REWIRE - Rehabilitative Wayout In Responsive Home Environments, A Pilot Trial
REWIRE - Rehabilitative Wayout In Responsive Home Environments, A Pilot Trial
The study examines the possible application of the rehabilitation platform REWIRE.
The REWIRE rehabilitation platform consists of three hierarchical components: the "Patient
 Station" (PS), which is installed in the home environment of the patient; the "Hospital
 Station" (HS), which allows an exchange of information with more horsepower and is served by
 the therapists in the hospital; and the "Networking Station" (NS), which allows a combination
 of a plurality of HS.

 The PS consists of a standard laptop with a specifically created for the rehabilitation
 REWIRE platform and pre-installed software (Università degli Studi di Milano, Italy, Applied
 Intelligent Systems Laboratory Department of Computer Science). In the context of a training
 system connected to the computer, the software enables the collection of data, which are
 recorded as part of the training. In this study only exercises for balance ability are part
 of the training program. The training system consists of a so-called Tymoplate® (Tyromotion,
 Austria), a medical device class 1 with CE certification and approval by the FDA for use in
 neurorehabilitation after stroke. The Tymoplate® is connected to the computer and allows by
 means of a base plate with integrated pressure sensors and custom-developed training
 software, various postural biofeedback exercises. In combination with 3D cameras (Kinect®,
 PrimeSense, CA, USA), the patient sees him-/herself or an avatar in real time on a screen
 which moves in the virtual training environment. By various, attractive and entertaining
 designed training games as well as provided audio-visual feedback and balanced score system,
 patients should be maximum motivated to exercise.

 The HS enables the interaction between patient and therapist and essentially consists of a
 MySQL database with web-based interface. The data collected on each PS can be retrieved from
 the HS and can be used by therapists in order to set up the training program on the PS to
 control and to adjust the difficulty level of the exercises to the individual performance of
 each patient.

 The NS also consists of a database. It links collected training data and the associated
 epidemiological data of different HS at the regional level (potentially also between
 different health institutions) to identify on the application of statistical algorithms
 general models for the description of relaxation processes in rehabilitation medicine.

 In this simple way a frequent and intensive training is without direct therapeutic help in
 the home setting at low cost possible. By attractive and entertaining designed training games
 as well as interaction and feedback by the therapist, patients are motivated to train each
 day with the system and to continually improve in the games. The supervision of the training
 by the therapist with the rehabilitation platform REWIRE additionally serves to recognize
 improvements of the individual performance or problems and to adapt the difficulty level of
 the exercises.

 For Patient Registries

 -  Patient recruitment Suitable stationed patients at Cereneo in Vitznau will be informed
 about the possibility of participation in the study. If interested, the patients will
 receive the patient information and can decide within a week whether they will
 participate in the study.

 -  Data collection We will collect data on daily usage of the patient as well as hospital
 stations. Patient usage will be regressed on the patient's deficit severity, age and
 gender to gather preliminary knowledge on whether certain subgroups of patients accept
 the system better than others.

 System usability During and after the pilot trial all involved physicians and physical
 therapists will answer a standardised questionnaire on system usability. Specifically we will
 look at the number of instructions and therapy modifications given to the patient and whether
 the therapist giving the instruction thinks that the patient has reacted accordingly. REWIRE
 will be also evaluated, in terms of usability of software instruments, degree of control of
 the rehabilitation process and value of the results reported by REWIRE.

 - Data management The investigators will use paper case report forms (CRF), one for each
 enrolled study participant, to be filled in with all relevant data pertaining to the subject
 during the study. The investigator will document the participation of each study subject on
 the enrolment log.

 All requested information in the CRF should be completed in a neat legible manner. Use of a
 black ball pen is recommended to ensure clarity of reproduced copies in the CRF. All
 corrections in a paper CRF must be made in a way that does not obscure the original entry.
 The correct data must be inserted, dated and initialled by the investigator Data that are not
 available or not done should be made clear by adding NA or ND. A declaration ensuring
 accuracy of data recorded in the case report forms must be signed by the investigator.

 CRFs will be kept current to reflect subject status at each phase during the course of study.
 Subjects will not to be identified in the CRF by name. Appropriate coded identification (e.g.
 subject number) will be used.

 It will be assured that any authorised person, who may perform data entries and changes in
 the CRF, can be identified. A list with signatures and initials of all authorised persons
 will be filed in the study site file and the trial master file, respectively.

 Documented medical histories and narrative statements relative to the subject's progress
 during the study will be maintained. These records will also include the following: originals
 or copies of laboratory and other medical test results which must be kept on file with the
 individual subject's CRF.

 The CIP will specify what will be maintained for each subject. The investigators assure to
 perform a complete and accurate documentation of the subject data in the CRF. All data
 entered into the CRF with exception of (for which data the CRF will be source data to be
 specified for each study) must also be available in the individual subject file either as
 print-outs or as notes taken by either the investigator or another responsible person
 assigned by the investigator.

 Data which is not included in the CRF will be stored in a secured access database.

 Essential documents must be retained for at least 10 years after the regular end or a
 premature termination of the respective study (VKlin Art. 25). Essential documents will be
 retained according to local law in case of international multicentre studies.

 Any patient files and source data must be archived for the longest possible period of time
 according to the feasibility of the investigational site, institution or private practice.

 -  Reporting for adverse events Adverse events will be reported to the Ethics Committee
 northwest/ central Switzerland EKNZ.

 -  Change management Sample size assessment to specify the number of participants or
 participant years necessary to demonstrate an effect Number of patients: 15 stroke
 patients. Due to the likely large heterogeneity of the study population (different
 weights severity of paresis and ataxia, as well as partly cognitive deficits) a
 sufficiently large number of patients must be tested. Currently, there are no data which
 would allow a power analysis with respect to the primary or secondary end point. In case
 of premature withdrawl from the study, those participants will be replaced so that at
 least 16 participants carry out the 3-month training program completely.

 Plan for missing data to address situations where variables are reported as missing,
 unavailable, "non-reported," uninterpretable, or considered missing because of data
 inconsistency or out-of-range results If in individual clinical tests the data is missing,
 the concerning test cannot be analysed and will not be considered.

 Statistical analysis plan describing the analytical principles and statistical techniques to
 be employed in order to address the primary and secondary objectives, as specified in the
 study protocol or plan Primarily, the feasibility of the technical and practical
 implementation of the rehabilitation REWIRE platform will be evaluated in the
 home-environment of the study participants. Furthermore, the satisfaction and patient
 compliance and acceptance of the system by the attending physicians and therapists will be
 measured. Therefore, structured-standardized questionnaires are used and the quality (if
 numerically tangible) will be evaluated by means of Likert scales. Secondary, the effects to
 use the training system on the functional recovery and quality of life as well as on the
 structural plasticity of the brain will be evaluated. In terms of functional recovery and
 quality of life correlation analyses will be performed. Related data from stroke patients
 (from the stroke registry ZORRO, KEK-ZH-E-08/2009) will be compared with those from the
 REWIRE-study. The evaluation of the data measured by means of magnetic resonance imaging,
 require before carrying out a correlation analysis the application of parametric statistical
 methods.
Inclusion Criteria:

 -  Age ≥ 18 years

 -  First-time ischemic stroke

 -  Moderate, residual motor deficits of the lower extremity (FAC> 3, 6-min walk ≥ 200 m;
 Berg Balance Scale 21-52)

 -  Ability and willing to participate in the study

 -  signed consent form

 Exclusion Criteria:

 -  Other neurological disorders (eg Parkinson's disease, dementia, multiple sclerosis,
 peripheral nerve damage, etc.)

 -  Moderate to severe aphasia

 -  moderate to severe unilateral neglect

 -  Severe dementia, MMSE ≤ 20 points

 -  Severe depression or psychiatric disorders

 -  Other serious diseases, such as severe kidney or liver dysfunction, or serious
 dysfunction of the cardiovascular system

 -  Relevant loss of vision that can not be compensated by aids, eg Hemianopia, visual
 acuity ≤ 20%

 -  Severe pain,> 6 points on the visual analog scale

 -  Pregnancy