NCT02330198

Brief Summary

The purpose of this study is to validate the Foot and Ankle Ability Measure in Finnish.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

December 30, 2014

Last Update Submit

November 4, 2015

Conditions

Ankle Sprain

Keywords

self-reported outcome instrument

Outcome Measures

Primary Outcomes (1)

  • Modified American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot score

    3 months

Secondary Outcomes (1)

  • 15 D instrument questionnaires

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 patients who will receive operative treatment at the Turku University Hospital Foot and ankle unit, At the outpatient clinics of Turku University Hospital and Physiotherapy Consults Helsinki 40 foot and ankle patients who will get physiotherapy

You may qualify if:

  • Foot and ankle patients who will receive either conservative or operative treatment will be included. Mother language of the patients is Finnish.

You may not qualify if:

  • Age under 18 or denial of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital Orthopedics department

Turku, Turku, 20810, Finland

Location

Related Publications (8)

  • 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.

    PMID: 11124735BACKGROUND

  • Beaton DE, Schemitsch E. Measures of health-related quality of life and physical function. Clin Orthop Relat Res. 2003 Aug;(413):90-105. doi: 10.1097/01.blo.0000079772.06654.c8.

    PMID: 12897600BACKGROUND

  • Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.

    PMID: 8263569BACKGROUND

  • 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.

    PMID: 21303520RESULT

  • 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.

    PMID: 18345343RESULT

  • 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.

    PMID: 20338253RESULT

  • 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.

    PMID: 16309613RESULT

  • 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.

    PMID: 19955163RESULT

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Jaana Koski, PhT

    physiotherapist

    PRINCIPAL INVESTIGATOR

  • Jukka Kangas, PhT

    physiotherapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 1, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

FI(1)