The ironHand system integrates both support in ADL and functional training exercises to improve impaired hand function

Elderly people and patients with acute (e.g. stroke) or chronic (e.g.
arthritis) diseases frequently experience difficulties in 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. By integrating both an
assistive robotic device with exercise training, performance of ADL can be
enhanced directly and/or via an improved arm and hand function after prolonged
use of the hands.

The primary objective of the present study is to examine the orthotic and
therapeutic effect of the ironHand (iH) system, consisting of both an assistive
and therapeutic module, by elderly and diagnosed patients with hand function
problems, after using the iH system for a four weeks training period at home.
Secondary objectives are related to user acceptance, including usability,
satisfaction, motivation and compliance.

A randomized controlled trial design will be conducted, in which both the
elderly and patient population will be randomized into three groups; the iH
assistive group, the iH therapeutic group and the control group. Evaluation is
based on one baseline measurement and one evaluation measurement within one
week after the intervention period of four weeks

The intervention period for all three groups will last for a period of four
weeks. The iH assistive group will use the wearable robotic device during ADL
at home and the therapeutic iH group will use the wearable robotic device as a
training tool using games via the patient user interface. Participants of the
control group do not follow an intervention program. In the iH assistive group,
participants are recommended to use the wearable robotic device for 180 minutes
a week during ADL at home. The participants in the iH therapeutic group are
recommended to train the hand 3 times a week for 60 minutes by performing game
exercises while wearing the robotic device to support hand opening and strength
and to control the game exercises on a screen. During the four weeks
intervention period, all three groups will be monitored by a therapist.

The iH system may have a beneficial effect on hand function, by directly
improving functional task performance or by using it as a training tool. It may
be possible that the functional use of the hand improves, allowing people to be
more active in ADL and to maintain or improve their health status. 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.