Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
MUVITY
2 other identifiers
interventional
322
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2025
CompletedFirst Submitted
Initial submission to the registry
November 16, 2025
CompletedFirst Posted
Study publicly available on registry
November 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
November 21, 2025
November 1, 2025
1.3 years
November 16, 2025
November 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From baseline to the end of treatment period (12 weeks)
Secondary Outcomes (3)
Adherence levels to prescribed rehabilitation protocols
At the end of the treatment period (12 weeks from baseline)
Improvement in the self-perceived health status and quality of life
Baseline (before treatment initiation) and end-visit (after 12 weeks)
User performance evaluation
After weeks 2 and 12 (end of study) from treatment initiation
Other Outcomes (1)
Patient's satisfaction and usability evaluation
End of the treatment period (after 12 weeks)
Study Arms (2)
MUVITY arm
EXPERIMENTALUsers 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 INTERVENTIONConventional 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age \>18 years-old
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari Vall d'Hebron Research Institutelead
- Nora Therapeutics, Inc.collaborator
- Muvitycollaborator
Study Sites (1)
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2025
First Posted
November 21, 2025
Study Start
November 1, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The IPD will be available at the end of the clinical study (from February 2027) until February 2037
- Access Criteria
- Data will be shared through e-mail contact with the PI, upon reasonable request
All anonymized clinical, functional dynamic and kinematic individual patient data (IPD) together with identifying metadata (with exception of those related with Muvity intellectual property)