MyLeg P1: The functional evaluation of a ankle prosthesis prototype for osseointegrated transfemural amputees
- Conditions
- Above-knee amputationtransfemoral amputation10023213
- Registration Number
- NL-OMON48203
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
18 year or older and able to provide informed consent.
Underwent a uni-lateral transfemoral amputation and underwent a surgery
implementing the osseointegration implant more than 2 years ago.
Able to walk independently (MFC-level K3 or higher)
Exclusion Criteria
Vascular, neurological or musculoskeletal conditions or medication affecting
balance or gait
Patients with psychiatric disorders
Weight > 100 kg
Current problems with the alignment of the prosthesis
Fitted with a new prosthesis knee-component within the last 3 months or with a
new prosthesis ankle-component within the last month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are oxygen consumption, walking distance, and the<br /><br>symmetry index for spatiotemporal, kinetic and kinematic parameters. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Functionality is captured in number of stumbles during walking and the answers<br /><br>on the user report. The participant*s experience by the answers on the user<br /><br>report. </p><br>