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Clinical Trials/CTRI/2025/01/079707
CTRI/2025/01/079707Not yet recruitingNot Applicable

Development and Validation of an Assessment tool for evaluation of Children with disabilities in the Community

Sidhiprada Mohapatra1 site in 1 country30 target enrollmentStarted: February 7, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
For content validation:

Study Overview

Brief Summary

This study aims to create and validate an assessment tool specifically designed for children with disabilities (CWD) in community settings. The tool will cover important areas such as body structure and function, activity limitations, participation restrictions, and contextual factors, based on the International Classification of Functioning, Disability, and Health for Children and Youth (ICF-CY).

The research will be conducted in three stages: developing the tool, refining it with input from experts, and testing its reliability and validity by comparing it with an established gold-standard tool. The study will involve children with disabilities (aged 0-15 years, focusing on locomotor and neurodivergent conditions) and experts in the field. The outcomes are anticipated to enhance long-term intervention planning for children with disabilities, benefiting both individuals and society.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Year(s) to 15.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • For Content Validation: Experts with at least 1 year of experience in treating children with disabilities.
  • Availability to commit time to assess the assessment form.
  • For Concurrent validation and Reliability: Children with locomotor and neurodivergent disabilities that include- Cerebral palsy, Muscular dystrophy, Spina bifida, Down syndrome, Attention-deficit/hyperactivity disorder, Specific learning disabilities, Intellectual disability.

Exclusion Criteria

  • Children with mental illness, Children without disabilities, Children above the age of 15 years.

Outcomes

Primary Outcomes

For content validation:

Time Frame: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

Content Validation Index (CVI) (which is set at 0.80)

Time Frame: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

For Inter-rater Reliability of the assessment tool:

Time Frame: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

Intra-class correlation coefficient (ICC) values among the investigators administering the tool.

Time Frame: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

Secondary Outcomes

  • Proportion of items retained after expert review & Likert scale scoring (80%)

Investigators

Sponsor
Sidhiprada Mohapatra
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Ancilla Blessy Verghese

Manipal College of Health Professions, Manipal

Study Sites (1)

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