In the last few years, due to limited resources, stroke patients hospitalization has been
progressively shortened with the increasing shift of some rehabilitation procedures towards
outpatient settings. This led to a high percentage of discharged patients who doesn't receive
an adequate amount of rehabilitation. This was because of some non-clinical factors, such as
resources availability, geographical location, age and personal wealth. Unfortunately, the
benefits gained during inpatient rehabilitation are often not sustained in the long term.
Thus stroke patients progressively decrease their activity level leading to functional
deterioration. To face these difficulties, telerehabilitation may be useful to deliver
rehabilitative treatments to homebound subjects with no moving of therapists or patients. To
date some studies highlighted that rehabilitation delivered from-distance has similar results
of face-to-face one, confirming that telerehabilitation may be effectively used to address
the growing call for improving home care. Despite these observations, telerehabilitation is
still few integrated into outpatients territorial rehabilitative practice. Furthermore, the
current literature about telerehabilitation is mainly focused on a single domain of
intervention (i.e. motor, cognitive, speech), with scant data about the impact of
telerehabilitation on global disability. Finally, the cost-benefit ratio of
telerehabilitation, compared to usual territorial rehabilitation or prolonged
hospitalization, still objects of debate.
Preliminary Data:
Previous literature about telerehabilitation evidenced an improved upper limb motor function
with positive interaction stroke patient-therapist. A previous RCT evidenced similar recovery
of motor performances in stroke patients who received telerehabilitation compared to "face to
face" treatment. Moreover, was highlighted that patients treated with telerehabilitation were
able to have good management of the system and a good relationship with therapists. Recently
was showed feasibility and effectiveness of speech telerehabilitation, applied to lexical
deficits in chronic stroke patients as well as of cognitive telerehabilitation in people with
mild cognitive impairment, with results similar to "face-to-face" treatment.
In a systematic review on motor telerehabilitation, was supported the equivalence of "face to
face" and "from a distance" delivery of neuromotor rehabilitation, showing no difference as
to the effect of telerehabilitation compared to other rehabilitative interventions in
neurological diseases. Furthermore, within the framework of an EU FP7 project focused on
Integrated Home Care, was performed a review on home care in stroke patients, evidencing
relevant suggestions to plan telerehabilitation trials, in order to observe the expected
effectiveness from a multi-domains point of view in clinical, financial and social
perspectives.
A multi-domain Health Technology Assessment approach was set up by the Istituto Superiore di
Sanità (ISS), validated and implemented within the EU Project CLEAR. The model, a
specialization of EUnet Health Technology Assessment model to telerehabilitation services,
was applied to a 960-patients Pilot study in 4 EU Countries to address remote rehabilitation
and management of several chronic neurological and motor diseases and was found appropriate
for the purpose. The above ISS Health Technology Assessment model proved to have the
potential to investigate telerehabilitation services in agreement with the Italian Guidelines
on Telemedicine. Highly relevant, it allows exceeding the boundaries and limitations of a
specific Hospital-based Health Technology Assessment, thus reaching the more general level of
a national-based Health Technology Assessment.
This clinical study with medical device, multicenter, randomized controlled trial with
blinded evaluation (single-blind, i.e. the evaluating doctor will be blinded) on cerebral
stroke patients, will have the following aims:
Primary objective
• Verify the non-inferiority from the point of view of post-treatment clinical efficacy, in
terms of motor, cognitive and language functions, of a "multidomain" telerehabilitation
protocol compared to conventional outpatient rehabilitation management in brain stroke
patients. The lack of statistically significant differences between the two groups regarding
the effects of the treatment for each treated domain will be considered an indication of
non-inferiority.
Secondary objectives
Verify the non-inferiority from the point of view of clinical efficacy 4 weeks after the
end of the treatment, in terms of the motor (assessed with Fughl-Meyer assessment),
cognitive (Oxford cognitive screen) and language functions (Aachener Aphasia Test), of a
"multidomain" telerehabilitation protocol compared to taking charge Conventional
outpatient rehabilitation in patients with brain stroke outcomes.
Compare the effects of a "multidomain" telerehabilitation with a conventional
rehabilitation treatment in terms of disability (Barthel Index) and quality of life
(Beck Depression Inventory scale, il Short-Form-36 health outcome, la Perceived Disease
Impact Scale, la Caregiver Burden Inventory) after post-treatment and 4 weeks after the
end of the same.
Compare a "multidomain" telerehabilitation treatment with a conventional rehabilitation
treatment based on an accurate economic analysis in terms of cost-effectiveness,
cost-benefit and cost-utility.
Evaluate the role of "multidomain" telerehabilitation in terms of ease of use, clinical
efficacy and cost-effectiveness (Satisfaction Measure Questionnaire, Hospital
Readmission Rate, la Service Problem Form e Cost and Time Form) by comparing patients
suffering from cerebral stroke results discharged early from the hospital (duration of
hospitalization less than 4 weeks) with those discharged after a prolonged
hospitalization (duration of hospitalization longer than 4 weeks). In this regard,
hospital stay days (stroke units and neurorehabilitation) will be considered.
The inclusion and exclusion criteria are described in the dedicated section, as the
description of the outcome measures also.
Once informed consent is obtained for participation in the study, patients will be randomized
to conventional rehabilitation therapy or telerehabilitation.
Patients in the telerehabilitation experimental group will undergo 20 sessions (1 hour a day,
5 days a week for 4 consecutive weeks) of "multidomain" telerehabilitation (motor, speech
and/or cognitive) with VRRS, K-Wand and Khymu connected to a workstation (Telecockpit):
VRRS is a medical device to perform cognitive telerehabilitation and home speech therapy
in online mode (the therapist connects via a telecockpit with integrated video
conference and takes remote control of the device at the patient's home interacting with
it in real-time) or offline ( the patient performs the personalized card of exercises,
guided by a virtual assistant called "Smart Virtual Assistant" who is able to accompany
him interactively in real-time throughout the duration of the rehabilitation treatment
session).
K-Wand is an additional device to VRRS for motor telerehabilitation of the upper limb
and trunk. It works with a set of motion sensors through light recognition technology.
Khymu is a set of sensors added to the VRRS used to carry out motor telerehabilitation
activities of the lower limb. The use in combination with the K-Wand is able to allow
"full-body" motor telerehabilitation.
Patients will have at their home a special workstation connected to the internet. The same
equipment will also be present in the reference structure. As part of the study protocol,
only the online telerehabilitation mode will be used, with a direct and bidirectional
connection between the two devices, also including an audio and video teleconference. The
rehabilitator will be able to remotely control the patient's system: send the exercises
necessary for online treatment, check its execution on its own screen, modify them according
to clinical needs and monitor the patient's activity thanks to the camera. The patient, in
turn, will see on his screen the exercises to be performed, their realization and the results
achieved by seeing and listening to the operator who is following him.
For motor treatments, the patient will have to move the end-effector (object or limb)
following the trajectory of the corresponding virtual activity displayed on his screen.
Cognitive exercises will focus on attentional skills and executive functions.
The rehabilitation of language will be based on exercises of interpretation and production of
written and oral words.
With regard to patients assigned to the conventional therapy group, they will undergo 20
sessions (1 hour a day, 5 days a week for 4 consecutive weeks) of "multidomain"
rehabilitation (motor, speech and/or cognitive) according to a conventional regime approach
outpatient. Currently, it is not possible a priori to precisely define the instruments that
will be used during rehabilitation management. These, in fact, will have to be defined on a
case-by-case basis on the basis of the physiatric visit and the rehabilitation team's
project/intervention program, which is periodically updated to follow the different phases of
the patient's clinical evolution. Therefore, the telerehabilitation or conventional treatment
methods that will be put in place (the type of therapeutic exercise, the modality of
cognitive stimulation and/or taking care of speech therapy) will be determined for each
patient on the basis of the needs emerging from the physiatric examination performed at T0,
defined according to the Individual Rehabilitation Project and applied according to each
Rehabilitation Program (motor, cognitive and/or speech therapy) periodically updated.
Sample size estimation Considering the main outcome measure, the level of functional
impairment measured at the FMA, and referring to a Cohen effect-size d of 0.64 calculated on
the basis of the data reported on this regard in the literature, telerehabilitation group
53.6 (7.7) and conventional group 49.5 (4.8) [1], given an alpha level of 5%, the two-tailed
Mann-Whitney test and a power of 80% (ß), was calculated that a sample size of 82 patients
(41 subjects per group) may be sufficient to observe any significant difference between the 2
groups.
Taking into account a possible drop-out rate of about 10%, the sample size was increased by 4
subjects per group, arriving at a final calculation of 90 patients (45 subjects per group) to
be enrolled. The calculation was made using the statistical program PASS 14.0.8.
