Stroke Home Rehabilitation With WeReha

NCT ID: NCT03964662

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-18
• Study Completion Date: 2020-02-28

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.

Conditions

Stroke, Acute; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with stroke

Rehabilitation of patients with stroke using a new technological device: WeReha

Group Type: EXPERIMENTAL

WeReha

Intervention Type: DEVICE

Rehabilitation of stroke patients with the device WeReha

Interventions

WeReha

Rehabilitation of stroke patients with the device WeReha

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Engineering Ingegneria Informatica SpA

UNKNOWN

Sponsor Role: collaborator

Fondazione Bruno Kessler

OTHER

Sponsor Role: collaborator

CoRehab s.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

D'Annunzio University of Chieti-Pescara

Chieti, , Italy

Royal Victoria Hospital

Belfast, , United Kingdom

Ulster Hospital

Belfast, , United Kingdom

Countries

Italy; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33402861 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WeReha

Identifier Type: -

Identifier Source: org_study_id