Translation of Modified Fatigue Impact Scale in Urdu Language

Study Overview
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Brief Summary
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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.

Detailed Description
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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.)

Official Title
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Translation and Cross Cultural Validation on Modified Fatigue Impact Scale in Urdu Language

Conditions
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Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age 18-65 years Both Male and Female Patient Able to read Urdu Language Any period of loss of consciousness after 1 hour of injury Patients who can actively participate in community For comprehension patients with the MMSE score > 25 will be included Exclusion Criteria: Patients able to perform 5 meter walk test Patients having score >6 in FIM scale For alcohol abuse patients with the score < 8 in AUDIT scale Any other neurological disease including Alzheimer, Parkinson's disease and Schizophrenia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue impact scale | The modified fatigue impact scale consists of 21 questions. The version of MFIS questionnaire is divided into 3 subdivision containing 9 physical items , 10 cognitive items and 2 psychosocial. All the items are rated from 0-4 . The sum of all the questions are calculated where 84 is the highest score. Highest the score means higher the impact of fatigue in daily living. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of translated versions of MFIS | To determine the reliability of cross-culturally adapted and translated MFIS in the patients with TBI .Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two intervals between different visits of the patient. Intra class correlation coefficient(ICC) will be determine for test retest reliability. | 8 months | 
| Validity of translated versions of MFIS | To determine the validity of cross-culturally adapted and translated MFIS in the patients with TBI. Validity is how accurate the results are. Thus this will be measured through various parameters to validate the translated versions as appropriate and applicable. Pearson correlation coefficient was used to find convergent validity. CVI will detremine to find Content Validity for Urdu translated tool. validity | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, TBI