The objective of this study is:To determine whether the use of vibrating insoles during walking will improve the balance of older people.
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verminderde tactiele feedback bij ouderen
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The following parameters will be used in order to determine the effect of the
vibrating insoles on the balance:
- The step width during normal walking.
- The step width during recovery after a balance perturbation.
Secondary outcome
The following secondary parameters will be used in order to determine the
effect of the vibrating insoles on the balance:
- The variability of the step width during normal walking.
- The variability of the step width during recovery after a balance
perturbation.
Background summary
Elderly often show a declined sensory feedback and consequently experience a
considerable decrease in maintaining their balance, resulting in an increasing
fall risk which may have serious consequences. Different applications, such as
orthopaedic footwear or shoe modifications, can improve the sensory feedback.
The sensory systems which can be influcenced by such applications are the
proprioceptive and tactile system.
With increasing age the tactile feedback diminishes, which means there will be
less reaction to changes of the pressure distribution under the feet, leading
to decreasing balance capacity. A way to increase the tactile feedback of
pressure changes under the feet is the application of a vibrating signal under
the feet and with that there will be a better response to pressure changes.
The vibrating insoles will apply a noise under the feet. By adding subthreshold
electrical or mechanical noise (vibration with a randomly varying frequency) to
a subthreshold sensory input, the sensory threshold may be crossed. In this
way, a signal that is not detected during normal circumstances can be detected.
The mechanism by which detection is improved by noise is called stochastic
resonance.
The subthreshold noise signal can enhance the tactile sensation of changes in
pressure under the foot, resulting in more sensitive detection of these
pressure changes.
Study objective
The objective of this study is:
To determine whether the use of vibrating insoles during walking will improve
the balance of older people.
Study design
The researcher will administer, at random, vibrations alternated with no
vibrations. In a single-blind case-control study the "no vibration"-periods and
the young subjects will serve as the control. Since the researcher does not
have any influence on the parameters and the data is not subjectively
amendable, the researcher is aware of the vibration sequence. While the
individual subjects will not be aware of the sequence of vibration admission.
The vibrations will be administered below the sensory threshold of the subjects
and during two different conditions; walking and balance disturbance while
walking.
Study burden and risks
Each subject will undergo one walking experiment which will require one visit
to the hospital from the subjects. The experiment will take maximal 1 hour,
including rest periods, per subject, during which the subject is asked to walk
six two-minute rounds on a treadmill, with a comfortable speed. This while
wearing the sandals, with bare feet. Because the walking during the experiment
differs from a natural situation, the subjects might need some minutes of
walking to adjust to the new situation. The researcher will be with the
subjects during the experiments at all times. During three of the six walking
rounds, a perturbation will take place in the form of a short lateral push. The
duration of this push will be 0,10 seconds and the magnitude will be determined
prior to the walking trials. The disturbance is not painful and does not lead
to falling or stumbling in adults. The disturbance is corrected within one
stride. The correct magnitude of the push for elderly will be determined by
determining the magnitude which shows a perceivable balance disruption. The
magnitude will be increased per push with 1% of the subject's weight, starting
with 1% of the subject's weight, until the optimal magnitude is reached.
Although the perturbation will be very small, the risk of falling is slightly
increased. Falling is prevented by letting the subjects wear a safety gear,
which is attached to the ceiling. This safety gear is comparable to a safety
belt and does not feel uncomfortable. The vibrating insoles used during the
walking experiments are activated with the aid of an external current, coming
from a battery. Since a battery is used, there is no change the subjects will
come in contact with the AC. Nevertheless, during the sensory threshold test,
it will be determined by the researcher whether or not the vibrating insoles
cause redness at the foot soles of the subjects. If this is the case, the
experiment is aborted. If the subject feels any current at any moment during
the tests, the experiment will be ended as well. In a previous study, Hijmans
used the same characteristics of the vibrations and did not notice any redness
and the subjects did not feel any current.
Between subjects, the sandals will be cleaned with a disinfectant.
Nederland
Nederland
Listed location countries
Age
Inclusion criteria
For elderly subjects:
- older than 72 years
- able to stand and walk unassisted for ten minutes
For younger subjects:
- between the age of 20 - 40 years
- not suffering from a disease that can affect the tactile feedback from their lower limbs
Exclusion criteria
- diabetes
- severe pain during walking
- using a walking aid
- amputation of the lower limbs
- history of stroke
- using a lower limb orthosis / orthopaedic footwear
Design
Recruitment
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 | NL30733.042.09 |