An Investigation of Trunk Control in Young Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Segmental Assessment of Trunk Control
研究概览
简要总结
Overall, the purpose of this dissertation research is to investigate trunk control in young children with DS. This will be done in three studies:
- The purpose of the first study is to determine the reliability of the SATCo in young children with DS. The hypothesis is that the SATCo will demonstrate good (κ > 0.8) interrater and intrarater reliability.
- The purpose of the second study is to examine the validity of the SATCo with the GMFM-66 and determine whether age and SATCo score predict GMFM-66 score in young children with DS. The hypotheses are that 1) the SATCo will show concurrent validity with the GMFM-66, and 2) both age and SATCo scores will be significant predictors of GMFM-66 scores.
- The purpose of the third study is to explore the impact of a dynamic standing device (Upsee) on trunk control and motor skills in young children with DS. The hypothesis is that participants will demonstrate a greater change in scores on the SATCo and the GMFM during the dynamic standing home program phase than during the baseline phases.
详细描述
Literature suggests there is a need to identify effective home programs to supplement physical therapy and improve gross motor function in children with Down syndrome (DS). To study the impact of home programs, effective tools must be employed to measure the incremental changes that occur in young children with DS, both at the body structure and function level and the activity level of the World Health Organization's International Classification of Functioning, Disability and Health (ICF). The Gross Motor Function Measure (GMFM-66) is an effective measure of motor skills at the activity level of the ICF for children with DS; however, there is a lack of sound outcome measures of trunk control for young children with DS. The Segmental Assessment of Trunk Control (SATCo) may be an effective tool for this purpose but has not been studied in this population.
In addition to assessing trunk control in children with DS, intervention strategies for improving trunk control in this population must be investigated. A home program using upright mobility through treadmill training has proven to be effective in accelerating the acquisition of motor skills in infants with DS; however, alternative forms of upright mobility that are more affordable and less cumbersome are needed. The Upsee (Firefly by Leckey, Lisburn, Northern Ireland) shows promise as a dynamic standing device that can be used at home by the parent and child to promote upright mobility. This device has not been studied in young children with DS.
Overall, the purpose of this dissertation research is to investigate trunk control in young children with DS. This will be done in three studies:
- The purpose of the first study is to determine the reliability of the SATCo in young children with DS. The hypothesis is that the SATCo will demonstrate good (κ > 0.8) interrater and intrarater reliability.
- The purpose of the second study is to examine the validity of the SATCo with the GMFM-66 and determine whether age and SATCo score predict GMFM-66 score in young children with DS. The hypotheses are that 1) the SATCo will show concurrent validity with the GMFM-66, and 2) both age and SATCo scores will be significant predictors of GMFM-66 scores.
- The purpose of the third study is to explore the impact of a dynamic standing device (Upsee) on trunk control and motor skills in young children with DS. The hypothesis is that participants will demonstrate a greater change in scores on the SATCo and the GMFM during the dynamic standing home program phase than during the baseline phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DS. This is the diagnosis that is being investigated
- •Speak English. This is the language spoken by the PI.
- •Medically stable, without physician- ordered restrictions. Some children with DS have cardiac surgery or other complications that would contraindicate handling or movement. These children would not be considered medically stable.
- •Between the age of 6 to 24 months. This captures the full range of the outcome measure being investigated.
排除标准
- •Meet inclusion and exclusion criteria for part 1 of the study. Children for part 2 of the study will be a sub-sample of those in part 1 of the study.
- •Between the age of 9 to 18 months. This captures the age when most children with DS are able to bear weight through their lower extremities, but before they can walk independently. This is necessary to be able to use the home programs and demonstrate gross motor changes.
- •Unable to ambulate independently. Children who can walk independently cannot use the home program devices.
研究组 & 干预措施
Dynamic Standing Device
Home program using the Upsee
干预措施: Physical Therapy Home Program (Other)
结局指标
主要结局
Segmental Assessment of Trunk Control
时间窗: 20 minutes
Assesses seated trunk control in children with neuromotor disorders.
Gross Motor Function Measure
时间窗: 40 minutes
Assesses gross motor skills in children with Down syndrome
次要结局
未报告次要终点