The primary objective is to evaluate the added value of the IntelLeg Knee on the execution of activities of daily living for individuals with a transfemoral amputation when compared to the use of an auto-adaptive or mechanical (non-powered)…
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
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/ endpoints of part I are the comparison of kinematics
to normative data (Winter, 1984), the Borg-Scale (rate of perceived effort) for
different control algorithms and different activities and are all sensory data
from the IntelLeg Knee. These parameters will be used to determine the optimal
controllers for the IntelLeg Knee.
The main study parameter/ endpoints of part II are comparisons between baseline
and intervention measurements, such as self-selected preferred walking speed,
fastest walking speed, metabolic energy consumption during walking, uphill
walking and stair negotiation, Borg-Scale (rate of perceived effort), relevant
subscores of the Prosthesis Evaluation Questionnaire, the Hill Assessment
Index, the Stair Assessment Index, the time to complete the L-test, TUG-test
and time to complete the Four Square Step Test.
Secondary outcome
The secondary study parameters/ endpoints of part I are videos recorded during
the measurements.
The secondary study parameters/ endpoints of part II are all sensory data from
the IntelLeg Knee, classification accuracy of intent recognition algorithms
using the IntelLeg Knee, kinematics (including left-to-right symmetry) and
muscle activity (to assess significant changes between subject*s daily use
prosthetic knee and the IntelLeg Knee)
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 and 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. Although some research find that the active knee prosthesis
improves symmetry and reduces load of the intact leg for some tasks (Wolf,
Everding et al. 2012, Simon, Fey et al. 2016), Hafner and Askew (Hafner and
Askew 2015) report that the Össur Power Knee (second generation) *significantly
limited users laboratory based mobility and overall daily activity* and that
*active knee control, as it is implemented in the Power Knee II, may not be
ideal for middle-age or older persons with TFA*.
The start-up company Reboocon Bionics B.V. has developed a new lightweight
powered knee prosthesis, referred to as the IntelLeg Knee. This knee prosthesis
is lightweight (2.5 kg including battery) and is actuated using a spindle
mechanism. It is expected that transfemoral amputees may benefit from the
IntelLeg Knee compared to the their passive, auto-adaptive or mechanical 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, Knippels et al. 2016) and performing
more energy-demanding tasks with less effort, such as getting up from a chair
(Wolf, Everding et al. 2013), step-over-step stair ascent (Young and Hargrove
2016, Ledoux and Goldfarb 2017) or upslope walking (Sup, Varol et al. 2011).
As becomes clear from the study of Hafner and Askew (Hafner and Askew 2015),
the type of active control used is of key importance for the performance of the
IntelLeg Knee. Therefore, this study is focussed on developing and evaluating
different controllers for a relevant subset of activities, including algorithms
which are concerned with identifying the intent of the user, to be evaluated
using the IntelLeg Knee.
Study objective
The primary objective is to evaluate the added value of the IntelLeg Knee on
the execution of activities of daily living for individuals with a transfemoral
amputation when compared to the use of an auto-adaptive or mechanical
(non-powered) prosthetic knee. The second objectives are to develop control
algorithms to restore natural movement of the knee for different activities of
daily living and to develop unambiguous, robust and natural transitioning
between different activity modes.
Study design
The study consists of two main parts. The first part, concerned with developing
control algorithms for different activities and transitioning between activity
modes, is designed as an iterative usability study. The second part, concerned
with comparing the IntelLeg Knee to other passive prostheses in individuals
with a unilateral transfemoral amputee, is designed as a comparative study. In
this study, measurements with the participants' daily use prosthesis and
IntelLeg Knee will be done within the same session, allowing for direct
comparison between both knees.
Intervention
Not applicable
Study burden and risks
All experiments are non-invasive, in which participants are asked to perform
activities of daily living. Study one entails 10 weekly usability sessions,
each requiring about 2 hours of active participation (20 hours in total). Part
II of the study), lasts 6 weeks with 2 measurements sessions (3 hours) and 4
training session (2 hours). A separate session to fit the IntelLeg Knee to the
subject will require about 1 hours. Thus, in these 6 weeks, participants spend
about 15 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 (the ZeroG system,
CE-marked), 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.
Rotterdamseweg 386-B1
Delft 2629 HG
NL
Rotterdamseweg 386-B1
Delft 2629 HG
NL
Listed location countries
Age
Inclusion criteria
Individuals without an amputation
- Aged between 18 and 65.
- Body length between 1.20 and 1.95 m.
- Weight below 125 kg.
- Able to perform low to moderate vigorous physical activity for a duration of
3 hours including breaks., Individuals with an amputation
- Aged between 18 and 65.
- Weight below 125 kg.
- Body length between 1.20 and 1.95 m.
- Unilateral transfemoral amputation or knee disarticulation.
- Auto-adaptive or mechanical prosthesis user
- Functional level from K2 to K4
o Level 2: The patient has the ability 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
3 hours including breaks.
- Has finished rehabilitation and uses own prosthesis at home for more than 3
months.
- Willing to commit to a series of 4 training sessions to get adjusted to the
IntelLeg Knee.
Exclusion criteria
Individuals without an amputation:
- Not willing to consent to participate in the study.
- Musculoskeletal problems influencing walking ability., Individuals with an
amputation:
- Not willing to consent to participate in the study.
- Other musculoskeletal problems influencing walking ability.
- Stump problems/bad socket fitting, Only for study I (for both individuals
with and individuals without amputation):
- For the second and third individual with amputation, subject*s weight differs
more than 15 kg of already included subject(s) or subject*s length differs
more than 15 cm of already included subject(s).
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL68471.044.18 |
| OMON | NL-OMON25551 |