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

Vall d'Hebron University Hospital (HUVH)

Status: Not yet enrolling

Conditions: Stroke

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07240948

PS(AG)034/2025(6497)

PI23/01680 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 322 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

322 participants in 2 patient groups

MUVITY arm

Experimental group

Description:

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.

Treatment:

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

Control arm

No Intervention group

Description:

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.