Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Box and Block test
研究概览
简要总结
Down Syndrome is a genetic condition in which a patient has an extra chromosome which is a copy of chromosome 21. It causes physical, cognitive, and behavioral symptoms. The person has difficulty with normal life activities. This study evaluates the effect of interactive sensory play on coordinated hand movements or manual dexterity in children with Down Syndrome. Down syndrome is one of the most common birth defects and causes impairments in the body. The children diagnosed with Down syndrome need great deal of therapies in early childhood so that can live a better life. The objective of this study is to assess the effects of interactive sensory play on manual dexterity in Down syndrome children.
The study design will be a Randomized Controlled Trial. The study setting will be Tehsil Headquater hospital Sadiqabad. The study duration will be 10 months after the approval of the synopsis. The Sample Size will be 22 which is calculated by epitools. The sampling technique will be a Non-probability convenient sampling technique. Children who are diagnosed with Down Syndrome will be included. Children with other musculoskeletal and neurological issues will be excluded. Data Collection Tools will be Box and Block test and Pediatric Evaluation of Disability Inventory. Identification and recruitment of the participants with Down syndrome will be done. Participants will be selected through lottery for both groups. Group 1 will use Interactive Sensory play and Group 2 will use Free Play as intervention. The assessor will be blind. The data will be analyzed using SPSS 23.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with moderate level of mental retardation who are able to follow commands
排除标准
- •• Children with other musculoskeletal and neurological issues.
- •Children with down syndrome but also have complications such as epilepsy, congenital heart condition.
研究组 & 干预措施
Interactive Sensory play with Free Play Group
Participants of this group will play in a group with sensory bins with other children. The sensory bin is a basket filled with different objects of different shapes, sizes, and textures. The intervention will help children interact with others in society and for improving manual dexterity. The children play in group and alone also for this group.
According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The free play will be given for 15 minutes and interactive sensory play will be given for 30 minutes. The interventions will be given for 45 minutes in each session.
干预措施: Sensory Bins (Other)
Interactive Sensory play with Free Play Group
Participants of this group will play in a group with sensory bins with other children. The sensory bin is a basket filled with different objects of different shapes, sizes, and textures. The intervention will help children interact with others in society and for improving manual dexterity. The children play in group and alone also for this group.
According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The free play will be given for 15 minutes and interactive sensory play will be given for 30 minutes. The interventions will be given for 45 minutes in each session.
干预措施: Drawing and Painting (Other)
Free Play Group
Drawing and painting are involved in free play. Participants of this group will play alone. The participants will draw or paint for improving manual dexterity. According to the FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. At first, small and easy tasks will be given and after every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session.
干预措施: Drawing and Painting (Other)
结局指标
主要结局
Box and Block test
时间窗: At the start as baseline data. Again at 6th week and then finally at 12th week.
This test is used to measure manual dexterity. This test is simple, cheap and quick. The test can be used for different populations to assess the coordinated movements of the hands. The test-retest reliability on more weak hand is 0.98 and the less weak hand is 0.93.It has good convergent validity as the value is 0.80.
• Pediatric Evaluation of Disability Inventory
时间窗: At the start as baseline data. Again at 6th week and then finally at 12th week.
This is an interviewing tool to assess the independence of the patients to perform different activities using their hands. The reliability that was seen was ranging from 0.18 to 0.94. The value of construct validity was seen to be ranging from 0.64-0.95.
Nine-Hole Peg Test
时间窗: At the start as baseline data. Again at 6th week and then finally at 12th week.
This test is used to assess manual dexterity. This test is easy, simple and quick. This test assess coordinated movements of hands. This test consists of a board with nine holes and square boxes or pegs which are inserted into the holes by the participants. This test can be used for assessment in every population. It has excellent interrater reliability which is equal to 0.75 to 0.99. It has excellent convergent validity that is equal to 0.82.
次要结局
未报告次要终点