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NCT02439463 Clinical Trial

Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities

Amputees Clinical Trial

Official title:
Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02439463
Other study ID # 364/13/03/02/2014/7
Secondary ID
Status Completed
Phase N/A
First received May 5, 2015
Last updated February 21, 2018
Start date June 2015
Est. completion date January 2018

Study information
Verified date February 2018
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 health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis.

Description:

A cross sectional study based on a retrospective review of prosthetic using major traumatic lower limb amputees' demographic and clinical details together with HRQoL and locomotor capabilities patient-reported outcome measures.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Below-knee prosthesis users with amputation due to trauma

2. age >18

Exclusion Criteria:

1. Patients with no prosthesis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Below-knee amputation
Patients with traumatic below-knee amputation.

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

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 The health-related quality of life measured by HRQoL score 2-5 years
Primary Locomotor capabilities of traumatic below-knee amputees with prothesis 2-5 years
Secondary 15D health-related quality of life instrument 2-5 years
Secondary Prothesis Evaluation Questionnaire 2-5 yeats
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