Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome

Sponsor
Riphah International University
Study ID
NCT06943352
Status
Not Yet Recruiting

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Conditions

  • Down Syndrome

Eligibility Criteria

Sex
ALL
Age
8 Years - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • Sensory Bins — OTHER
    The sensory bin is a basket filled with different objects of different shapes, sizes, and textures.
  • Drawing and Painting — OTHER
    Colored pencils and watercolors will be used.

Study Details

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.

Key Dates

First listed
Apr 24, 2025
Start date
Apr 15, 2025
Status verified
Apr 2025
Primary completion
Apr 15, 2025
Completion
Jul 16, 2025

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Box and Block test [ Time Frame: At the start as baseline data. Again at 6th week and then finally at 12th week. ]

Central Contacts

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