Traumatic Brain InjuryNCT05405517
Translation of Modified Fatigue Impact Scale in Urdu Language
An observational study of Traumatic Brain Injury, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2021to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Traumatic Brain Injury
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Cross Cultural Validation on 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.
Read the 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.)
- Conditions
- Traumatic Brain Injury
- Keywords
- Fatigue, TBI
- Medical subject headings
- Brain Injuries, Traumatic, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (2)
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.
Measured: 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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start15 May 2021
- Primary completion15 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405517
- Sponsor's protocol ID
- Fariha Zulfiqar
- Status last verified
- Dec 2022
- First submitted
- 28 Apr 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24413076Ziino 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.
PubMed 16209422Khalil 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.
PubMed 31841967Hebert 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.
PubMed 29385020
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Cross Cultural Validation on Modified Fatigue Impact Scale in Urdu Language
- ClinicalTrials.gov ID
- NCT05405517
- Acronym / sponsor ID
- Fariha Zulfiqar
- Conditions
- Traumatic Brain Injury
- Keywords
- Fatigue, TBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Traumatic Brain Injury
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Reliability of translated versions of MFIS
Time frame: 8 months
Validity of translated versions of MFIS
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 24413076Schiehser 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.
- Background: PubMed 16209422Ziino 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.
- Background: PubMed 31841967Khalil 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.
- Background: PubMed 29385020Hebert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tehreem Mukhtar, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue impact scale (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405517, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.