Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation

NCT ID: NCT07240948

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-03-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MUVITY arm

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.

Group Type: EXPERIMENTAL

Non- immersive virtual reality (niVR)-based telerehabilitation home program

Intervention Type: DEVICE

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.

Control arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non- immersive virtual reality (niVR)-based telerehabilitation home program

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age >18 years-old
• Ischemic or hemorrhagic stroke within 3 to 12 months before inclusion
• Inclusion modified Rankin scale 1 to 3
• 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.

Exclusion Criteria

• 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).

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

Sponsors

Nora Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Muvity

UNKNOWN

Sponsor Role: collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Countries

Spain

Central Contacts

Marta Rubiera, MD PhD

Role: CONTACT

martaaurora.rubiera@vallhebron.cat

0034 647390477

Marián Muchada, MD PhD

Role: CONTACT

mangeles.muchada@vallhebron.cat

0034 636803231

Facility Contacts

Vall d'Hebron Institute of Research

Role: primary

comunica@vhir.org

0034 93 489 30 00

Role: backup

martaaurora.rubiera@vallhebron.cat

Related Links

https://muvity.cat/about.html

Muvity web-page

https://www.nora.bio/

Nora web-page

Other Identifiers

PI23/01680

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PS(AG)034/2025(6497)

Identifier Type: -

Identifier Source: org_study_id