Reliability and Validity of the Finnish Version of the Pr... | NCT02436148

Studies
Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire

NCT02436148

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Aug 16, 2017Actual

Enrollment

140Actual

Phase

Not provided

Conditions

Amputation Stump

Interventions

Prosthetic for major lower limb amputation

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

May 2, 2015

First Submission Date that Met QC Criteria

May 5, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2017

Last Update Posted Date

Aug 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jussi Repo, Researcher, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

> 100 lower extremity prosthetic users with major lower extremity amputation are recruited for the present study. The aim is to assess the reliability and validity of the Finnish version of the Prothesis Evaluation Questionnaire (PEQ). The participants fill in a pre information form, the PEQ, the 15D health-related quality of life questionnaire, Houghton prothesis questionnaire, Locomotor Capabilities Index - 5, Prothesis Evaluation Questionnaire Mobility Section - 5. The psychometric abilities of the PEQ instrument are analyzed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prosthetic for major lower limb amputation	Other	Prosthetic for major lower limb amputee

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessing the reliability and validity of the PEQ questionnaire		1-10 years

Secondary Outcomes

Measure	Description	Time Frame
Prothesis Evaluation Questionnaire		1-10 years
Houghton prothesis user score		1-10 years
Locomotor Capabilities Index - 5

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major lower extremity amputation Prothetization

Exclusion Criteria:

Other amputation besides major lower extremity
No prothesis in use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with major lower extremity amputation who has been prothetized.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkki J Tukiainen, MD,PhD	Helsinki University Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki	Uusimaa	00029	Finland
Central Finland Central Hospital