Influence of assistive soft-robotic glove use on actual arm use in daily life

Hand rehabilitation after neurologic or orthopaedic disorders/injuries can only
achieve so much and chronic hand dysfunction with mild disability often
persists. Tools such as adaptive clothing, shower accessories, one-handed can
openers etc., can compensate for functional limitations, but these often avoid
active involvement of the affected body parts. With rapid developments in the
field of advanced soft-robotic devices, assistive robotic devices are becoming
available to be applied in real life situations, in unsupervised setting such
as peoples* homes. When an assist-as-needed approach is applied as the basis
for control of the glove, optimal, hybrid, support becomes possible: assisting
ADL where needed, while stimulating active and highly functional movements
within the user*s abilities. An example of a wearable soft-robotic glove, with
an assist-as-needed approach via movement intention detection, is Carbonhand
(Bioservo Technologies AG; Kista, Sweden), which supports grip by assisting
finger flexion. In previous studies we found that use of the Carbonhand system
as assistive device has a beneficial effect on hand function, by directly
improving functional task performance. Moreover, unsupported hand function also
increased after 4-6 weeks use of the glove. This therapeutic effect of
assistive use is believed to be related to people being enabled by the glove*s
assistance to use their affected hand more in daily life tasks than they did or
could without the glove*s support. If confirmed, an assistive soft-robotic
glove forms a powerful tool not only to provide direct support in ADL, but also
to enable patients to use their affected hands more in ADL. This turns use of a
smart assistive device into the highly intensive and functional training
integrated in daily life at home.

The primary objective is to examine the influence of assistive soft-robotic
glove use on actual use of the arm and hand in daily life. Secondary objectives
are to examine retention of the effect on arm use in daily life after cessation
of assistive soft-robotic glove use; to examine changes in (perceived) hand
function and well-being after using an assistive soft-robotic glove at home,
and it*s retention after cessation of glove use; to examine the relation
between glove use time, actual arm use in daily life and changes in (perceived)
hand function and well-being; to assess user experience and satisfaction with
regard to glove use (amount and activities), actual arm use in daily life, hand
function and well-being

A partially concurrent multiple baseline single case experimental design (SCED)
with three phases (baseline of 2-4 weeks, glove use at home during 6 weeks,
retention phase without glove use of 4 weeks), and randomized baseline length.
During this period, participants use the Carbon hand in daily life for 6 weeks
to support the performance of daily activities in the home environment. Here, a
diary is kept to record how much the Carbonhand is used and during which (type
of) activities. Repeated assessments of arm activity in daily life, grip
strength, perceived hand function and wellbeing are performed 1-2 times per
week by the subjects at home (with supervision from a researcher via
videocall), for a total of at least 15 times, throughout all three phases.
Besides the initial screening visit, additional assessments are scheduled at
the end of each phase (pre, post and follow-up assessments) with an extended
battery of hand function tasks and patient-reported outcomes related to
experiences during the study, (perceived) hand use, hand function and
functional ability, quality of life.

The SCED in this study will consist of three phases: a baseline phase (control
condition) of varying length (randomized between min. 2 weeks and max. 4
weeks), followed by a 6-week intervention phase, consisting of home use of an
assistive soft-robotic glove, and a subsequent follow-up phase of 4 weeks
without glove use to assess retention. All participants will use the Carbonhand
system during ADL at home for 6 weeks. The participants are free to choose for
which activities, when and for how long they use the Carbonhand. However, it is
recommended to use the Carbonhand at least 180 minutes a week during the most
common ADL, such as household activities, dressing/undressing,
eating/drinking/cooking, and/or leisure activities.

The risks for the subjects are limited to a minimum. The Carbonhand system is a
device that facilitates handgrip 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 Carbonhand 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 hand movements that normally occur in ADL and are within the
abilities of each individual. Additionally, all the evaluation measurements
used in these studies are non-invasive and involve no risks for the
participants. The burden for the participants is relatively high, with repeated
assessments (self-administered or with remote supervision) of 1-2 per week for
a duration of 12-14 weeks in total and 3 lab visits with 1-1,5h of additional
hand function tests and questionnaires. On the other hand, participants are
expected to experience a direct benefit in support during ADL when using the
soft-robotic glove, as well as an improved unsupported hand function, which
might persist up to 4 weeks at least. All participants will undergo the same
conditions, with the only difference the length of the baseline phase (varying
randomly between 2 and 4 weeks).