Remote handling concept based task-oriented arm training (ReHab-TOAT) in chronic stroke: an RCT

One of the major deficits after a stroke is sensorimotor impairment in the
contralateral limb. A majority of these stroke patients has limited use of the
affected upper limb. One year after stroke, motor impairment of the upper limb
is associated with anxiety, lower perceived health-related quality of life and
a reduced subjective wel]-being. lmproving arm-hand skill performance is a
major therapeutic target in stroke rehabilitation. However, treatment time and
financial resources are limited. In order to solve these problems, new
technology is being used to assist training of patients. By using
technology-assisted training, arm function training and arm skill training may
be augmented both in amount and duration of training as well as in content
richness / variety and task specificity, thus providing optimal conditions for
challenging the patient's brain plasticity regarding sensorimotor
(re-)learning, yet, at the same time keep the workload for (para-)medical staff
and treatment costs manageable.
We developed a new task-oriented arm training approach using a so-called
'remote handling concept', to manipulate proprioception. This approach is
called "Remote Handling concept based, Task-Oriented Arm Training" (acronym:
ReHab-TOAT). We hypothesize that, given the brain's plasticity, proprioception
manipulation during task-oriented training may lead to improvements of arm
function and arm skill performance, and, ultimately improvement of quality of
life in persons in the chronic stage after a stroke. We also assume that, when
patients* arm function improves, they may need less (and less frequent) care
from caregivers, which may lead to a lower level of perceived burden and
improved quality of life in caregivers.

The aim of the proposed RCT is to assess the effectiveness of the ReHab-TOAT
approach in improving arm function and arm skill performance in daily life
tasks in chronic stroke patients with either a severely or moderately affected
arm-hand (i.e. with an Utrechtse Arm test (UAT) score between 1-3). We also
want to gauge potential changes in patients* and caregivers* perceived quality
of life, and assess the patients* perception regarding the usability of the
technology used in ReHab-TOAT.

This randomized clinical trial features two arms (EXP and CONTR). The EXP group
will receive a 4 week ReHab-TOAT regime at a frequency of 3 sessions of 1.5
hours per week. This will be additional to any care the participants may
receive outside the research context. The EXP group will also receive 1
additional session to familiarize themselves with the training system, prior to
the start of the training phase. The CONTR group will not receive additional
arm-hand therapy apart from regular *maintenance* therapy, i.e. therapy
participants already may receive from therapists in their current home
situation (e.g. *1e-lijns* physiotherapy). For participants in both groups any
therapy they may potentially receive, will be inventoried and described. In our
protocol, no restrictions will be imposed on any (additional) therapies
participants currently receive.

The time and extent of care delivered to patients by their caregiver, as well
as quality of life of caregivers are also inventoried longitudinally.

Participants in the EXP group receive ReHab-TOAT (Remote Handling Based
Task-Oriented Arm Training). ReHab-TOAT contains task-oriented arm training for
stroke patients in combination with haptic feedback, generated by a remote
handling device. They will train for 4 weeks, 3x per week, 1.5hr per day.
Participants in the CONTR group will receive no additional arm-hand therapy
apart from regular *maintenance* therapy, i.e. therapy they may already receive
from therapists in their current home situation (e.g. *1e-lijns*
physiotherapy).

The present RCT will investigate the effect of ReHab-TOAT, additionally to any
therapy as usual, on improving arm function and arm skill performance in
chronic stroke patients with a moderately to severely affected arm-hand
function, regarding daily upper extremity tasks. It is hypothesized that
provision of enriched proprioceptive information during arm-hand skill training
in chronic stroke patients may lead to higher levels of arm function and arm
skill performance than a) arm function and arm skill performance levels in the
CONTR group, and b) pre-treatment levels of arm function and arm skill
performance in subjects in the EXP condition. Furthermore, it is hypothesized
that these higher levels of arm function and arm skill performance in the EXP
group will be maintained across at least a period of 9 months
post-intervention, and will be higher during the follow-up period (of 9 months)
relative to arm function and arm skill performance levels in the CONTR group.

The patient may benefit from this RCT because we are able to train his/her arm
in a more functional way, thereby increasing the chance of reaching a higher
level of functional outcome, enabling him to perform his daily activities
better and improving the patient*s quality of life. We also think that reaching
a higher level of functional outcome may lead to the burden caregivers may
experience in providing care may decrease and their quality of life may
increase. There are already several technology-assisted arm-hand training
programs that have been evaluated in clinical trials. None of them reported any
side effects. In our own pilot study (CCMO code: NL70014.015.19), involving
ReHab-TOAT, no adverse events were observed. Furthermore, given the low net
forces that will be exerted by the DexterTM on the patient*s arm (i.e. in the
order of 0 N - 20 N) during arm activities also performed in daily life, as
well as the many safety features installed, the risks in the present study are
estimated to be low. Additionally, all measures used in the present RCT pose no
harm to the participant. They are also used as regular clinimetrics in
rehabilitation.