To compare the functional mobility of transfemoral amputation or knee exarticulation patients when using the ReMotion Knee and their current prosthetic knee. An additional aim is to examine the influence of the patient*s mobility level on the…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in time (s) it takes the participant
to finish the L-test between the two conditions. The test includes standing up
and sitting down, twenty meters of straight walking and four turns, of which
one is over the side of the prosthetic leg.
Secondary outcome
Secondary study parameters are gait quality, balance, precision stepping,
performance of advanced walking tasks and patient experience. Gait quality is
defined by walking speed, step length and %single limb support time. This will
be measured using Intertial Measurement Units (IMUs) on the trunck and the
feet. Balance is measured using the Berg Balance Score and the load
distribution during static stance. Precision stepping will be measured using
the Four Square Step Test. Advanced walking tasks are assessed using the EFAP,
which combines a transfer (TUG), regular walking and advanced walking tasks.
Finally, patient experience will be measured using an Numeric Rating Scale
(NRS) to score the comfort, performance, fatigue and trust in balance using
both proshtetic knees. After all the measurements, the participants are asked
which prosthetic knee has their preference on each of these items.
Background summary
Ambulatory mobility and function are important aspects in the quality of life
of people with lower limb amputations and prostheses. Regaining mobility is
often challenging, especially for patients with transfemoral, or above-knee
amputations. In clinical practice, the patient*s mobility level the intended
use of their prosthesis determine which prosthesis is the best fit for them. In
the past decades, new types of knee prosthetics have entered the market. The
standard care in Europe and the US at this moment is the mechanical, or
non-microprocessor controlled, knee (NMPK). While the production costs of these
NMPK*s are lower than those of the MPK*s (microprocessor controlled knee),
consumer prices still reach up to $5000. Recently, the ReMotion Knee ($80) was
developed as a new and affordable alternative to the currently available
mechanical knees. The ReMotion Knee is mostly used in low-income, but has now
received the CE mark. However, research about functional mobility and user
experiences with the knee is very limited, especially in our western society.
Study objective
To compare the functional mobility of transfemoral amputation or knee
exarticulation patients when using the ReMotion Knee and their current
prosthetic knee. An additional aim is to examine the influence of the patient*s
mobility level on the difference in functional mobility between the two
prosthetic knees.
Study design
Randomized crossover trial.
Intervention
Participants perform a set of functional measurements twice: once using the
ReMotion Knee and once using their own prosthetic knee.
Study burden and risks
Participants visit the research site once for 3-4 hours. During their visit
they perform a set of functional measurements twice, once with their current
prosthetic knee and once with the ReMotion Knee. The knees will be exchanged by
an experienced prosthetist. To familiarize with the ReMotion Knee, a training
session is held under supervision of a physical therapist. If the participant
has a high risk of falling, the measurements will be held in the Zero-G (zero
gravity support), which has a passive fall prevention mechanism.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67281.091.18 |