The primary objective is to compare the IntelLeg Knee on the execution of a subset of daily activities for individuals with a transfemoral amputation to auto-adaptive or mechanical (non-powered) prosthetic knee via musculoskeletal simulation. The…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Transfemorale amputatie (als gevolg van bijvoorbeeld trauma of diabetes)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters for the first part of the study are joint kinetics
and joint load and induced acceleration analyses, obtained through
musculoskeletal simulations. Left-to-right symmetry mean and peak values and
the timing of peak values will be evaluated between the prostheses, as well as
comparing them to literature. For the second part of the study the study
parameters are the same, now comparing the analyses only for level-walking for
the IntelLeg Knee before and after subject specific parameter adjustment and
gait instructions, using the daily prosthesis as reference.
Secondary outcome
Not applicable.
Background summary
As of now, the commercial market remains mostly exclusive to passive,
auto-adapative knee prostheses (e.g. Össur Rheo Knee, Otto Bock C-Leg/ Genium,
Freedom Innovation Plie, Blatchford Orion). Only one powered, motorized knee
prosthesis is available, the Össur Power Knee. Unfortunately, the first
generation of the Power Knee (as introduced in 2006) was not well received, as
it was expensive, bulky, heavy, noisy and had a short battery life of around 6
hours (Edelstein & Moroz, 2011). As a matter of fact, there is no agreement in
scientific literature on the benefits of the Power Knee with respect to passive
knee prostheses (Hafner & Askew, 2015; Simon et al., 2016; Wolf et al., 2012).
The company Reboocon Bionics B.V. has developed a new lightweight powered knee
prosthesis, referred to as the IntelLeg Knee. This knee prosthesis is
lightweight (2.4 kg including battery) and is actuated using a spindle
mechanism. It is expected that transfemoral amputees may benefit from the
IntelLeg Knee compared to their daily use prosthesis. The IntelLeg Knee
provides full control of the knee joint and is able to inject energy into the
system, allowing for active promotion of stance knee flexion during gait
(Creylman et al., 2016). The injection of power can possibly decrease the load
on, and work done by, the sound leg (Ingraham et al., 2016; Pasquina et al.,
2017) during gait as well as reduce the level of asymmetry in muscle activation
in the low back spinae regions and lower extremity muscles (Jayaraman et al.,
2018). On top of that, the IntelLeg might be beneficial in particular when
performing more energy-demanding tasks, such as getting up from a chair (Wolf
et al., 2013), crossing over obstacles (Mendez et al., 2020) and also might be
able to make a running gait possible (Shultz et al., 2015).
The proposed study extends earlier clinical evaluation (NL68471.044.18 -
Evaluation of Reboocon IntelLeg Knee (ILK).) The previous study focussed on
testing different movement controllers and compare the IntelLeg knee to the
daily use prosthesis of subjects. The main study parameters were
temporal-spatial and kinetic parameters as well as subjective evaluations.
This newly proposed study extends the evaluation in two ways. First,
musculoskeletal simulations will be done for the walking gait which gives the
possibilities to investigate joint kinetics and make joint load and induced
acceleration analyses. This can give information on the loading of both legs,
joint power generation and joint contact forces. It has been found that right
now transfemoral amputees load their legs asymmetrical (Vrieling et al., 2008),
which can lead to joint degeneration (Burke et al., 1978; Hurwitz et al., 2001)
and lower back pain (Jayaraman et al., 2018; Shojaei et al., 2016). On top of
that, induced acceleration analyses will be done to identify the effect of the
muscles and prosthesis towards the center of mass trajectories. This can give
the ability to find out if the prosthesis takes over the muscle function of the
missing muscles (vasti, soleus and gastrocnemius) as well as to find gait
compensatory mechanism.
Next to analysing regular walking gait, three other activities will be
evaluated using the same techniques: sit-to-stand, stepping over an object and
running. Stepping over an object and running were not evaluated in the previous
study. The running gait will only be evaluated with subjects capable of already
achieving a running gait with their current prosthesis. Next to using the
results to give a better insight in the IntelLeg Knee performance, there is
either very little or no literature available on the proposed analyses with
passive or powered prostheses, making this study contribute to the current
scientific research.
The second part of the study evaluates the possibilities of improving gait with
subject specific instructions as well as tweaking prosthesis parameters. This
will be done based on the results gained through musculoskeletal simulations.
The main goal is to make the subject use the full potential of the powered
prosthesis which requires different gait strategies than with a non-powered
prosthesis.
Study objective
The primary objective is to compare the IntelLeg Knee on the execution of a
subset of daily activities for individuals with a transfemoral amputation to
auto-adaptive or mechanical (non-powered) prosthetic knee via musculoskeletal
simulation. The device will be evaluated using joint kinetics, joint load
analyses and induced acceleration analysis analyses. The secondary objectives
are exploring the possibilities of using results from musculoskeletal
simulation to improve gait instructions and prosthesis parameters and make a
useability analysis and design validation of the IntelLeg Knee.
Study design
The study consists of two main parts. The first part, focused on a subset of
daily activities, is designed as an intervention study. The IntelLeg Knee is
compared to the daily use prothesis of the subjects with unilateral
transfemoral amputee. The second part of the study is designed as an A-B1-B2
study, effectively comparing results of the IntelLeg Knee at the beginning (B1)
and end of the session (B2), using the daily use prosthesis as reference (A).
Intervention
Part I of the study is designed as an intervention study with A the baseline
measurement (subject*s own prosthesis) and B the intervention (IntelLeg Knee).
Part II of the study is designed as an A-B1-B2 study. In here B1 is the
baseline measurement (IntelLeg Knee, beginning of session), B2 the intervention
(IntelLeg Knee, end of the session) and A is used as reference (subject*s own
prosthesis).
Study burden and risks
All experiments are non-invasive, in which participants are asked to perform
activities of daily living. Both studies combined last 3 weeks with 3
measurement sessions of 2 hours. In the case that new subjects are recruited,
the study last one week longer with an extra training session of 3 hours. Thus,
in 3-4 weeks the participants spend around 6-9 hours of active participation.
All participants can take rest during the experiments and participate at their
own pace.
The risks for the subjects participating in this study are small. All
experiments are performed wearing a fall prevention system which will prevent
any injury and prevent the subjects from falling. This creates a safe and
controlled environment for all activities investigated in this study.
The study does not lead to any direct benefits for the subjects but may lead to
improved control or insights to the added benefit of the IntelLeg Knee as well
as contribute to the current scientific research.
Rotterdamseweg 386-B1
Delft 2629 HG
NL
Rotterdamseweg 386-B1
Delft 2629 HG
NL
Listed location countries
Age
Inclusion criteria
(Preferably, the subjects have already participated in a previous study and are
familiar with the IntelLeg Knee.)
- Aged between 18 and 65.
- Weight below 125 kg.
- Body length between 1.51 and 1.95 m.
- Unilateral transfemoral amputation or k nee disarticulation.
- Functional level from K2 to K4
o Level 2: The patient has the a bility or potential for ambulation with the
ability to traverse low-level environmental barriers such as curbs, stairs, or
uneven surfaces. Typical of the limited community ambulator.
o Level 3: The patient has the ability or potential for ambulation with
variable cadence. Typical of the community ambulatory who has the ability to
traverse most environmental barriers and may have vocational, therapeutic, or
exercise activity that demands prosthetic utilization beyond simple locomotion.
o Level 4: The patient has the ability or potential for prosthetic ambulation
that exceeds basic ambulation skills, exhibiting high impact, stress, or energy
levels. Typical of the prosthetic demands of the child, active adult, or
athlete.
- Able to perform low to moderate vigorous physical activity for a duration of
2 hours including breaks.
- At least one year after amputation.
Exclusion criteria
- Not willing to consent to partic ipate in the study.
- Other musculoskeletal problems influencing wal king ability.
- Stump problems/bad socket fitting
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 | NL76303.091.22 |