The goal of the research is to apply balance perturbations during standing and walking, and capture the resulting stepping responses. These data will be used to develop and verify predictive models of foot placement. Such models might eventually be…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters under study are stepping location (length, width) and swing
time (time between toe-off and heel strike).
Secondary outcome
Secondary endpoints are the distance between center of mass and center of
pressure, ground reaction forces of the stance leg(s), joint angles and joint
torques, body momentum, body sway in the frontal plane, and muscle (reflexive)
activity as resulting from an externally applied perturbation and during the
balance recovery thereof, as well as their relation to the primary study
parameters.
The study parameters will be incorporated in a mathematical explanatory model
that describes the relations between the main and secondary study parameters,
both for healthy subjects and stroke survivors. This way, human-like stepping
behavior might be predicted given the observed related quantities. Furthermore,
data collected in experiments done with and without the balance device, will be
compared in order to evaluate the contribution of the inertial flywheel
actuator in helping subject to keep balance.
Background summary
In daily life the upright human body is continuously challenged by external
disturbances, such as gravitational forces and forces originating from
interactions with the environment. These disturbances can lead to a loss of
balance, which must be acted upon accordingly to prevent a fall. Following a
disturbance, proper foot placement is crucial for maintaining balance during
both standing and walking. However it is unclear why humans place their foot at
a certain location at a certain time following an unexpected balance
disturbance. A model based prediction of a suitable foot placement location to
maintain balance and prevent falls can have great value in both clinical and
robotics fields of research. Investigating foot placement in stroke patients
can lead to a better understanding how stroke related complications affect foot
placement, and how these might be compensated using supportive devices such as
exoskeletons or balance keeping devices. The latter are wearable and portable
robotic devices developed with the aim of detecting the subject*s loss of
balance and of providing corrective actions to avoid or delay the risk of
falling. An open research topic related to the development of these devices
deals with assessing their effectiveness by evaluating how human balance
performance changes by using supportive devices.
Study objective
The goal of the research is to apply balance perturbations during standing and
walking, and capture the resulting stepping responses. These data will be used
to develop and verify predictive models of foot placement. Such models might
eventually be incorporated in rehabilitation or balance assisting devices.
Another aim of this study is to assess how the balance keeping performance of
subjects changes by using a supportive device. An inertial flywheel actuator
has been designed at UT to assist subjects in keeping balance in the frontal
plane. The effectiveness of the device will be evaluated by comparing the
balance keeping performance of subjects when they wear and when they do not
wear the inertial flywheel actuator.
Study design
The study is designed as a non-invasive cross-sectional intervention study to
assess foot placement for the control of balance during standing and walking.
The effectiveness of the inertial flywheel actuator in supporting subjects to
keep balance in the frontal plane will be also evaluated. It consists of two
main experiments, one in standing and one in walking, each consisting of one or
more sessions. The test conditions within a session will be randomized. Healthy
subjects might be asked to participate in an additional session with altered
conditions that were not captured in the main session. Stroke survivors will
only participate in the main session.
Intervention
Balance will be perturbed during standing and/or walking by applying sudden
forces of various magnitudes and duration at the pelvis, and by sudden
movements of different magnitude and speed of the belts of the treadmill..
These perturbations are applied using two external devices: the pelvis
perturbator and the treadmill. The disturbances are sub-maximal. They challenge
the subject to make a corrective step, but do not have the goal to make them
fall.
Study burden and risks
All experiments are non-invasive procedures involving disturbances similar to
those that could occur in daily life. A single experiment will require
approximately 45 minutes of active participation for healthy subjects, and
approximately 12 minutes for stroke patients. This is not expected to put
extensive load on the subjects. All subjects can take rests during the
experiment and participate on their own pace. Risks leading to injury of the
subject are low, given the safety precautions. The study does not lead to any
direct benefits for the subject, but may lead to a better understanding of
stepping responses in human balance control and it may prove that the inertial
flywheel actuator improves the human balance performance. This knowledge might
be applied in both clinical and robotics fields of research.
Stroke survivors will be included to characterize balance control specifically
related to the complications occurring after stroke. Understanding in which way
these complications hamper balance control might lead to better methods of
support, e.g. during rehabilitation.
De Horst 2
Enschede 7522 LW
NL
De Horst 2
Enschede 7522 LW
NL
Listed location countries
Age
Inclusion criteria
Healthy:
Subjects of age 18-40 years;Stroke:
Between 18 and 70 years of age
Diagnosed with a hemiparesis as the result of a first ever ischemic stroke
>6 months post-stroke (chronic stage)
functional ambulation category (FAC) 4: walk independently on level surfaces
physical condition allows independent walking for at least 3 consecutive minutes
stable medical condition
sufficient cognitive abilities (MMSE><=22)
sufficient communication abilities (UCO ><= 3);Both:
Body weight<100 kg
Written informed consent
Exclusion criteria
Healthy:
current lower extremity problems or deficiencies (e.g. problems with walking)
(history of) neurological or balance related disorders;Stroke:
(history of) neurological or balance related disorders not related to stroke;Both:
using medication that can affect balance control
pregnancy
chronic joint pain
orthopedic problems
(history of) cardiac conditions that interfere with physical load
(history of) skin diseases
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 | NL50450.044.14 |
OMON | NL-OMON25102 |