Influence of a wearable soft robotic glove on functional ability of the arm/hand in stroke patients

The upper limb is one of the most frequently affected parts in stroke patients.
Since upper limb function is essential to perform independent activities of
daily life (ADL), the recovery of both arm and hand function is an important
goal in stroke rehabilitation. To stimulate the recovery of arm and hand
function, the rehabilitation of stroke patients should consist of
high-intensity, task-specific and functional exercises with active contribution
of the patient. New technological innovations can support functional
performance of the arms and hands directly by a wearable robotic device
assisting a person*s own function, which is expected to enhance functional
independence. Even more, with such wearable devices for daily use of the arms
and hands, a large variety of functional activities is enabled, turning
everyday activities into extensive training, independent from the availability
of healthcare providers. In this way, it is even conceivable that arm and hand
function may improve after prolonged use of such an assisting device

The primary objective of this study is to explore user acceptance of the HiM
system in the usability study and to examine changes in functional use of the
hand during ADL after prolonged use of a wearable robotic device by stroke
patients in the intervention study.. Secondary objectives are to examine actual
use and the impact on quality of life of such a wearable robotic device in
stroke patients. Furthermore, we will compare the effect of prolonged use of
the device in ADL at home with applying the HiM system as a training tool in a
clinical setting.

The study will consist of both a usability study and a randomized prospective
intervention study (clinical trial).

In the usability study, the stroke patients will perform independently a
selection of functional tasks with and without the wearable robotic device in a
(semi)-controlled environment across two days, after which usability
experiences are examined.
In the effect study, one group (experimental group 1) will use the wearable
robotic device during ADL at home and the other group (experimental group 2)
will use the wearable robotic device combined with Inertial Motion Units (IMUs)
as a training tool only in a clinical setting, both for 6 weeks. In
experimental group 1, chronic stroke patients are recommended to use the
wearable robotic device for 180 minutes a week during ADL at home. The chronic
stroke patients in experimental group 2 will receive game exercises training
for the hand and arm 3 times a week 60 minutes while wearing the robotic device
to support hand opening and strength. The glove and IMUs control the hand and
arm movements of the game exercises on a screen. Experimental group 2 will also
get to opportunity to use the wearable robotic device during ADL at home in the
last week (week 6) in addition to their training in-clinic.

The wearable robotic device might have a beneficial effect on hand function. It
might 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 major
research question addressed in this study.
The risks for the subjects are limited to a minimum. The wearable robotic
device 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 wearable robotic device 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. Furthermore, in case of the training group,
there will be supervision by a therapist. In case of the home use group, remote
monitoring is in place in addition to multiple contact moments between user and
researchers, to make sure the participant is doing well. Additionally, all the
evaluation measurements used in these studies are non-invasive and involve no
risks for the subjects.