Feasibility of the Supervised Care & Rehabilitation Involving Personal Tele-Robotics active-actuated arm/hand training system at home after chronic stroke

After experiencing a stroke, the majority of people have to cope with impaired
arm and hand function. Post-stroke rehabilitation training aims to regain arm
and hand motor function, which is essential to perform most activities of daily
living (ADL) independently. To stimulate restoration of arm function after
stroke, intensive, task-specific training with active contribution of the
patient is essential. The application of robotics in rehabilitation to promote
this repetitive training is promising. Most research involving robotics so far
has demonstrated significant improvement in upper limb motor function by
participants, but limited studies have showed improvements in ADL. In the
SCRIPT2 project we are developing robotic technologies for home rehabilitation
to enable self-administration of more intense and more frequent exercises,
specifically of the hand and wrist with the goal of contributing to the
personal independence of stroke patients.

The primary objective of this study is to examine user acceptance after
technology-supported arm/hand training using the active-actuated orthosis at
home by chronic stroke patients. Secondary objectives are to examine whether
stroke patients increase their total amount of practice when provided with the
opportunity, examine if (additional) training enhances changes in arm/hand
function and to explore which factors contribute to this. In addition, we will
examine differences in orthotic effect between passive and active versions of
arm/hand support on movement performance and motor control.

This explorative feasibility study has a longitudinal design. Evaluation is
based on one baseline measurement pre-training, and one evaluation measurements
within one week post training.

Subjects will be recommended to exercise 180 minutes per week (6 days, 30
minutes/day) with the SCRIPT2 system at home, during 6 weeks. They will train
their arm and hand using games via the patient user interface, while wearing an
active-actuated orthosis which supports wrist extension and hand opening, and
wearing the SaeboMAS for gravity compensation of the proximal arm. During the
six weeks of training, they will be remotely supervised, off-line, by a
therapist.

Participation in this study can provide an immediate benefit for the subject,
in providing the opportunity for additional, self directed rehabilitation of
the affected arm and hand. The extent of this benefit cannot be predicted,
obtaining these insights is one of the purposes of this study.
The risks for the subjects are minimum, since the movement tasks consist of
functional and familiar arm and hand movements and are performed within the
ability of the subject, while he/she is seated. During training, subjects will
wear the SCRIPT2 active-actuated orthosis. This is an exoskeleton which
interacts with the human body by providing forces to the wrist and hand through
springs in series with small servo motors in a series-elastic actuation (SEA)
configuration. The joint torque is controlled and limited to prevent excessive,
forced movements. The device has several safety stops and it can only operate
within safe movement and force range for the individual user. The amount of
support can be adjusted to provide more or less offset force to wrist or finger
extension. The available power in the actuator is limited, it can produce at
most 0.3Nm, which is not sufficient to cause severe injuries. Besides, patients
are not able to change the amount of support by themselves. The torque will
only be adjusted by an experienced HCP over rehabilitation sessions, based on
the patient*s progress as monitored by the system and observed during weekly
home visits.
The recommended training sessions will be spread throughout the week to
minimise the burden for the subjects. Besides, the subjects will be monitored
by a HCP for signs of overloading. In addition, the outcome measurements used
in this study during the evaluation measurements (movement analysis, functional
scales) are all non-invasive and involve no risk for the subjects.