Translation of Modified Fatigue Impact Scale in Urdu Language

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Fatigue Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tehreem Mukhtar

Lahore, Punjab Province, 54000, Pakistan

About this study

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.)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Reliability of translated versions of MFIS

Time frame: 8 months

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.
Validity of translated versions of MFIS

Time frame: 8 months

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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 6, 2022
Registry last updated: Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed