MedDataX Logo

Translation of Modified Fatigue Impact Scale in Urdu Language

NCT ID: NCT05405517

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fatigue, TBI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tehreem Mukhtar, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tehreem Mukhtar

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24413076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16209422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31841967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29385020 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Fariha Zulfiqar

Identifier Type: -

Identifier Source: org_study_id