Functional mobility in patients with a unilateral transfemoral amputation: a comparison between the ReMotion Knee and polycentric mechanical knees currently used in healthcare.

Completed

Conditions: above-knee amputation
transfemoral amputatation
10005944

Registration Number: NL-OMON47968

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age >18
- Unilateral transfemoral amputation or knee exarticulation
- Activity level K2 or K3
- Time after amputation >1 year
- ReMotion Knee can be connected to the participant*s own socket
- Originally using a polycentric non-microprocessor controlled prosthetic knee
- Written informed consent

Exclusion Criteria

- Complaints of pain of the residual stump.
- Severe contractures affecting the hip range of motion
- Other impairments that cause an increase in pain or a decrease in walking ability when standing and/or walking for thirty minutes
- Weight >80 kg (weight limit of the ReMotion Knee is 80 kg)
- Osseointegrated prosthesis (no socket)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in time (s) it takes the participant<br /><br>to finish the L-test between the two conditions. The test includes standing up<br /><br>and sitting down, twenty meters of straight walking and four turns, of which<br /><br>one is over the side of the prosthetic leg.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are gait quality, balance, precision stepping,<br /><br>performance of advanced walking tasks and patient experience. Gait quality is<br /><br>defined by walking speed, step length and %single limb support time. This will<br /><br>be measured using Intertial Measurement Units (IMUs) on the trunck and the<br /><br>feet. Balance is measured using the Berg Balance Score and the load<br /><br>distribution during static stance. Precision stepping will be measured using<br /><br>the Four Square Step Test. Advanced walking tasks are assessed using the EFAP,<br /><br>which combines a transfer (TUG), regular walking and advanced walking tasks.<br /><br>Finally, patient experience will be measured using an Numeric Rating Scale<br /><br>(NRS) to score the comfort, performance, fatigue and trust in balance using<br /><br>both proshtetic knees. After all the measurements, the participants are asked<br /><br>which prosthetic knee has their preference on each of these items.</p><br>