Ankle Sprain Clinical Trial
Official title:
Evidence for Validity and Reliability of the Finnish Version of the Foot and Ankle Ability Measure
The purpose of this study is to validate the Foot and Ankle Ability Measure in Finnish.
The aim of this study is to translate and adapt The Foot and Ankle Ability Measure tool
(FAAM) in Finnish language and to evaluate the validity and reliability of the Finnish
version of the Foot and ankle ability measure tool (FAAM-Fi).
This study is prospective. It is done by interviewing the patients to gather self-reported
information of about their ability to perform different activities of daily living and
sports. The study has no consequence to the patients, nor to the treatment aimed to solve
the problem. This study includes cross-cultural adaptation of the FAAM to Finnish language
and validation of the Finnish version of the FAAM.
The forward translation will be done with the method of used by the American Association of
Orthopedic Surgeons (AAOS) Outcomes Committee. Two native Finnish-speakers and fluent in
English translators, T1 and T2, translate the original version of the FAAM to Finnish
language. T1 is aware of the items being examined in in the questionnaire being translated,
but not a healthcare professional. T2 is so called naïve translator. A synthesis of T1 and
T2 versions, T-12, is conducted under the supervision of a medical linguistic methodologist.
The T-12 version is translated back to English by two native, English as their mother tongue
speaking translators BT1 and BT2, neither aware nor informed of the items explored nor with
medical background.
An expert committee (the medical linguistic professional, the investigator as an orthopedic
specialist and the translators) consolidate all the versions and consider the pre-final
version of the questionnaire. The expert committee will be in close contact with developers.
The pre-final version is pre-tested with 40 persons with foot and ankle disorders. They will
complete the questionnaire and will be interviewed about the meaning of the questions and
the response in order to ensure that the adapted version is retaining its equivalence in an
applied situation. Possible missing responses are looked for. The last step is submitting
the final version, the FAAM-Fi and all the written reports to the committee keeping track of
the translated version and the developers of the final version.
Process for validating the FAAM-Fi includes testing it for reliability, validity and its
responsiveness. 80 patients receiving either conservative or operative treatment for foot
and ankle disorders are recruited from Turku University Hospital and Physiotherapy Consults,
Helsinki. 40 patients are treated operatively and 40 conservatively.
40 patients who will receive operative treatment at the Turku University Hospital Foot and
ankle unit are asked to answer the questions of the Finnish version of the FAAM, the
modified AOFAS foot and ankle scale and the 15-D instrument by a paper or by an electrical
version. At the outpatient clinics of Turku University Hospital and Physiotherapy Consults
Helsinki 40 foot and ankle patients who will get physiotherapy fill in these forms. 20 of
these patients are recruited from Turku University Hospital and 20 from Physiotherapy
Consults Helsinki. Those patients who will be treated operatively fill in the questionnaires
at the preoperative interview and in the morning of the surgery. The diagnoses are written
down as well as the procedures of the operated patients. The patients will re-fill the
questionnaires again at the post-operative control at 3 months.
As this is an interview study there will be no randomizing or blinding.
The study will start in October 2014 and the required information should be gathered in six
months. Statistical analysis and first results should be ready in June 2015.
Source population is foot and ankle patients at the outpatient clinic of Artro process of
the Turku University Hospital and Physiotherapy Consults, Helsinki.
Number of subjects will be 80.
Test-retest repeatability is evaluated statistically by the agreement of repeated tests.
Cronbach´s coefficient alpha is calculated to assess internal consistency. Content validity
is assessed by floor and ceiling effects. Criterion validity is tested by correlation to the
modified AOFAS foot and ankle scale and 15-D. Construct validity is assessed by creating
five hypotheses for convergent validity and one for discriminate. Responsiveness is assessed
by calculating the effect size and the standardized effect mean.
All data for this study is collected from patient files and hospitals´ electronic patient
registry (Artux, BCB Medical Finland). All data is stored and secured in a specific
electronic study subject register. Paper data is stored in a locker in the principal
investigators office room at the Turku University Hospital. Patient data is accessible to
investigators only.
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Observational Model: Case-Only, Time Perspective: Prospective
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