The Effects of Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Fine Motor Skills, Activity and Participation Limitations in Children With Down Syndrome: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- performance quality rating scale
研究概览
简要总结
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week in the cross-over randomized study. Following 12-week wash-out period, interventions will be changed for each group.
详细描述
Down syndrome (DS) is a chromosomal anomaly characterized by the presence of an extra copy of genetic material on the 21st chromosome. Sensory, motor, cognitive and perceptual impairments can be seen in children with DS. These impairments probably affect the development and learning of their various fundamental and complex actions. Those children experience decreased motor proficiency, reduced social participation and lower life quality.
Fine motor skills are important for children's everyday functioning such as dressing, feeding, bathing, holding objects, cutting etc. In addition, fine motor skills are related to cognitive, social and academic abilities in children.
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included.
Random allocation software will be used to assign CO-OP or CE to participants. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week. Both intervention will be applied as groups including 3-4 children. Following 12-week wash-out period, interventions will be changed for each group. Two meetings before and during the study will be done in order to inform parents about the interventions and their effects. Another investigator who is blind about the groups will conduct the assessments before and after both first and second treatment durations so 4 assessments will be done in total. At the end of whole treatment schedule, a satisfaction form will be asked from the parents for feedback about both interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 7 and 18 years
- •Children who can understand cognitive skills given and can verbally communicate
- •Children who can specify at least 3 activities
- •Children who have adequate motivation
排除标准
- •Caregivers or parents who have inadequate cognitive levels for the study progression
- •Children who participate in any physiotherapy/ergo-therapy schedules for at least 3 months
- •Children who have Cognitive Orientation to daily Occupational Performance and Conductive Education program.
- •Children who have other neurological problems (except Down Syndrome)
- •Children who have undergone orthopedic surgery related to upper limbs
- •Children who have other health and behavioral problems which can affect the participation in the study
结局指标
主要结局
performance quality rating scale
时间窗: 12 weeks
The PQRS rates performance quality on a 10-point scale, with a score of 1 indicating ''can't do the skill at all'' and 10 indicating ''does the skill very well''. An independent observer rates performances from video recorded trials of each skill at all assessment points.
次要结局
- Bruininks-Oseretsky Motor Proficiency Test - Brief Form(12 weeks)
- Goal Attainment Scaling(12 weeks)
- Parent Satisfaction Form(12 weeks)
- Nine Hole Peg Test(12 weeks)
- Dynamic Performance Analysis(12 weeks)
- Canadian Occupational Performance Measure(12 weeks)
- Child Health Questionnaire- Parent Form(12 weeks)
研究者
Hülya Özbeşer
PT. Ms
Eastern Mediterranean University