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Clinical Trial Summary

Cross cultural analytical study to translate Modified fatigue impact scale MFIS) in Urdu language. Along with the translated version by evaluating its validity and reliability among the patients of traumatic brain injury. No such study has been previously conducted in Pakistan which translate this scale in Urdu and follows the proper cross- culture adaptation.Condition or disease: Traumatic brain injury. Convenient sampling technique would be used.


Clinical Trial Description

The MFIS is a modified version of 40-item Fatigue Impact Scale (FIS). The MFIS impact scale consist of 3 subdivisions containing 9 physical items , 10 cognitive items and 2 psychosocial. The maximum score is 84 which is obtained by the sum of all the questions The higher score means high impact on quality of life. This version should be answered by the patients with traumatic brain injury. It is the patient's self- report. As the MFIS is well- developed measurement scale, it is meaningful to translate and validate this scale in Urdu Version. It is useful the study the effect of fatigue in the patients with TBI by using same measurement items so that a more direct comparison can be made. Therefore, the aim of the study is to translate and validate the Modified Fatigue Impact scale in Urdu language The translation and cultural adaptation process would start after obtaining approval from the developer of the original MFIS. This would be done according to WHO guidelines. Translation will be done by symmetrical category. The purpose will be to gain uniformity in the translation of tool in both the Target language and source language. This will involve 5 steps. (Forward translation, synthesis 2, Backward translation, synthesis 2 and pilot testing). Phase 2 would be done according to the guidelines of COSMIN in which psychometric properties will be measured.(reliability, internal consistency, construct validity and factor analysis.) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05405517
Study type Observational
Source Riphah International University
Contact
Status Completed
Phase
Start date May 15, 2021
Completion date July 30, 2022

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