Translation and Reliability of FAAM-U

NCT ID: NCT05997797

Last Updated: 2023-08-18

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

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-02

Study Completion Date

2022-11-15

Brief Summary

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

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.

Detailed Description

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

Conditions

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

Foot Injuries Ankle Injuries

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

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

FAAM

Intervention Type OTHER

The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FAAM

The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Ankle and foot disorders, referred by a general physician or surgeon,
* Conscious
* Ambulatory
* Able to write and read Urdu language

Exclusion Criteria

* inflammatory disease
* vascular diseases
* neural diseases
* cancer
Minimum Eligible Age

16 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University of Lahore

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

Locations

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

The University of Lahore

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.

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.

Reference Type BACKGROUND
PMID: 7500513 (View on PubMed)

Cervera-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.

Reference Type BACKGROUND
PMID: 28852426 (View on PubMed)

Carcia 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.

Reference Type BACKGROUND
PMID: 18345343 (View on PubMed)

Terwee 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.

Reference Type BACKGROUND
PMID: 17161752 (View on PubMed)

Martin 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.

Reference Type BACKGROUND
PMID: 17366962 (View on PubMed)

Cuesta-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.

Reference Type BACKGROUND
PMID: 24885123 (View on PubMed)

Nelson 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.

Reference Type BACKGROUND
PMID: 25670183 (View on PubMed)

Cuesta-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.

Reference Type BACKGROUND
PMID: 23889883 (View on PubMed)

Forget 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.

Reference Type BACKGROUND
PMID: 24531349 (View on PubMed)

De 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.

Reference Type BACKGROUND
PMID: 18720109 (View on PubMed)

Martin 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.

Reference Type BACKGROUND
PMID: 19356352 (View on PubMed)

Beaton 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.

Reference Type BACKGROUND
PMID: 11124735 (View on PubMed)

Bago 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.

Reference Type BACKGROUND
PMID: 17701960 (View on PubMed)

Lin 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.

Reference Type BACKGROUND
PMID: 34049565 (View on PubMed)

Lopez-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.

Reference Type BACKGROUND
PMID: 34267276 (View on PubMed)

Saleh, A.M., et al., PSYCHOMETRIC PROPERTIES OF TRANSLATED ARABIC VERSION OF FOOT AND ANKLE ABILITY MEASURE QUESTIONNAIRE. 32: p. 3.

Reference Type BACKGROUND

Nauck T, Lohrer H. Translation, cross-cultural adaption and validation of the German version of the Foot and Ankle Ability Measure for patients with chronic ankle instability. Br J Sports Med. 2011 Aug;45(10):785-90. doi: 10.1136/bjsm.2009.067637. Epub 2009 Dec 2.

Reference Type BACKGROUND
PMID: 19955163 (View on PubMed)

Sartorio F, Vercelli S, Bravini E, Bargeri S, Moroso M, Plebani G, Ferriero G. [Foot and ankle ability measure: cross-cultural translation and validation of the Italian version of the ADL module (FAAM-I/ADL)]. Med Lav. 2014 Jul 15;105(5):357-65. Italian.

Reference Type BACKGROUND
PMID: 25134631 (View on PubMed)

Mazaheri M, Salavati M, Negahban H, Sohani SM, Taghizadeh F, Feizi A, Karimi A, Parnianpour M. Reliability and validity of the Persian version of Foot and Ankle Ability Measure (FAAM) to measure functional limitations in patients with foot and ankle disorders. Osteoarthritis Cartilage. 2010 Jun;18(6):755-9. doi: 10.1016/j.joca.2010.03.006. Epub 2010 Mar 23.

Reference Type BACKGROUND
PMID: 20338253 (View on PubMed)

Uematsu D, Suzuki H, Sasaki S, Nagano Y, Shinozuka N, Sunagawa N, Fukubayashi T. Evidence of validity for the Japanese version of the foot and ankle ability measure. J Athl Train. 2015 Jan;50(1):65-70. doi: 10.4085/1062-6050-49.3.42. Epub 2014 Oct 13.

Reference Type BACKGROUND
PMID: 25310247 (View on PubMed)

Angthong C. Validity and reliability of Thai version of the Foot and Ankle Outcome Score in patients with arthritis of the foot and ankle. Foot Ankle Surg. 2016 Dec;22(4):224-228. doi: 10.1016/j.fas.2015.09.006. Epub 2015 Oct 13.

Reference Type BACKGROUND
PMID: 27810018 (View on PubMed)

Gonzalez-Sanchez M, Li GZ, Ruiz Munoz M, Cuesta-Vargas AI. Foot and ankle ability measure to measure functional limitations in patients with foot and ankle disorders: a Chinese cross-cultural adaptation and validation. Disabil Rehabil. 2017 Oct;39(21):2182-2189. doi: 10.1080/09638288.2016.1219772. Epub 2016 Sep 6.

Reference Type BACKGROUND
PMID: 27597231 (View on PubMed)

Celik D, Malkoc M, Martin R. Evidence for reliability, validity and responsiveness of Turkish Foot and Ankle Ability Measure (FAAM). Rheumatol Int. 2016 Oct;36(10):1469-76. doi: 10.1007/s00296-016-3485-4. Epub 2016 May 2.

Reference Type BACKGROUND
PMID: 27136921 (View on PubMed)

Borloz S, Crevoisier X, Deriaz O, Ballabeni P, Martin RL, Luthi F. Evidence for validity and reliability of a French version of the FAAM. BMC Musculoskelet Disord. 2011 Feb 8;12:40. doi: 10.1186/1471-2474-12-40.

Reference Type BACKGROUND
PMID: 21303520 (View on PubMed)

Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.

Reference Type BACKGROUND
PMID: 16309613 (View on PubMed)

Brown, T.A., Confirmatory factor analysis for applied research. 2015: Guilford publications.

Reference Type BACKGROUND

Andresen EM. Criteria for assessing the tools of disability outcomes research. Arch Phys Med Rehabil. 2000 Dec;81(12 Suppl 2):S15-20. doi: 10.1053/apmr.2000.20619.

Reference Type BACKGROUND
PMID: 11128900 (View on PubMed)

Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

Reference Type BACKGROUND
PMID: 2002127 (View on PubMed)

Maskey, R., et al., Use of exploratory factor analysis in maritime research. 2018. 34(2): p. 91- 111.

Reference Type BACKGROUND

Arunakul M, Arunakul P, Suesiritumrong C, Angthong C, Chernchujit B. Validity and Reliability of Thai Version of the Foot and Ankle Ability Measure (FAAM) Subjective Form. J Med Assoc Thai. 2015 Jun;98(6):561-7.

Reference Type BACKGROUND
PMID: 26219160 (View on PubMed)

Kline, R.B., 2015. Principles and practice of structural equation modeling: Guilford publications. Principles and practice of structural equation modeling: Guilford publications.

Reference Type BACKGROUND

Other Identifiers

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

IRB- UOL-FAHS/810-XXII/2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.