Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2025-07-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized clinical trial will be performed. Participants of this group will play in a group with sensory bins with other children. The intervention will help children interact with others in society and for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. 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.

Drawing and painting are involved in free play. Participants of group will play alone. The participants will draw or paint for improving manual dexterity. According to FITT Principle, the intervention will be given 3 days a week for 12 weeks and alternate days will be selected. After every 2 weeks, the tasks will be upgraded. The interventions will be given for 45 minutes in each session.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment

Study Groups

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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.

Group Type EXPERIMENTAL

Sensory Bins

Intervention Type OTHER

The sensory bin is a basket filled with different objects of different shapes, sizes, and textures.

Drawing and Painting

Intervention Type OTHER

Colored pencils and watercolors will be used.

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.

Group Type ACTIVE_COMPARATOR

Drawing and Painting

Intervention Type OTHER

Colored pencils and watercolors will be used.

Interventions

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Sensory Bins

The sensory bin is a basket filled with different objects of different shapes, sizes, and textures.

Intervention Type OTHER

Drawing and Painting

Colored pencils and watercolors will be used.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with moderate level of mental retardation who are able to follow commands

Exclusion Criteria

* • Children with other musculoskeletal and neurological issues.

* Children with down syndrome but also have complications such as epilepsy, congenital heart condition.

Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No