapid Neurodevelopment Assessment(RNDA). The assessment will be performed by therapist who will be blinded to the group allocation.
The end point of the study is at 3 months of corrected age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Double blinded with the outcome assessor blinded to the group allocation and the parent of preterm infants will be blinded since they will be scheduled for appointment on the different day. The outcome assessor will not be disclosed with the infants information, such as age , any medical diagnosis and group identification.
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born between 28 -34 weeks of gestation
- •Medically stable and off ventilator at the time of discharge from the hospital
- •Parents who consent to come for follow up
排除标准
- •Cortical blindness or retinopathy of prematurity causing blindness
- •Musculoskeletal/congenital abnormalities
- •Brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus
- •Genetic syndrome
- •Family who do not consent
- •Parent with physical and psychological problems
- •Infants with medical devices such as NG tube and gastrostomy
- •Infants who have undergone major surgery
结局指标
主要结局
Compare the motor performance using Test for Infant Motor Performance(TIMP)
时间窗: 40 weeks, 1, 2, and 3 months of corrected age
TIMP is a validated tool to measure the motor performance from 34 weeks post menstrual age through 4 months corrected age. The 42 items on the test provides comprehensive assessment of head and trunk control and arms and legs movement. The total score of TIMP ranges from 0-142 with higher scores representing better motor outcome and lower score representing motor delay.
次要结局
- Compare the neurodevelopment using Rapid Neurodevelopment Assessment(RNDA)(40 weeks, 1, 2, and 3 months of corrected age)
研究者
Karma Lhaki
Deputy Chief Physiotherapist
JDWNRH