Armed4Stroke: Allied Rehabilitation using Medical Devices for Stroke

Several systematic reviews have indicated that additional exercise therapy and
repetitive task-oriented training have a significant effect on functional
outcome after stroke. (4-6) Exercise therapy typically focuses on restoring
and/or improving motor function, especially recovery of walking ability is an
important goal for patients post stroke. Stroke rehabilitation and exercise
therapy is typically front loaded, with resources mainly focused on inpatient
care. Consequently, stroke survivors and their caregivers experience the
transition from inpatient care to the community as a significant hurdle.
Support tapers off and the majority of stroke survivors become physically
inactive. The Armed4Stroke program is directed at training caregivers as
co-therapist to increase the level of exercises at home and to smoothen the
transition from inpatient rehabilitation to the community.

The primary objective of the present study is to assess the added values of
using tele-rehabilitation services, combined with caregiver mediated exercises
to improve the level of self-reported mobility at home. Secondary objectives
are to assess the added value of the Armed4Stroke on length of inpatient stay,
activities of daily living and psychosocial measures.

Single blinded randomized controlled trial

The Armed4Stroke program consists of eight weeks of complementary exercise
therapy done with a caregiver, supported by tele-rehabilitation, next to the
usual therapy. The couple has regular face-to-face sessions with the physical
therapist. The web based tele-rehabilitation system is complementary to the
face-to-face support. Through this system, the patient can communicate
a-synchronically with the physical therapists. This communication takes place
in a messaging environment, which means that communication takes place through
the exchange of text messages.

When the Armed4Stroke program is followed according to protocol, patients will
have a surplus of 150 minutes of training per week. Literature shows this
intensity to be beneficial for functional outcome after stroke. In addition,
caregivers will be involved in rehabilitation and will most likely feel more in
control, which might smoothen the transition from inpatient care to the home
situation.
The therapist can tailor the exercise program to individual patient and
caregiver goals. Given the experience gained in a previous study, the
intervention can be considered safe for both patients and caregivers. The small
risk of adverse events will be minimized since a therapist will judge if the
caregiver can adequately and safely assist the patient during exercises before
inclusion. In addition, safety instructions are provided in the
tele-rehabilitation system and there is close guidance of a therapist during
the intervention period. Also, instructions are described regarding what to do
in case of an adverse event. The control group will have no additional benefit
or risks. Assessments will take place at baseline, after the intervention and
at 6 months after randomisation. They consist of questionnaires and functional
tests, taking approximately two hours per assessment. All participants will be
asked to keep an exercise diary during the 8-week intervention or control
period. Number of falls will also be asked in the diary. If the patient will
be discharged during the course of the study, we will ask you to complete 1
additional questionnaire during the week of discharge and 3 months after the
discharge. They do not have to come to the rehabilitation center especially for
this.