The primary objective of this study is to explore user acceptance of the ironHand (iH) system by elderly. Secondary objectives are to examine the direct effect on functional task performance, changes in hand strength and movement execution of such a…
ID
Source
Brief title
Condition
- Other condition
- Age related factors
Synonym
Health condition
Handfunctie problemen bij veroudering
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are outcomes related to user acceptance (System
Usability Scale) in phase 1 and functional task performance (Jebsen-Taylor Hand
Function test) in phase 2.
Secondary outcome
Secundary study parameters are outcomes related to user acceptance, perceived
use and changes in hand motor function.
Background summary
Elderly people 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 explore user acceptance of the
ironHand (iH) system by elderly. Secondary objectives are to examine the direct
effect on functional task performance, changes in hand strength and movement
execution of such a wearable robotic device in elderly.
Study design
This observational, cross-sectional study will consist of two phases. Phase one
will focus on user acceptance and phase two on functional task performance.
Study burden and risks
The iH 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 iH 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 iH 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.
Roessinghsbleekweg 33b
Enschede 7522AH
NL
Roessinghsbleekweg 33b
Enschede 7522AH
NL
Listed location countries
Age
Inclusion criteria
• Elderly adults over the age of 55 years
• Experience difficulties in performing ADL due to their decline in hand function as result of aging
• Absence of wounds on their hands that can give a problem when using the glove
• Absence of severe contractures limiting passive range of motion
• Absence of co-morbidities limiting functional use of the arms/hands
• People should have 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
• Living at home
• Provided written informed consent
Exclusion criteria
• People with severe sensory problems of the affected hand
• People with severe acute pain of the affected hand
• Participation 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
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | in aanvraag NTR |
| CCMO | NL52324.044.15 |