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临床试验/CTRI/2025/01/079707
CTRI/2025/01/079707尚未招募不适用

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

Sidhiprada Mohapatra1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
For content validation:

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

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

结局指标

主要结局

For content validation:

时间窗: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

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

时间窗: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

For Inter-rater Reliability of the assessment tool:

时间窗: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

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

时间窗: Content Validation: Baseline | Inter-rater reliability: Rater centric timepoints

次要结局

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

研究者

发起方
Sidhiprada Mohapatra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ancilla Blessy Verghese

Manipal College of Health Professions, Manipal

研究点 (1)

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