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NCT Number: NCT07240948

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location contact

Cristina Guirao, OT Phy

SUB_INVESTIGATOR

Esther Sanchez-Gabilan, OT

SUB_INVESTIGATOR

Marian Muchada, MD PhD

SUB_INVESTIGATOR

Marta Rubiera, MD PhD

PRINCIPAL_INVESTIGATOR

Vall d'Hebron Institute of Research

CONTACT

[email protected]

0034 93 489 30 00

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adherence levels to prescribed rehabilitation protocols

    Time frame: At the end of the treatment period (12 weeks from baseline)

    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.

  2. Improvement in the self-perceived health status and quality of life

    Time frame: Baseline (before treatment initiation) and end-visit (after 12 weeks)

    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.

  3. User performance evaluation

    Time frame: After weeks 2 and 12 (end of study) from treatment initiation

    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.

Other outcomes

  1. Patient's satisfaction and usability evaluation

    Time frame: End of the treatment period (after 12 weeks)

    Test of patients' satisfaction and usability of the Muvity program will be performed through a Picker test-like PREM (patient-reported experience measurement) administered to patients in the interventional group

Study contacts

Contact information is provided by the study sponsor or research team.

Marián Muchada, MD PhD

CONTACT

[email protected]

0034 636803231

Marta Rubiera, MD PhD

CONTACT

[email protected]

0034 647390477

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Muvity
  • Nora Therapeutics, Inc.

Registry information

Official study title

Functional Improvement in Subacute/Chronic Stroke Patients Through a Non-invasive Virtual-reality Based Telerehabilitation Home System

Acronym: MUVITY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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