An observational study in Foot Diseases and Ankle Disease, sponsored by Helsinki University Central Hospital. Completed at 4 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Helsinki University Central Hospital · Observational
The present study investigates the minimal important change and validity of foot and ankle measures.
Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided.
The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments.
47 studies on the registry are indexed under Foot Diseases; 9 are open to participants now.
Browse Foot Diseases studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study recruits adult patients who are undergoing foot or ankle surgery for various reasons.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Surgery for foot or ankle
Also known as: correction forefoot, correction midfoot, correction hindfoot, correction ankle, combined correction, procedures for osteoarthritis foot or ankle, procedures for instability ankle, correction flatfoot, correction cavus foot, correction equinus foot, procedures for Diabetic ulcer, procedures for Charcot, procedures for tendinopathy Achilles, procedures for tendinopathy other, osteosynthesis, Other foot or ankle surgery
Minimal important difference
Change from baseline scores at 6 months
Time frame: Baseline, 6 months
Reliability
Change from 6 months scores at 6.5 months
Time frame: 6 months, 6.5 months
General health question
Change from baseline scores at 6 months
Time frame: Baseline, 6 months
General health question
Change from baseline scores at 6 months
Time frame: 6 months, 6.5 months
Global assessment scale
Change from baseline scores at 6 months
Time frame: 6 months
Validity
Baseline scores
Time frame: Baseline
Validity
6 months scores
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Mar 2019, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Helsinki University Central Hospital →