StrokeMUVITYNCT07240948
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
A study testing Non- immersive virtual reality (niVR)-based telerehabilitation home program in people with Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Stroke is the leading cause of disability in adults worldwide. Rehabilitation after a stroke is crucial, even after the acute phase: initially, it aims to recover the deficits caused by the stroke, but in the subacute/chronic phases the objective is to maintain the functional abilities already acquired. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Non- immersive virtual reality (niVR)-based telerehabilitation home program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age >18 years-old
- Ischemic or hemorrhagic stroke within 3 to 12 months before inclusion
- Motor rehabilitation requirements defined by the stroke neurologist/physiatrist in the out-patient clinic
- Bipedal standing: capable of keeping on two feet for two minutes without using hand supports.
Who cannot join
- Technological abilities: patient and caregiver do not manage smartphone and computer
- Severe aphasia/ language barrier with patient/caregiver that impairs communication
- Severe cognitive impairment (dementia) that affects short- and medium-term memory.
- End-of-life- or life-threatening pathology with an estimated survival <1 year.
- Receiving intense physical therapy (rehabilitation with at least one face-to-face physical treatment/week).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Vall d'Hebron Institute of Research, 0034 93 489 30 00, comunica@vhir.org
martaaurora.rubiera@vallhebron.cat
About this study
Official title: Functional Improvement in Subacute/Chronic Stroke Patients Through a Non-invasive Virtual-reality Based Telerehabilitation Home System
Stroke is the leading cause of disability in adults worldwide. Rehabilitation after a stroke is crucial, even after the acute phase: initially, it aims to recover the deficits caused by the stroke, but in the subacute/chronic phases the objective is to maintain the functional abilities already acquired. After the acute phase, traditional rehabilitation methods usually include exercises prescribed by a therapist that the patient performs on their own. However, their effectiveness is limited due to the lack of supervision, adherence, and insufficient information provided to the patient about their progress, which would require regular in-person contact with the patient. To date, public health systems have been unable to provide this kind of access to rehabilitation for post-stroke patients, with the risk of worsening deficits and a decline in quality of life. We plan to develop an individualized home-based monitoring program enhanced by telerehabilitation based on non-immersive virtual reality (without the need for VR goggles or other "gadgets") (MUVITY) for patients who suffered a stroke in the subacute/chronic phase.
Patients seen during an outpatient consultation who require rehabilitation will be randomly assigned either the usual treatment (they will receive a document describing the exercises to perform and a suggested schedule, togheter with an app for communication and health-education, Nora) or the MUVITY treatment: patients will be provided with the telerehabilitation system using a computer and camera where they will perform the rehabilitation exercises, which will be individually adapted according to their progress by a physiotherapist, together with Nora. We believe that MUVITY will lead to improved motor function, emotional well-being, and quality of life, increasing adherence to rehabilitation treatment compared with usual care, and that it can be used in terms of patient satisfaction and pain levels.
Our findings could confirm that telerehabilitation improves motor function and quality of life after stroke. Furthermore, since it is a home-based system, its use would considerably increase the number of patients who can receive treatment compared with in-person therapies, eliminating geographic barriers related to distance from rehabilitation centers and offering cost-effective access to effective treatment for all patients. Additionally, our system allows continuous interaction between patients and healthcare professionals, and provides information about their progress, which helps reduce stress related to uncertainty about the future and supports key aspects of monitoring patients in the subacute/chronic phase of stroke such as risk factor control and early detection of complications.
- Conditions
- Stroke
- Being tested
- Non- immersive virtual reality (niVR)-based telerehabilitation home program
- Keywords
- Stroke rehabilitation, chronic stroke rehabilitation, tele-rehabilitation, telestroke, telehealth, home rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non- immersive virtual reality (niVR)-based telerehabilitation home programDevice
Muvity (software of non-immersive virtual reality (niVR) through a depth camera installed in a personal computer (PC)) will be provided with a personalized treatment plan to be carried out 3times/week along 12w in the patient's home. The user will see exercises and serious games as daily quests, in a gamified environment with alerts to remind the scheduled treatment. The potential exercises include following a virtual avatar to perform individual movements (shoulder flexion-extension, shoulder vertical or horizontal abduction-adduction, elbow flexion-extension, hip flexion-extension or hip abduction-adduction), squats or medio-lateral movements of the pelvis to control the body weight transfer. The serious games are oriented toward performing movements in activities of daily living, such as cooking, cleaning a mirror, or acting as a goalkeeper, or collecting apples.
| Study group | Role | What they receive |
|---|---|---|
| MUVITY arm | Experimental | Users of the Muvity telerehabilitation system. At baseline, a therapist will elaborate a personalized treatment plan consisting of exercises and games to be carried out during 12 weeks in the patient's home. Muvity will be provided to each participant for the duration of the program (software of non-immersive virtual reality (niVR) through a depth camera installed in a personal computer (PC)). The user will see the exercises and serious games in the loaned PC as daily quests, in a gamified environment, to be completed in 30 min, three times per week. Alerts will be sent through Nora to remind the scheduled treatment, and a contact from the case-manager will be performed if the patient does not perform treatment. Questions about pain feeling perception and emotional wellbeing will be asked before and after each session automatically by the system and the patient will be able to contact the case manager/physiotherapist for questions/comments, and to receive feedback. Receives: Device: Non- immersive virtual reality (niVR)-based telerehabilitation home program |
| Control arm | No intervention | Conventional at-home rehabilitation treatment and routine follow-up. The participant will receive an informative sheet with the description of the exercises prescribed by the physiatrist and elaborated by the physiotherapist, with the instructions to perform sessions of 30 min three times a week. The exercises will cover similar movements as the ones formulated in the telerehabilitation system for the intervention group. In the Nora app, the patient in the control group will need to actively report the timing of his/her rehabilitation treatment, and the same questions about pain feeling perception and emotional wellbeing before and after each treatment. However, no feedback of rehabilitation progress will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median change in the Motor Fugl-Meyer and Berg Balance Scales
Description: Comparison of the median change between treatment arms in the Fugl-Meyer and Berg Balance Scales evaluated before and after treatment. The measurement will be performed in the first visit to establish a baseline in both Muvity and control arms. At the end of the treatment, a face-to-face visit by a researcher (trained occupational therapist) blinded to the treatment group will be performed, and a new evaluation of the scales will be performed. The outcome will be evaluated by the Mann-Whitney U test and Rank Transformation ANCOVA.
Measured: From baseline to the end of treatment period (12 weeks)
Secondary outcomes (3)
Adherence levels to prescribed rehabilitation protocols
Comparison of the adherence to the prescribed rehabilitation protocols in both the Muvity and control arms. For the evaluation, automatic system data will be collected in the Muvity software for the intervention group (descriptive, no comparison). To compare the adherence between arms, a specific questionnaire has been developed and will be administered to all patients. In addition, patients in the control group will be able to register their rehabilitation sessions in a new functionality created in the Nora app.
Measured: At the end of the treatment period (12 weeks from baseline)
Improvement in the self-perceived health status and quality of life
Comparison of the self-perceived health status and quality of life, together with pain perception during the rehabilitation treatment, in both the Muvity and control arms. In both arms, evaluation will be performed by the HRQoL(Health-Related Quality of Life), PROMIS-10 (Patient-Reported Outcomes Measurement Information System 10-Item), HADs (Hospital Anxiety and Depression Scale) and Pain-VAS (Visual Analog Scale) patient-reported outcome measurements. A baseline evaluation will be performed before treatment initiation, and a second one at the end of the treatment period. A comparison of the median scores in the different groups at the end of the study, adjusted by baseline, and a comparison of the change in the scores of each individual patient will be performed. The outcome will be evaluated by the Mann-Whitney U test and Rank Transformation ANCOVA.
Measured: Baseline (before treatment initiation) and end-visit (after 12 weeks)
User performance evaluation
Tracking of user performance progression through in-game metrics (e.g., level scores, duration at week 2 and 12 of treatment) in the Muvity treatment arm.
Measured: After weeks 2 and 12 (end of study) from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open trial with blind evaluation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Nora Therapeutics, Inc., Muvity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240948
- Sponsor's protocol ID
- PS(AG)034/2025(6497)
- Other IDs
- PI23/01680
- Acronym
- MUVITY
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized clinical, functional dynamic and kinematic individual patient data (IPD) together with identifying metadata (with exception of those related with Muvity intellectual property)
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Improvement in Subacute/Chronic Stroke Patients Through a Non-invasive Virtual-reality Based Telerehabilitation Home System
- ClinicalTrials.gov ID
- NCT07240948
- Acronym / sponsor ID
- MUVITY / PS(AG)034/2025(6497)
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, chronic stroke rehabilitation, tele-rehabilitation, telestroke, telehealth, home rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Nora Therapeutics, Inc., Muvity
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Nov 2025 (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.
Stroke is the leading cause of disability in adults worldwide. Rehabilitation after a stroke is crucial, even after the acute phase: initially, it aims to recover the deficits caused by the stroke, but in the subacute/chronic phases the objective is to maintain the functional abilities already acquired. After the acute phase, traditional rehabilitation methods usually include exercises prescribed by a therapist that the patient performs on their own. However, their effectiveness is limited due to the lack of supervision, adherence, and insufficient information provided to the patient about their progress, which would require regular in-person contact with the patient. To date, public health systems have been unable to provide this kind of access to rehabilitation for post-stroke patients, with the risk of worsening deficits and a decline in quality of life. We plan to develop an individualized home-based monitoring program enhanced by telerehabilitation based on non-immersive virtual reality (without the need for VR goggles or other "gadgets") (MUVITY) for patients who suffered a stroke in the subacute/chronic phase.
Patients seen during an outpatient consultation who require rehabilitation will be randomly assigned either the usual treatment (they will receive a document describing the exercises to perform and a suggested schedule, togheter with an app for communication and health-education, Nora) or the MUVITY treatment: patients will be provided with the telerehabilitation system using a computer and camera where they will perform the rehabilitation exercises, which will be individually adapted according to their progress by a physiotherapist, together with Nora. We believe that MUVITY will lead to improved motor function, emotional well-being, and quality of life, increasing adherence to rehabilitation treatment compared with usual care, and that it can be used in terms of patient satisfaction and pain levels.
Our findings could confirm that telerehabilitation improves motor function and quality of life after stroke. Furthermore, since it is a home-based system, its use would considerably increase the number of patients who can receive treatment compared with in-person therapies, eliminating geographic barriers related to distance from rehabilitation centers and offering cost-effective access to effective treatment for all patients. Additionally, our system allows continuous interaction between patients and healthcare professionals, and provides information about their progress, which helps reduce stress related to uncertainty about the future and supports key aspects of monitoring patients in the subacute/chronic phase of stroke such as risk factor control and early detection of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, open trial with blind evaluation
| Arm | Type | Receives |
|---|---|---|
| MUVITY arm | Experimental | Device: Non- immersive virtual reality (niVR)-based telerehabilitation home programUsers of the Muvity telerehabilitation system. At baseline, a therapist will elaborate a personalized treatment plan consisting of exercises and games to be carried out during 12 weeks in the patient's home. Muvity will be provided to each participant for the duration of the program (software of non-immersive virtual reality (niVR) through a depth camera installed in a personal computer (PC)). The user will see the exercises and serious games in the loaned PC as daily quests, in a gamified environment, to be completed in 30 min, three times per week. Alerts will be sent through Nora to remind the scheduled treatment, and a contact from the case-manager will be performed if the patient does not perform treatment. Questions about pain feeling perception and emotional wellbeing will be asked before and after each session automatically by the system and the patient will be able to contact the case manager/physiotherapist for questions/comments, and to receive feedback. |
| Control arm | No intervention | –Conventional at-home rehabilitation treatment and routine follow-up. The participant will receive an informative sheet with the description of the exercises prescribed by the physiatrist and elaborated by the physiotherapist, with the instructions to perform sessions of 30 min three times a week. The exercises will cover similar movements as the ones formulated in the telerehabilitation system for the intervention group. In the Nora app, the patient in the control group will need to actively report the timing of his/her rehabilitation treatment, and the same questions about pain feeling perception and emotional wellbeing before and after each treatment. However, no feedback of rehabilitation progress will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years-old
- Ischemic or hemorrhagic stroke within 3 to 12 months before inclusion
- Motor rehabilitation requirements defined by the stroke neurologist/physiatrist in the out-patient clinic
- Bipedal standing: capable of keeping on two feet for two minutes without using hand supports.
Key exclusion criteria (5 listed)
- Technological abilities: patient and caregiver do not manage smartphone and computer
- Severe aphasia/ language barrier with patient/caregiver that impairs communication
- Severe cognitive impairment (dementia) that affects short- and medium-term memory.
- End-of-life- or life-threatening pathology with an estimated survival <1 year.
- Receiving intense physical therapy (rehabilitation with at least one face-to-face physical treatment/week).
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 |
|---|---|---|
| Non- immersive virtual reality (niVR)-based telerehabilitation home programMuvity (software of non-immersive virtual reality (niVR) through a depth camera installed in a personal computer (PC)) will be provided with a personalized treatment plan to be carried out 3times/week along 12w in the patient's home. The user will see exercises and serious games as daily quests, in a gamified environment with alerts to remind the scheduled treatment. The potential exercises include following a virtual avatar to perform individual movements (shoulder flexion-extension, shoulder vertical or horizontal abduction-adduction, elbow flexion-extension, hip flexion-extension or hip abduction-adduction), squats or medio-lateral movements of the pelvis to control the body weight transfer. The serious games are oriented toward performing movements in activities of daily living, such as cooking, cleaning a mirror, or acting as a goalkeeper, or collecting apples. | Device | MUVITY arm |
Primary outcome
Median change in the Motor Fugl-Meyer and Berg Balance Scales
Time frame: From baseline to the end of treatment period (12 weeks)
Description: Comparison of the median change between treatment arms in the Fugl-Meyer and Berg Balance Scales evaluated before and after treatment. The measurement will be performed in the first visit to establish a baseline in both Muvity and control arms. At the end of the treatment, a face-to-face visit by a researcher (trained occupational therapist) blinded to the treatment group will be performed, and a new evaluation of the scales will be performed. The outcome will be evaluated by the Mann-Whitney U test and Rank Transformation ANCOVA.
3 secondary outcomes
Adherence levels to prescribed rehabilitation protocols
Time frame: At the end of the treatment period (12 weeks from baseline)
Improvement in the self-perceived health status and quality of life
Time frame: Baseline (before treatment initiation) and end-visit (after 12 weeks)
User performance evaluation
Time frame: After weeks 2 and 12 (end of study) from treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Muvity web-pageLink provided by the sponsor.
- Nora web-pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All anonymized clinical, functional dynamic and kinematic individual patient data (IPD) together with identifying metadata (with exception of those related with Muvity intellectual property)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non- immersive virtual reality (niVR)-based telerehabilitation home program in people with Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Rubiera, MD PhD (0034 647390477, martaaurora.rubiera@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median change in the Motor Fugl-Meyer and Berg Balance Scales (time frame: From baseline to the end of treatment period (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.