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Clinical Trials/NCT05405517
NCT05405517
Completed
N/A

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

Riphah International University1 site in 1 country105 target enrollmentMay 15, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Riphah International University
Enrollment
105
Locations
1
Primary Endpoint
Modified Fatigue impact scale
Status
Completed
Last Updated
3 years ago

Overview

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.)

Registry
clinicaltrials.gov
Start Date
May 15, 2021
End Date
July 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

Modified Fatigue impact scale

Time Frame: 8 months

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.

Secondary Outcomes

  • Validity of translated versions of MFIS(8 months)
  • Reliability of translated versions of MFIS(8 months)

Study Sites (1)

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