Translation and Reliability of FAAM-U

Ankle Injuries Clinical Trial

Official title:

Translation, Cross-Cultural Adaptation and Reliability of Urdu Version of The Foot and Ankle Ability Measures (FAAM-U)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05997797
• Other study ID #: IRB- UOL-FAHS/810-XXII/2021
• Status: Completed
• Start date: July 2, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: August 2023
• Source: University of Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 15, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Foot Injuries
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Pakistan	The University of Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (31)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA 1996 Apr 24;275(16):1232. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 Hours