NCT02436148

Brief Summary

The present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

May 2, 2015

Last Update Submit

August 14, 2017

Conditions

Amputation Stump

Keywords

PEQ validation study, Finland

Outcome Measures

Primary Outcomes (1)

  • Assessing the reliability and validity of the PEQ questionnaire

    1-10 years

Secondary Outcomes (4)

  • Prothesis Evaluation Questionnaire

    1-10 years

  • Houghton prothesis user score

    1-10 years

  • Locomotor Capabilities Index - 5

    1-10 years

  • Prothesis Evaluation Questionnaire Mobility Section - 5

    1-10 years

Interventions

Prosthetic for major lower limb amputationOTHER

Prosthetic for major lower limb amputee

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with major lower extremity amputation who has been prothetized.

You may qualify if:

  • Major lower extremity amputation Prothetization

You may not qualify if:

  • Other amputation besides major lower extremity
  • No prothesis in use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Central Finland Central Hospital

Jyväskylä, Finland

Location

Study Officials

  • Erkki J Tukiainen, MD,PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 2, 2015

First Posted

May 6, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

FI(2)