The goal of this interventional pilot trial is to evaluate whether a telerehabilitation protocol based on immersive virtual reality (VR) is effective and feasible for the recovery of cognitive and/or motor functions in patients with sequelae of ischemic or hemorrhagic stroke or with Parkinson's disease.
The main questions it aims to answer are:
* Does the VR-based telerehabilitation protocol improve cognitive and/or motor outcomes compared to conventional rehabilitation? * Is the protocol feasible, defined as ≥80% adherence among participants? Is the system acceptable and user-friendly from the patient's perspective? Researchers will compare an interventional arm receiving telerehabilitation via an immersive VR home kit with a control arm receiving conventional rehabilitation according to standard clinical practice. Both groups will receive the same number of sessions, with the same duration and weekly frequency. Outcomes will be assessed at baseline (T0), after 4 weeks of treatment (T1), and at 3-month follow-up (T2).
Age >18 years old, both sex;
stroke or Parkinson diagnosis > or = 2 months;
upper limb impairment
informed consent signed
ongoing clinical instability;
important cognitive impairment;
psychiatric, neurological, or internal medicine comorbidities;
severe rigidity or hypertonia;
Parallel
VR-based Telerehabilitation with Home Kit
Other interventionThe proposed intervention uses a certified Home Kit - inclusive of an immersive VR headset - already employed in clinical practice at the coordinating center (IRCCS ISNB, Bologna). The rehabilitation team (physician, speech therapist, physiotherapist) defines an individualized protocol for cognitive and/or motor recovery. The first 3 sessions are conducted in-person to allow technology familiarization. Patients then use the Home Kit at home for 50 minutes/day, 5 days/week, for 4 weeks, in asynchronous mode. One weekly synchronous session via videoconference with the therapist is included. The Home Kit automatically records daily protocol execution, enabling continuous telemonitoring and timely adaptation of rehabilitation parameters.
Standard Rehabilitation (Conventional Care)
Other interventionPatients in the control group receive cognitive and/or motor rehabilitation according to standard clinical practice, as defined by the individual rehabilitation project. Sessions last 50 minutes, are delivered 5 days per week, for 4 weeks, and are conducted in person at the rehabilitation unit. No virtual reality or telerehabilitation technology is used in this arm.
Adherence rate to the telerehabilitation protocol
Feasibility is defined as the proportion of participants in the TR group achieving ≥80% adherence to the prescribed daily rehabilitation sessions over the 4-week protocol. A participant is considered adherent if they complete at least 80% of scheduled sessions and both pre- and post-treatment assessments. Adherence is automatically recorded by the Home Kit device.
Berg Balance Scale (BBS)
Comparison of BBS scores (range 0-56; higher score indicates better performance) between the groups and within the experimental group. BBS assesses static and dynamic balance during functional daily activities and movements.
Timed Up and Go Test (TUG)
Comparison of TUG scores (time in seconds; higher score indicates worse performance) between the groups and within the experimental group. TUG measures functional mobility and fall risk by timing standing up, walking, turning, and sitting down.
Falls Efficacy Scale (FES)
Comparison of FES scores (range 16-64; higher score indicates worse performance) between the groups and within the experimental group. FES evaluates fear of falling during activities of daily living.
10-Meter Walk Test (10-MWT)
Comparison of 10-MWT scores (time in seconds; higher score indicates worse performance) between the groups and within the experimental group. 10-MWT measures walking speed over a distance of 10 meters.
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