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Not yet recruiting NCT06943352

Effects of Interactive Sensory Play on Manual Dexterity in Down Syndrome

No phase Interventional Down Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sensory Bins, Drawing and Painting.
Who it may be relevant to
Registry conditions: Down Syndrome. Basic parameters: 8 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Box and Block test [Time frame: At the start as baseline data. Again at 6th week and then finally at 12th week.]
  • • Pediatric Evaluation of Disability Inventory [Time frame: At the start as baseline data. Again at 6th week and then finally at 12th week.]
  • Nine-Hole Peg Test [Time frame: At the start as baseline data. Again at 6th week and then finally at 12th week.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Jarusriboonchai P, Meissner JL, Almeida T, Balaam M. Understanding children's free play in primary schools. InProceedings of the 9th International Conference on Communities & Technologies-Transforming Communities 2019 Jun 3 (pp. 178-188).

Identifiers

NCT: NCT06943352 · REC/RCR/AHS/25/taiba hussain

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗