NCT02536651

Brief Summary

There are no validated patient-reported outcome measures to assess lower extremity function in Finnish language. The present study aimed to 1)translate and culturally validate the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale, and 2) study the psychometric properties of these two questionnaires

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

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

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 23, 2015

Last Update Submit

August 14, 2017

Conditions

Foot DiseasesAnkle Disease

Keywords

validation studies, patient-reported outcome measures

Outcome Measures

Primary Outcomes (2)

  • The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale

    Assessment of the validity

    2 months to 10 years

  • The reliability of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale

    Assessment of the test-retest reliability

    2 months to 10 years

Secondary Outcomes (6)

  • Visual Analogue Scale Foot and Ankle questionnaire

    2 months to 10 years

  • Lower Extremity Functional Scale questionnaire

    2 months to 10 years

  • Kasari FIT (Function Intensity Time) index

    2 months to 10 years

  • The 15-Dimensions health-related quality of life instrument

    2 months to 10 years

  • Visual Analogue Scales

    2 months to 10 years

  • +1 more secondary outcomes

Interventions

Ankle surgeryPROCEDURE

Plastic or orthopedic surgery of the ankle

Eligibility Criteria

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

Patients who have undergone surgery due to foot and ankle pathology

You may qualify if:

  • Pathology of the foot and ankle and
  • Surgery due to foot and ankle problems

You may not qualify if:

  • Other than foot and ankle surgery
  • age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Foot Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Erkki J Tukiainen, MD, PhD

    Helsinki University Hospital and University of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 23, 2015

First Posted

September 1, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 16, 2017

Record last verified: 2017-08