ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02439463
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jussi Repo, Helsinki University Central Hospital

Brief Summary:
The present study assesses the health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis.

Condition or disease Intervention/treatment
Amputees Procedure: Below-knee amputation

Detailed 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.

Study Type : Observational [Patient Registry]
Actual Enrollment : 26 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss


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


Primary Outcome Measures :
  1. The health-related quality of life measured by HRQoL score [ Time Frame: 2-5 years ]
  2. Locomotor capabilities of traumatic below-knee amputees with prothesis [ Time Frame: 2-5 years ]

Secondary Outcome Measures :
  1. 15D health-related quality of life instrument [ Time Frame: 2-5 years ]
  2. Prothesis Evaluation Questionnaire [ Time Frame: 2-5 yeats ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Below-knee amputees who use limb prosthesis
Criteria

Inclusion Criteria:

  1. Below-knee prosthesis users with amputation due to trauma
  2. age >18

Exclusion Criteria:

1. Patients with no prosthesis


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439463


Locations
Finland
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Study Director: Erkki J Tukiainen, MD,PhD Helsinki University Central Hospital

Responsible Party: Jussi Repo, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02439463     History of Changes
Other Study ID Numbers: 364/13/03/02/2014/7
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018