Stroke, AcuteWRNCT03964662
Stroke Home Rehabilitation With WeReha
A study testing WeReha in people with Stroke, Acute and Stroke, run by CoRehab s.r.l. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Stroke
- What is being tested?
- WeReha
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Dec 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Royal Victoria Hospital
Belfast, BT12 6BA
Ulster Hospital
Belfast, BT16 1RH
About this study
Official title: A New Solution for Home Rehabilitation of Stroke Patients: WeReha
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:
Read more
- 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
- Being tested
- WeReha
- Keywords
- home rehabilitation, technology, stroke, biofeedback, games
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeRehaDevice
Rehabilitation of stroke patients with the device WeReha
| Study group | Role | What they receive |
|---|---|---|
| Patients with stroke | Experimental | Rehabilitation of patients with stroke using a new technological device: WeReha Receives: Device: WeReha |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, an average of 1 year
Total number of patients who drop off
Measured: 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
Measured: Through study completion, an average of 1 year
Activity participation
Average of minutes per day dedicated to exercises with WeReha
Measured: 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:
- 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.
Measured: Through treatment completion, an average of 3 months
Secondary outcomes (4)
Barthel index
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start18 Dec 2018
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoRehab s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Engineering Ingegneria Informatica SpA, Fondazione Bruno Kessler
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964662
- Sponsor's protocol ID
- WeReha
- Acronym
- WR
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33402861
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Solution for Home Rehabilitation of Stroke Patients: WeReha
- ClinicalTrials.gov ID
- NCT03964662
- Acronym / sponsor ID
- WR / WeReha
- Conditions
- Stroke, Acute, Stroke
- Keywords
- home rehabilitation, technology, stroke, biofeedback, games
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- CoRehab s.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Engineering Ingegneria Informatica SpA, Fondazione Bruno Kessler
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke | Experimental | Device: WeRehaRehabilitation of patients with stroke using a new technological device: WeReha |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeRehaRehabilitation of stroke patients with the device WeReha | Device | Patients with stroke |
Primary outcome
Total number of patients enrolled
Time frame: Through study completion, an average of 1 year
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
Total number of active patients
Time frame: Through study completion, an average of 1 year
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
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
Time frame: Through study completion, an average of 1 year
: the average number of active weeks is evaluated as the total number of active weeks divided by the number of patients enrolled
Activity participation
Time frame: Through study completion, an average of 1 year
Average of minutes per day dedicated to exercises with WeReha
Questionnaire: Technology Acceptance Model (TAM)
Time frame: Through treatment completion, an average of 3 months
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.
4 secondary outcomes
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)
Time frame: At the beginning of the treatment (baseline) and through treatment completion, an average of 3 months
Training time
Time frame: Through study completion, an average of 1 year
Number of calls
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 33402861Bellomo 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.
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeReha in people with Stroke, Acute and Stroke, run by CoRehab s.r.l. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of patients enrolled (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.