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NCT Number: NCT06943352

Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome

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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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Box and Block test

Time frame: 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

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome Children

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 24, 2025
Registry last updated: Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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