Foot InjuriesNCT05997797
Translation and Reliability of FAAM-U
An observational study of Foot Injuries and Ankle Injuries, run by University of Lahore at 1 site in Pakistan.
Trial summary
This study is designed to translate and validate the FAAM questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. Read more about this study
- Who is it for?
- Ages 16 to 44 years
- Conditions the study is for
- Foot Injuries, Ankle Injuries
- What is being tested?
- FAAM
- How many people
- 175 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jul 2022to 15 Nov 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 16 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: With a time, span of 3 days after the primary recording, a total of the 175 patients whose conditions were relied upon to stay stable were approached to complete the forms again in the retest meeting; no treatment was given during this time-frame.
Who may be able to join
- Ankle and foot disorders, referred by a general physician or surgeon,
- Conscious
- Ambulatory
- Able to write and read Urdu language
Who cannot join
- inflammatory disease
- vascular diseases
- neural diseases
- cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation, Cross-Cultural Adaptation and Reliability of Urdu Version of The Foot and Ankle Ability Measures (FAAM-U)
This study is designed to translate and validate the FAAM questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.
- Conditions
- Foot Injuries, Ankle Injuries
- Being tested
- FAAM
- Medical subject headings
- Foot Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAAMOther
The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually
| Study group | Role | What they receive |
|---|---|---|
| Single Group | A total of 175 patients with a range of foot or ankle problems were included for the review. Informed consent was taken from the review members in written form. They all finished the Urdu version of FAAM in the test session. With a time, span of 3 days after the primary recording, a total of the 175 patients whose conditions were relied upon to stay stable were approached to complete the forms again in the retest meeting; no treatment was given during this time-frame. The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale. Patients evaluated everything as indicated by the trouble they go over with each undertaking on account of their foot or ankle condition. After assortment, information was saved in a safe spot to keep away from any dispositions. Receives: Other: FAAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAAM-U
The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale
Measured: 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start2 Jul 2022
- Primary completion7 Sep 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Foot InjuriesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997797
- Sponsor's protocol ID
- IRB- UOL-FAHS/810-XXII/2021
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guyatt GH, Sackett DL, Sinclair JC, Hayward R, Cook DJ, Cook RJ. Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA. 1995 Dec 13;274(22):1800-4. doi: 10.1001/jama.274.22.1800. No abstract available.
PubMed 7500513Cervera-Garvi P, Ortega-Avila AB, Morales-Asencio JM, Cervera-Marin JA, Martin RR, Gijon-Nogueron G. Cross-cultural adaptation and validation of Spanish version of The Foot and Ankle Ability Measures (FAAM-Sp). J Foot Ankle Res. 2017 Aug 22;10:39. doi: 10.1186/s13047-017-0221-6. eCollection 2017.
PubMed 28852426Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.
PubMed 18345343Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
PubMed 17161752Martin RL, Irrgang JJ. A survey of self-reported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007 Feb;37(2):72-84. doi: 10.2519/jospt.2007.2403.
PubMed 17366962Cuesta-Vargas AI, Gabel CP, Bennett P. Cross cultural adaptation and validation of a Spanish version of the Lower Limb Functional Index. Health Qual Life Outcomes. 2014 May 17;12:75. doi: 10.1186/1477-7525-12-75.
PubMed 24885123Nelson EC, Eftimovska E, Lind C, Hager A, Wasson JH, Lindblad S. Patient reported outcome measures in practice. BMJ. 2015 Feb 10;350:g7818. doi: 10.1136/bmj.g7818. No abstract available.
PubMed 25670183Cuesta-Vargas AI, Gabel PC. Cross-cultural adaptation, reliability and validity of the Spanish version of the Upper Limb Functional Index. Health Qual Life Outcomes. 2013 Jul 26;11:126. doi: 10.1186/1477-7525-11-126.
PubMed 23889883Forget NJ, Higgins J. Comparison of generic patient-reported outcome measures used with upper extremity musculoskeletal disorders: linking process using the International Classification of Functioning, Disability, and Health (ICF). J Rehabil Med. 2014 Apr;46(4):327-34. doi: 10.2340/16501977-1784.
PubMed 24531349De Noronha M, Refshauge KM, Kilbreath SL, Figueiredo VG. Cross-cultural adaptation of the Brazilian-Portuguese version of the Cumberland Ankle Instability Tool (CAIT). Disabil Rehabil. 2008;30(26):1959-65. doi: 10.1080/09638280701809872.
PubMed 18720109Martin RL, Hutt DM, Wukich DK. Validity of the Foot and Ankle Ability Measure (FAAM) in Diabetes Mellitus. Foot Ankle Int. 2009 Apr;30(4):297-302. doi: 10.3113/FAI.2009.0297.
PubMed 19356352Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Bago d'Uva T, Van Doorslaer E, Lindeboom M, O'Donnell O. Does reporting heterogeneity bias the measurement of health disparities? Health Econ. 2008 Mar;17(3):351-75. doi: 10.1002/hec.1269.
PubMed 17701960Lin CI, Houtenbos S, Lu YH, Mayer F, Wippert PM. The epidemiology of chronic ankle instability with perceived ankle instability- a systematic review. J Foot Ankle Res. 2021 May 28;14(1):41. doi: 10.1186/s13047-021-00480-w.
PubMed 34049565Lopez-Lopez D, Perez-Rios M, Ruano-Ravina A, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Romero-Morales C, Calvo-Lobo C, Navarro-Flores E. Impact of quality of life related to foot problems: a case-control study. Sci Rep. 2021 Jul 15;11(1):14515. doi: 10.1038/s41598-021-93902-5.
PubMed 34267276
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-Cultural Adaptation and Reliability of Urdu Version of The Foot and Ankle Ability Measures (FAAM-U)
- ClinicalTrials.gov ID
- NCT05997797
- Acronym / sponsor ID
- IRB- UOL-FAHS/810-XXII/2021
- Conditions
- Foot Injuries, Ankle Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 18 Aug 2023 (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.
This study is designed to translate and validate the FAAM questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | Other: FAAMA total of 175 patients with a range of foot or ankle problems were included for the review. Informed consent was taken from the review members in written form. They all finished the Urdu version of FAAM in the test session. With a time, span of 3 days after the primary recording, a total of the 175 patients whose conditions were relied upon to stay stable were approached to complete the forms again in the retest meeting; no treatment was given during this time-frame. The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale. Patients evaluated everything as indicated by the trouble they go over with each undertaking on account of their foot or ankle condition. After assortment, information was saved in a safe spot to keep away from any dispositions. |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- With a time, span of 3 days after the primary recording, a total of the 175 patients whose conditions were relied upon to stay stable were approached to complete the forms again in the retest meeting; no treatment was given during this time-frame.
Key inclusion criteria (4 listed)
- Ankle and foot disorders, referred by a general physician or surgeon,
- Conscious
- Ambulatory
- Able to write and read Urdu language
Key exclusion criteria (4 listed)
- inflammatory disease
- vascular diseases
- neural diseases
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAAMThe FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually | Other | Single Group |
Primary outcome
FAAM-U
Time frame: 72 Hours
The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale
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 18 Aug 2023.
- Background: PubMed 7500513Guyatt GH, Sackett DL, Sinclair JC, Hayward R, Cook DJ, Cook RJ. Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA. 1995 Dec 13;274(22):1800-4. doi: 10.1001/jama.274.22.1800. No abstract available.
- Background: PubMed 28852426Cervera-Garvi P, Ortega-Avila AB, Morales-Asencio JM, Cervera-Marin JA, Martin RR, Gijon-Nogueron G. Cross-cultural adaptation and validation of Spanish version of The Foot and Ankle Ability Measures (FAAM-Sp). J Foot Ankle Res. 2017 Aug 22;10:39. doi: 10.1186/s13047-017-0221-6. eCollection 2017.
- Background: PubMed 18345343Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.
- Background: PubMed 17161752Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
- Background: PubMed 17366962Martin RL, Irrgang JJ. A survey of self-reported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007 Feb;37(2):72-84. doi: 10.2519/jospt.2007.2403.
- Background: PubMed 24885123Cuesta-Vargas AI, Gabel CP, Bennett P. Cross cultural adaptation and validation of a Spanish version of the Lower Limb Functional Index. Health Qual Life Outcomes. 2014 May 17;12:75. doi: 10.1186/1477-7525-12-75.
- Background: PubMed 25670183Nelson EC, Eftimovska E, Lind C, Hager A, Wasson JH, Lindblad S. Patient reported outcome measures in practice. BMJ. 2015 Feb 10;350:g7818. doi: 10.1136/bmj.g7818. No abstract available.
- Background: PubMed 23889883Cuesta-Vargas AI, Gabel PC. Cross-cultural adaptation, reliability and validity of the Spanish version of the Upper Limb Functional Index. Health Qual Life Outcomes. 2013 Jul 26;11:126. doi: 10.1186/1477-7525-11-126.
- Background: PubMed 24531349Forget NJ, Higgins J. Comparison of generic patient-reported outcome measures used with upper extremity musculoskeletal disorders: linking process using the International Classification of Functioning, Disability, and Health (ICF). J Rehabil Med. 2014 Apr;46(4):327-34. doi: 10.2340/16501977-1784.
- Background: PubMed 18720109De Noronha M, Refshauge KM, Kilbreath SL, Figueiredo VG. Cross-cultural adaptation of the Brazilian-Portuguese version of the Cumberland Ankle Instability Tool (CAIT). Disabil Rehabil. 2008;30(26):1959-65. doi: 10.1080/09638280701809872.
- Background: PubMed 19356352Martin RL, Hutt DM, Wukich DK. Validity of the Foot and Ankle Ability Measure (FAAM) in Diabetes Mellitus. Foot Ankle Int. 2009 Apr;30(4):297-302. doi: 10.3113/FAI.2009.0297.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Foot Injuries and Ankle Injuries, run by University of Lahore 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 4 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 18 Aug 2023. 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?
FAAM-U (time frame: 72 Hours). 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 NCT05997797, which also lists 31 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 18 Aug 2023.