Clinical trial NCT03964662: Stroke Home Rehabilitation With WeReha
Official title: A New Solution for Home Rehabilitation of Stroke Patients: WeReha
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Stroke
Keywords: home rehabilitation
technology
stroke
biofeedback
games
Lead sponsor: CoRehab s.r.l.
Sponsor class: INDUSTRY
Collaborators: name: Engineering Ingegneria Informatica SpA
name: Fondazione Bruno Kessler
First posted: 2019-05-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The goal of this study is to assess the acceptance and validity of a new technology such as WeReha for home rehabilitation of patients following a stroke episode either in sub-acute or chronic phase. The investigation will be conducted in two different countries: two sites in Northern Ireland and one in Italy.
Primary purpose: TREATMENT

Brief summary: WeReha is an innovative device for the home rehabilitation of stroke patients developed within the scope of the EU funded project MAGIC-PCP \[5\]. WeReha is a system that allows patients to perform exercises in a home environment with remote supervision integrated within regular rehabilitation. The principle on which the product is based is that of biofeedback guided rehabilitation, designed to stimulate muscle recovery and contribute to a more effective and more motivating rehabilitation of neuro-motor patterns. WeReha is completely adaptable, allowing only authorized to assign exercises, by planning specific sequences of movements.

WeReha product is composed by the following elements:

* a tablet with a proprietary application on it (the "WeReha app")
* an inertial sensor with accelerometers, gyroscopes and magnetometers (the "sensor")
* elastic straps allowing the user to wear it on different parts of the body (the "straps")
* a series of 3D printed objects where the sensor can be placed that become animated (the "smart objects")
* a web portal for clinical staff through which they can manage and monitor users (the "web-application") The WeReha app presents the patient with a series of rehabilitation exercises in the form of a number of interactive games, driven by body movement, which is captured by the sensor or the hand specific movements using the smart objects. A session with WeReha always starts with a questionnaire on the system, through which the software gains an understanding of the patient's health conditions and the presence or not of a caregiver for the session. Based on this questionnaire, the software adapts the daily session to minimise risks while maintaining a high level of rehabilitation to help the patient reach their goals. The device works with and without an internet connection, but when the device is connected to the internet, supervisors are able to provide supervision and remote support through a web application.

The web application is hosted on a dedicated server located inside the hospital. Only trained staff will be provided with access to the web application with a unique username and password required for sign on. The exercises assigned for the client to perform at home, are at the discretion of the clinician who is caring for the patient and might require the presence of a caregiver.

The goal of this study is to investigate the applicability and utility of an innovative technology product such as WeReha to the home rehabilitation of stroke patients as an integrative solution to a conventional exercise program and to assess its acceptance by the patient, caregivers and clinic professionals.

Patients will use WeReha for their home rehabilitation in addition to traditional treatments for up to 12 weeks. The Inclusion criteria for the study have been kept broad in order to assess these factors on a large enough scale, so as not to limit the usage of the device to a specific sub-group of patients. If patients enrolled are in a subacute phase (i.e. within the first 6 months after the stroke onset), they will be enrolled before leaving the hospital or the rehabilitation department and reaching their home. If patients are considered to be in their chronic phase (i.e. over 6 months after stroke onset), they will be enrolled during an outpatient treatment or on a volunteer basis.

Before starting the trial with WeReha, every patient enrolled will receive proper training from a person dedicated to the project (who will be referred to as the "dedicated figure") appointed by the hospital and financially supported by the sponsor of the study.


Eligibility criteria: Inclusion Criteria:

* Ages Eligible for Study: Over the age of 18
* Sexes Eligible for Study: All
* First-time ischemic or haemorrhagic stroke, as documented by a CT or MRI
* Patients able to sit for at least ten minutes and to look after own affairs without assistance i.e. a Modified Rankin Scale (MRS)≤ 2
* Montreal Cognitive Assessment (MoCA) ≥12
* Ability and willingness to participate in the study
* Signed consent form

Exclusion Criteria:

* Significant medical conditions that affected function prior to the stroke and would limit normal stroke rehabilitation (e.g. musculoskeletal condition affecting arm function or cardiac condition limiting basic activities of daily living).
* Bilateral weakness of upper extremities
* Unavailability of a caregiver
* Participation in another clinical trial involving rehabilitation (recreational therapy, occupational therapy, physiotherapy) or an investigational drug.

Primary outcomes:
measure: Total number of patients enrolled
timeFrame: Through study completion, an average of 1 year
measure: Total number of active patients
timeFrame: Through study completion, an average of 1 year
measure: Total number of patients who drop off
timeFrame: Through study completion, an average of 1 year
measure: Average number of active weeks for each patient
timeFrame: Through study completion, an average of 1 year
measure: Activity participation
timeFrame: Through study completion, an average of 1 year
measure: Questionnaire: Technology Acceptance Model (TAM)
timeFrame: Through treatment completion, an average of 3 months
Secondary outcomes:
measure: Barthel index
timeFrame: At the beginning of the treatment (baseline) and through treatment completion, an average of 3 months
measure: Disability Scale: Modified Rankin Score (mRS)
timeFrame: At the beginning of the treatment (baseline) and through treatment completion, an average of 3 months
measure: Training time
timeFrame: Through study completion, an average of 1 year
measure: Number of calls
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: D'Annunzio University of Chieti-Pescara
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Belfast
country: United Kingdom
facility: Ulster Hospital
Study officials:
References:
citation: Bellomo RG, Paolucci T, Saggino A, Pezzi L, Bramanti A, Cimino V, Tommasi M, Saggini R. The WeReha Project for an Innovative Home-Based Exercise Training in Chronic Stroke Patients: A Clinical Study. J Cent Nerv Syst Dis. 2020 Dec 13;12:1179573520979866. doi: 10.1177/1179573520979866. eCollection 2020.