Clinical Trials Directory

Trials / Unknown

UnknownNCT06164145

Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors

Status
Unknown
Phase
Study type
Observational
Enrollment
125 (estimated)
Sponsor
Khon Kaen University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The type of the study is an observational study to test in stroke survivors. The main questions it aims to answer are 1. What is a Burmese version, content validity, convergent validity, divergent validity, and reliability of SF-36 questionnaire in stroke survivors? 2. Does the Burmese version of SF-36 have the responsiveness in stroke survivors? Participants will be interviewed the questionnaire by the research team.

Detailed description

Cross-cultural adaptation of a subjective questionnaire is required for use in a different country, culture, and/or language. Although the majority of questionnaires were created in English-speaking nations, researchers must nonetheless take into account non-native populations in health studies, particularly when their omission could result in a systematic bias in studies of health care usage (Beaton et al., 2000). For the purpose of translating and culturally adapting, it is crucial to achieve equality between the target and original sources of the questionnaire. As it relates to the authors' perspective, the Short Form 36 (SF-36) has not yet been translated and cross-culturally adapted to be used in Myanmar. As a result, the features of a Burmese version's reliability and validity among individuals with a history of stroke have not been studied in the previous research work. In addition, the questionnaire should also be tested for its responsiveness to provide clinical meaningful for health care professions. Therefore, the aim of this study is to develop a Burmese version of the SF-36 (SF-36-Burmese) according to translation and cross-cultural adaption guidelines and evaluate its reliability, validity, and responsiveness (i.e., the instrument's capacity to identify changes over time in the construct being assessed) and the minimum clinical important difference (MCID, ie., the smallest change in an outcome that a patient would perceive as clinically meaningful) among stroke survivors.

Conditions

Interventions

TypeNameDescription
OTHERUsual careThe training program used in this study is the stroke rehabilitation program focusing on health education for stroke and a routine exercise program based on the National Strategic Plan for Stroke Rehabilitation in Myanmar.

Timeline

Start date
2023-12-30
Primary completion
2024-12-30
Completion
2024-12-30
First posted
2023-12-11
Last updated
2024-03-06

Locations

1 site across 1 country: Burma

Source: ClinicalTrials.gov record NCT06164145. Inclusion in this directory is not an endorsement.