Clinical trial NCT06164145: Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors
Official title: Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Satisfaction
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemiplegic patients who will be treated at inpatient ward of Department of Physical Medicine and Rehabilitation

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and above (Coppers et al., 2021; Soto-Vidal et al., 2021; Wayessa et al., 2023)
2. Hemiplegia induced by both ischemic and hemorrhagic stroke at least 1 month duration (Wayessa et al., 2023; Vincent-Onabajo, Owolabi \& Hamzat, 2014)
3. Ability to understand the study and respond to questions (on the Mini- Mental State Examination \> 23) (Wongchaisuwan et al., 2005; Muangpaisan et al., 2015)
4. Stable medical conditions

Exclusion Criteria:

1. Other neurological diseases such as Parkinson's disease, dementia, Alzheimer's disease, peripheral neuropathy according to medical history and record
2. Recurrent stroke
3. Participants with dysphasia, intellectual impairments, traumatic head injury, and psychiatric diseases (Wayessa et al., 2023)

3) Participants who cannot understand Burmese language

Primary outcomes:
measure: Short Form 36
timeFrame: Baseline-1 week-4th week
Secondary outcomes:
measure: Patient Reported Outcome Measurement System (PROMIS-29)
timeFrame: Baseline-1 week
measure: Berg Balance Scale (BBS)
timeFrame: Baseline-1 week
measure: Barthel Index (BI)
timeFrame: Baseline-1 week
measure: Global Rating of Change (GRC) Scale
timeFrame: Baseline-1 week-4th week
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Yangon General Hospital
Study officials:
affiliation: Khon Kaen University
name: Myitzu Khin Khin, Master
role: PRINCIPAL_INVESTIGATOR
References: