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

Official title

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

Overview

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.

Interventions

• Device 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 v

Primary outcome measures

• Median change in the Motor Fugl-Meyer and Berg Balance Scales [Time frame: From baseline to the end of treatment period (12 weeks)]

Secondary outcome measures (3)

• 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]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitari Vall d'Hebron — Barcelona

Identifiers

NCT: NCT07240948 · PS(AG)034/2025(6497) · PI23/01680

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗