Impact of an Orthotic Garment on Gross Motor Skill Acquisition for Infants With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Change in Gross Motor Function Measure - 88 (GMFM-88
研究概览
简要总结
Infants with Down syndrome (DS) develop slower than their typically developing peers. Physical therapist (PT) supervised home programs have the potential to optimize gross motor development in a financially feasible way. An inexpensive orthotic garment (Hip Helpers®) is commonly employed by PTs as a home program supplement, but its effectiveness has not yet been investigated. The garment is worn as pliable shorts over a child's lower extremities to keep upper legs together, promoting a narrow base of support. This encourages activation of upright postural muscles to improve gross motor skill development. The purpose of this randomized controlled study is to investigate the impact of a home program using the Hip Helpers® orthotic garment on gross motor skill acquisition in infants with DS. We hypothesize that the addition of a structured home program using Hip Helpers®, supervised by a PT and implemented by parents, will increase the rate at which infants with DS acquire gross motor skills. Thirty-four participants, consisting of children who are at least three-months-old and are not yet able maintain sitting independently, will be randomly assigned to a control (n=17) or intervention group (n=17). PTs at pediatric therapy agencies will initiate the home program and administer the Gross Motor Function Measure-88 (GMFM-88) at regular intervals to monitor gross motor skill acquisition until the child is able to take three independent steps. Groups will be compared on the length of time elapsed between the acquisition of identified gross motor skills using independent t-tests. GMFM-88 scores will be compared between the two groups at different ages to identify trends using independent t-tests. The contribution of this project will be significant by informing physical therapists about the effectiveness of an inexpensive orthotic garment used in a supervised home program on gross motor outcomes in infants with DS.
详细描述
PTs at local Early Intervention and pediatric home health agencies will be recruited to administer the home program and GMFM-88 (Appendix D) tests on their patients that consent to participate in the study.
Recruitment of PTs will occur through an email sent to the local agencies. (Appendix E) The PTs (additional personnel) will watch a GMFM-88 training video. They will be given a GMFM-88 manual, and blank protocols.
Recruitment of participants will occur by the PTs, who are treating patients in a home health environment. The PTs will offer the opportunity to participate in the study to any of their patients/clients that meet the inclusion criteria by handing them a flyer about the study (Appendix A. If the parent of the potential participant is interested, the PT will ask the parent to call or email the closest investigator for more information (Austin, TX, San Marcos, CA, or St. Augustine, FL). The study investigator will discuss the study with the parent and, if parents decide to participate, email the informed consent to the parent. Parents who choose to participate will sign the informed consent form, which a study investigator will read and explain to the parents over the phone if requested. The parent will sign the informed consent in front of an investigator or the additional personnel PT.
PTs will take a course on the responsible conduct of research through CITI. They will also be trained by one of the investigators on the protocol of how to properly conduct the study. The investigator will instruct the PTs that they may not coerce or discuss the study with potential participants, but can only hand the recruitment flyer to the parent of the participant. The PT will not ask the parent about their participation further after handing them the flyer. If the parent has questions, the PT will instruct the parent to contact the investigator for more information. The PT will also be instructed that data collection will not begin until the parent has signed the informed consent and the investigator has given the participant a number and randomly assigned the participant to a group.
Parental consent will be obtained prior to any data collection. (Appendix C) Parents will complete a short demographic survey about their children (Appendix F).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of DS
- •between the ages of three to nine months
- •not able to maintain upright sitting independently
排除标准
- •a diagnosis unrelated to DS that limits gross motor movement
- •medical restrictions that contraindicate movement
- •a history of hip displacement or dislocation
结局指标
主要结局
Change in Gross Motor Function Measure - 88 (GMFM-88
时间窗: Assessed every 4 weeks from randomization until child takes three independent steps, up to 36 months
The GMFM-88 is a measure of gross motor function for children with Down syndrome (DS) under six years old. The examiner scores a child's capabilities across five dimensions of functional movement: A) Lying and Rolling, B) Sitting, C) Crawling and Kneeling, D) Standing, and E) Walking, Running, and Jumping. Each dimension consists of several items on an ordinal scale. The child receives a score of 0 (does not initiate), 1 (initiates), 2 (partially completes), or 3 (completes). This outcome measure can be administered by direct observation or by parent report. For children with DS, the GMFM-88 has strong interrater reliability (ICC = 0.9
次要结局
- Incidence of gross motor milestone achievement, by parent report(From date of randomization at each documented progression until child takes three independent steps, assessed up to 36 months.)
研究者
Megan Flores
Assistant Professor
University of St. Augustine for Health Sciences