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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02436148
Other study ID # 364/13/03/02/2014/1
Secondary ID
Status Completed
Phase N/A
First received May 2, 2015
Last updated August 14, 2017
Start date March 2015
Est. completion date December 2015

Study information

Verified date August 2017
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- Major lower extremity amputation Prothetization

Exclusion Criteria:

- Other amputation besides major lower extremity

- No prothesis in use

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Prosthetic for major lower limb amputation
Prosthetic for major lower limb amputee

Locations

Country Name City State
Finland Helsinki University Central Hospital Helsinki Uusimaa
Finland Central Finland Central Hospital Jyväskylä

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessing the reliability and validity of the PEQ questionnaire 1-10 years
Secondary Prothesis Evaluation Questionnaire 1-10 years
Secondary Houghton prothesis user score 1-10 years
Secondary Locomotor Capabilities Index - 5 1-10 years
Secondary Prothesis Evaluation Questionnaire Mobility Section - 5 1-10 years
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