Stroke Home Rehabilitation With WeReha

Stroke Clinical Trial

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Official title:

A New Solution for Home Rehabilitation of Stroke Patients: WeReha

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03964662
• Other study ID #: WeReha
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: February 2019
• Source: CoRehab s.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• WeReha
Rehabilitation of stroke patients with the device WeReha

Locations

Country	Name	City	State
Italy	D'Annunzio University of Chieti-Pescara	Chieti
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Ulster Hospital	Belfast

Sponsors (3)

Lead Sponsor	Collaborator
CoRehab s.r.l.	Engineering Ingegneria Informatica SpA, Fondazione Bruno Kessler

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 1 year
Primary	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	Through study completion, an average of 1 year
Primary	Total number of patients who drop off		Through study completion, an average of 1 year
Primary	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	Through study completion, an average of 1 year
Primary	Activity participation	Average of minutes per day dedicated to exercises with WeReha	Through study completion, an average of 1 year
Primary	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: Perceived Ease of Use (maximal score 49, minimum score 7); Perceived Usefulness (maximal score 42, minimum score 6); Attitude Toward Using (maximal score 35, minimum score 5); 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.	Through treatment completion, an average of 3 months
Secondary	Barthel index		At the beginning of the treatment (baseline) and through treatment completion, an average of 3 months
Secondary	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	At the beginning of the treatment (baseline) and through treatment completion, an average of 3 months
Secondary	Training time	Time dedicated by the specialised personnel to each patient for training to learn the WeReha device before leaving the trial site	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year