An interventional study of WeReha in Stroke, Acute and Stroke, sponsored by CoRehab s.r.l.. Status unknown at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by CoRehab s.r.l. · Not applicable, Interventional, and Treatment
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:
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with CoRehab s.r.l. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rehabilitation of patients with stroke using a new technological device: WeReha
Device: WeReha
Rehabilitation of stroke patients with the device WeReha
Total number of patients enrolled
A patient is considered enrolled in the study if they are within the inclusion criteria and voluntarily accept to participate and sign the consent form
Time frame: Through study completion, an average of 1 year
Total number of active patients
A patient that has used the device for at least 4 "active weeks". An "active week" is a week in which the patient has performed at least three sessions with WeReha for a minimum of 15 minutes each
Time frame: Through study completion, an average of 1 year
Total number of patients who drop off
Time frame: Through study completion, an average of 1 year
Average number of active weeks for each patient
: the average number of active weeks is evaluated as the total number of active weeks divided by the number of patients enrolled
Time frame: Through study completion, an average of 1 year
Activity participation
Average of minutes per day dedicated to exercises with WeReha
Time frame: Through study completion, an average of 1 year
Questionnaire: Technology Acceptance Model (TAM)
The Technology Acceptance Model is a questionnaire that evaluate the acceptance of the rehabilitation platform WeReha by the patients. The TAM questionnaire comprises 22 items (divided into 4 area) each rated in a 7-point Likert-scale, whereby a score of 1 refers to "I do not agree at all" and a score of 7 refers to "I agree entirely". The 4 area are: 1. Perceived Ease of Use (maximal score 49, minimum score 7) 2. Perceived Usefulness (maximal score 42, minimum score 6) 3. Attitude Toward Using (maximal score 35, minimum score 5) 4. Behavioral Intention to Use (maximal score 28, minimum score 4). The scores achived in the different area are summed to have a total score.The total maximum score, corresponding to 154, indicates a complete acceptance of the use of a technology device, such as WeReha, for the rehabilitation process; the minimum score, corresponding to 22, indicates a tendency to refuse technology for the rehabilitation process.
Time frame: Through treatment completion, an average of 3 months
Barthel index
Time frame: At the beginning of the treatment (baseline) and through treatment completion, an average of 3 months
Disability Scale: Modified Rankin Score (mRS)
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials
Time frame: At the beginning of the treatment (baseline) and through treatment completion, an average of 3 months
Training time
Time dedicated by the specialised personnel to each patient for training to learn the WeReha device before leaving the trial site
Time frame: Through study completion, an average of 1 year
Number of calls
Number of calls per week for clinical and technical assistance specific for the WeReha device, registered on a paper or software spreadsheet by the sponsor
Time frame: Through study completion, an average of 1 year
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