The main goal of this study is to evaluate whether the performance in daily life grasping tasks, performed with a myoelectric prosthesis, increases when vibrotactile feedback about hand opening and grasping force is provided. Furthermore, the effect…
ID
Source
Brief title
Condition
- Other condition
- Congenital and hereditary disorders NEC
Synonym
Health condition
amputatie van de onderarm
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter of this study is the performance in grasping tasks.
Performance will be expressed by: (1) the time needed by the subjects to
perform the grasping task, (2) the success in grasping (percentage of objects
that is handled without object slippage or breakage), and (3) the Index of
Functionality (IoF), which is the outcome parameter of the SHAP test, which is
part of the test protocol.
Secondary outcome
The secondary outcome parameters will provide information about the performance
of the separate feedback methods (hand opening en grasping force feedback). To
evaluate the effect of hand opening feedback, the performance in situations
with and without visual feedback will be compared (primary study parameters).
The effect of grasping force feedback will be determined by the the number of
trials needed by the subjects to succesfully perform the grasping task and the
excess of grasping force that is applied to hold the objects. The combination
of hand opening and grasping force feedback likely also provides information
about the stiffness of an object. This effect will be evaluated with the
percentage objects that is correctly identified (size, weigth and stiffness) by
the subjects.
Background summary
The number of myoelectric forearm prostheses that is being used on a daily
basis is still quite low, while the functionality of these prostheses
continuously increases. One of the main reasons for prosthesis abandonment is
the lack of sensory feedback about the hand opening and the grasping force of
the prosthesis. One of the possibilities to provide this missing sensory
feedback to the prosthesis users is by vibrotactile stimulation. In earlier
studies we already proved that the use of an array of coin motors (small
vibrating elements) to provide hand opening feedback and a somewhat larger C2
tactor to provide grasping force feedback increases the performance in virtual
grasping tasks. To really prove the usability of this feedback in daily life,
we will evaluate the performance with the feedback in grasping tasks that are
more related to daily life activities. Subjects will perform these tasks with
and EMG controlled myoelectric prosthesis.
Study objective
The main goal of this study is to evaluate whether the performance in daily
life grasping tasks, performed with a myoelectric prosthesis, increases when
vibrotactile feedback about hand opening and grasping force is provided.
Furthermore, the effect on performance will be evaluated for the feedback
methods (hand opening and grasping force feedback) separately.
Study design
The main research question is: Will vibrotactile feedback about hand opening
and grasping force increase the performance in grasping tasks in comparison to
situations without vibrotactile feedback. Therefore, the performance in
grasping tasks will be compared between situations with and without
vibrotactile feedback. Furthermore, the performance in situations with and
without visual feedback (in combination with and without vibrotactile feedback)
will be investigated, because especially in situations without visual feedback,
the hand opening feedback should be of additional value. The feedback
configurations will be varied within three tests: (1) the SHAP test, which is a
highly standardized test for the evaluation of performance with hand
prostheses, (2) a grasping task where delicate objects, that can be found in
daily life, have to be transferred and (3) a grasping task where abstract
objects with varying weights, sizes and stiffness have to be hold. All subjects
will experience the same feedback conditions and therefore this study can be
regarded a monocenter experimental study.
Intervention
While performing the grasping tasks, in some cases vibrotactile feedback about
the hand opening and grasping force will be provided to the subjects through
vibrotactile stimulation. Hand opening feedback will be provided via an array
of small vibrating elements (coin motors), whereby activation of a single coin
motor corresponds to a certain level of hand opening. Grasping force feedback
will be provided by a somewhat larger vibrating element (C2 tactor), which
amplitude of stimulation is related to the level of applied grasping force. All
vibrators will be implemented in a sleeve (healthy subjects) or a prosthesis
socket (patients), which will be worn by the subjects.
Study burden and risks
There are no serious risks involved in this study. Due to the long-term
vibrotactile stimulation it is possible that the skin wil become irritated, but
these effects will not be long lasting. The burden for the subjects will be
mainly determined by the duration of the experiment. For both studies, the
experiments will take about 2 hours (including instructions and other
preparations). The healthy subjects of study 1 will get a training session of
maximally 1/2 hour. For the patients of study 2, a user specific prosthesis
socket will be made and therefore, the patients will be asked to come the RRT
(Roessingh Revalidatie Techniek) some time before the experiments to take
measures for this, which will take about 1/2 hour.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
age between 18 and 65
able to control the measurement setup
forearm circumference between 24 and 28 cm (healthy subjects)
forearm stump of at least 8 cm (patients)
myolectric prosthesis user (patients)
Exclusion criteria
extreme skin problems at the forearm
mental problems (when they cannot understand the procedures)
self-reported diminished sense of touch (healthy subjects)
experience with vibrotactile stimulation (healthy subjects)
experience with EMG control of a prosthesis or other device (healthy subjects )
hypersensitivity of the skin of the stump (patients)
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 | NL44020.044.13 |
| OMON | NL-OMON20497 |