Clinical trial NCT05405517: Translation of Modified Fatigue Impact Scale in Urdu Language
Official title: Translation and Cross Cultural Validation on Modified Fatigue Impact Scale in Urdu Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Fatigue, TBI
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic Brain Injury

Brief 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.

Detailed 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Modified Fatigue impact scale
timeFrame: 8 months
Secondary outcomes:
measure: Reliability of translated versions of MFIS
timeFrame: 8 months
measure: Validity of translated versions of MFIS
timeFrame: 8 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Tehreem Mukhtar
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tehreem Mukhtar, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiehser DM, Delano-Wood L, Jak AJ, Matthews SC, Simmons AN, Jacobson MW, Filoteo JV, Bondi MW, Orff HJ, Liu L. Validation of the Modified Fatigue Impact Scale in mild to moderate traumatic brain injury. J Head Trauma Rehabil. 2015 Mar-Apr;30(2):116-21. doi: 10.1097/HTR.0000000000000019.
citation: Ziino C, Ponsford J. Measurement and prediction of subjective fatigue following traumatic brain injury. J Int Neuropsychol Soc. 2005 Jul;11(4):416-25. doi: 10.1017/s1355617705050472.
citation: Khalil H, Al-Shorman A, Alghwiri AA, Abdo N, El-Salem K, Shalabi S, Aburub A. Cross cultural adaptation and psychometric evaluation of an Arabic version of the modified fatigue impact scale in people with multiple sclerosis. Mult Scler Relat Disord. 2020 Apr;39:101878. doi: 10.1016/j.msard.2019.101878. Epub 2019 Nov 29.
citation: Hebert JR, Forster JE, Stearns-Yoder KA, Penzenik ME, Brenner LA. Persistent Symptoms and Objectively Measured Balance Performance Among OEF/OIF Veterans With Remote Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2018 Nov/Dec;33(6):403-411. doi: 10.1097/HTR.0000000000000385.