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MyLeg P1: The functional evaluation of a ankle prosthesis prototype for osseointegrated transfemural amputees

MyLeg P1: The functional evaluation of a ankle prosthesis prototype for osseointegrated transfemural amputees - MyLeg P1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48203
Enrollment
4
Registered
2020-01-16
Start date
2020-02-15
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Above-knee amputation transfemoral amputation

Interventions

An introduction and practice with the prosthesis prototype inside the Radboudumc under supervision of a physiotherapist, researcher, orthopaedic technician, and the manufacturer.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main study parameters are oxygen consumption, walking distance, and the symmetry index for spatiotemporal, kinetic and kinematic parameters.

Secondary

MeasureTime frame
Functionality is captured in number of stumbles during walking and the answers on the user report. The participant*s experience by the answers on the user report.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)