The primary objective of this study is to examine the direct influence of the grasp support system on (functional) performance and movement execution of the most-affected arm and hand. Secondary objectives are to examine the direct effect of the…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are outcomes related to (functional) task performance
and movement execution. To examine the direct influence of the grasp support
system on (functional) performance of the most-affected arm and hand during the
different proposed conditions, the following main study parameters will be
measured:
* Qualitative observations of functional task performance and movement
execution (e.g. speed of movement, precision, fluidity, compensatory movements)
* Quantitative parameters of functional task performance and movement execution
(e.g. performance time, kinematics of hand and arm joints, movement path,
velocity (profile), acceleration and jerk)
Secondary outcome
To explore user acceptance of the grasp support system and to examine the
direct effect of the grasp support system on changes in hand strength and
movement execution, the following parameters will be registered during the
measurements:
* System Usability Scale (SUS)
* Semi-structured interview about user*s experience
* Action Research Arm Test (ARAT)
* Maximal pinch force (Jamar pinch Gauge dynamometer)
Background summary
Stroke survivors frequently experience difficulties with performing activities
of daily living (ADL) due to a decline in hand function. They often need
personal and/or assistive devices to carry out ADL. However, personal
assistance will not result in more independence in performing ADL while
assistive devices have the potential to provide the assistance that is
necessary to perform ADL independently. New technological innovations can
support the functional performance of the arms and hands directly by a wearable
soft robotic device assisting a person*s own function. If people can maintain
or increase use of their hands/arms in daily life, this might ultimately even
benefit their (unsupported) arm function in ADL.
Study objective
The primary objective of this study is to examine the direct influence of the
grasp support system on (functional) performance and movement execution of the
most-affected arm and hand. Secondary objectives are to examine the direct
effect of the grasp support system on hand strength and to explore user
acceptance of the grasp support system.
Study design
This observational, cross-sectional study will consist of one visit.
Intervention
Stroke survivors will perform several hand function tasks and clinical tasks
with and without the wearable robotic device to assess the direct influence of
the device on functional task performance, ability to perform functional tasks
and user acceptance.
Study burden and risks
The grasp support system might have a beneficial effect on hand function, by
directly improving functional task performance. However, the exact benefit
cannot be predicted, because this is the topic of the current research. The
risks for the subjects are limited to a minimum. The grasp support system is a
device that facilitates hand grip and opening as initiated by the user
him/herself. It provides support only when necessary based on voluntary, active
initiation by the person him/herself. Furthermore, the grasp support system is
a so-called soft-robotics device, constructed from soft materials that are
comfortable to wear and compliant with human movement. This prevents potential
occurrence of pressure points for example. All movements conducted during the
study will consist of arm/hand movements that normally occur in ADL and within
the abilities of each individual. Additionally, all the evaluation measurements
used in these studies are non-invasive and involve no risks for the subjects.
Roessinghbleekweg 33b
Enschede 7522 AH
NL
Roessinghbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
* Patients should be clinically diagnosed with unilateral ischemic or hemorrhagic stroke
* Between 18-80 years of age
* Time since onset of disease is at least three months
* At least 10 degrees of active flexion and extension of the fingers
* Sufficient cognitive status to understand two-step instructions
* Having (corrected to) normal vision
* Provided written informed consent
Exclusion criteria
* People with severe sensory problems of the affected upper extremity
* People with severe acute pain of the affected arm
* People who participate in other studies that can affect functional performance of the arm and hand
* People having insufficient knowledge of the Dutch language to understand the purpose or methods of the study
* People with severe contractures limiting passive range of motion
* People with co-morbidities limiting functional use of the hand
* People with wounds on their hand that can give a problem when using the system
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 | NL58778.044.16 |
| Other | Wordt nog aangemeld bij NTR |
| OMON | NL-OMON20789 |
| OMON | NL-OMON20620 |