An interventional study of VR-based Telerehabilitation with Home Kit and Standard Rehabilitation (Conventional Care) in Ictus, Stroke and Parkinson Disease, sponsored by Azienda Usl di Bologna. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Azienda Usl di Bologna · Not applicable, Interventional, and Health services research
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:
Telerehabilitation (TR) is defined as the remote delivery of rehabilitation services through telecommunications technologies. It offers particular advantages for patients with neurological disabilities who require continuous and personalized rehabilitation training, enabling flexible treatment protocols and ongoing clinical-functional monitoring, especially for those residing in remote areas or with limited mobility.
Immersive virtual reality (VR) represents a highly engaging environment in which multiple forms of sensory feedback-auditory, visual, and tactile-can be organized to activate cortical and subcortical neural structures, thereby promoting functional and structural recovery. Evidence on neuroplasticity suggests that immersive VR systems may represent a key element in rehabilitation programs by enhancing motor learning capacity. Through specialized devices, it is possible to recreate and simulate actions in an immersive virtual environment, allowing patients to experience safe and realistic scenarios with real-time responses to stimuli, eliciting physiological and neural activation comparable to real-world experiences.
In patients with stroke sequelae or Parkinson's disease, the combination of TR and immersive VR-compared to conventional therapeutic approaches-allows for interactive, task-specific treatment adapted to individual patient characteristics, delivered over extended periods with adequate patient engagement. This approach may have a positive neuropsychological impact in terms of disability acceptance and usability, improving functional outcomes and quality of life.
The experimental treatment group will perform a personalized cognitive and/or motor rehabilitation protocol using a certified Home Kit including an immersive VR headset, already employed in clinical practice at the coordinating center. After three in-person sessions for technology familiarization, patients will use the Home Kit at home for 50 minutes per day, 5 days per week, asynchronously, with one weekly synchronous session via videoconferencing with the therapist. Continuous remote monitoring of outcomes and timely adjustment of parameters will be ensured throughout the 4-week treatment period.
The control group will receive cognitive and/or motor rehabilitation according to standard clinical practice (individual rehabilitation program, 50-minute sessions, 5 days per week for 4 weeks).
Randomization will be performed by an external collaborator not involved in patient assessment or treatment, using a pre-generated randomization list to ensure allocation concealment.
Patients will be assessed at baseline (T0), at the end of the 4-week treatment (T1), and at 3-month follow-up (T2) using standardized clinical scales evaluating balance, fall risk, walking ability, upper limb impairment, activities of daily living, memory and attention, and quality of life. Acceptability and usability of the VR telerehabilitation system will be assessed at T1 in the experimental group only.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Azienda Usl di Bologna is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive an individualized cognitive and/or motor rehabilitation protocol via a certified Home Kit inclusive of an immersive VR headset. After 3 in-person familiarization sessions, patients will perform the rehabilitation program at home for 50 minutes/day, 5 days/week, for 4 weeks, in asynchronous mode with one weekly synchronous videoconference session with the therapist. Continuous telemonitoring and parameter adaptation will be provided throughout the treatment period.
Other: VR-based Telerehabilitation with Home Kit
Patients will receive cognitive and/or motor rehabilitation according to standard clinical practice, consisting of individual rehabilitation sessions of 50 minutes, 5 days per week, for 4 weeks, as defined by the individual rehabilitation project.
Other: Standard Rehabilitation (Conventional Care)
The 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.
Patients 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.
Time frame: End of treatment (T1, Week 4)
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.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
6-Minute Walk Test (6-MWT)
Comparison of 6-MWT scores (distance in meters; higher score indicates better performance) between the groups and within the experimental group. 6-MWT assesses physical endurance and aerobic capacity by measuring the distance walked in 6 minutes.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Comparison of FMA-UE scores (range 0-126; higher score indicates better performance) between the groups and within the experimental group. FMA-UE evaluates upper limb motor function after neurological impairment.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Barthel Index (BI)
Comparison of BI scores (range 0-100; higher score indicates better performance) between the groups and within the experimental group. BI measures independence in basic activities of daily living.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Trail Making Test (TMT)
Comparison of TMT scores (time in seconds; higher score indicates worse performance) between the groups and within the experimental group. TMT assesses attention, processing speed, and cognitive flexibility.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
15-Word Memory Test (15-WMT)
Comparison of 15-WMT scores (range 0-75; higher score indicates better performance) between the groups and within the experimental group. 15-WMT measures verbal memory and learning ability.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Corsi Span Test (CS)
Comparison of CS scores (range 0-9; higher score indicates better performance) between the groups and within the experimental group. CS evaluates short-term visuospatial memory.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Digit Span Test (DS)
Comparison of DS scores (range 0-9; higher score indicates better performance) between the groups and within the experimental group. DS measures working memory and the ability to retain numerical sequences.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Short Form Health Survey-36 (SF-36)
Comparison of SF-36 scores (range 0-100; higher score indicates better performance) between the groups and within the experimental group. SF-36 assesses health-related quality of life in physical and mental domains.
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Patient satisfaction with the VR-based telerehabilitation system (CSQ-8)
Assessment of patient satisfaction using the Client Satisfaction Questionnaire (CSQ-8, Larsen et al., 1979; score range 8-32; higher scores indicate greater satisfaction). Administered to the experimental group only.
Time frame: Post-treatment (T1, Week 4)
Perceived usability of the VR-based telerehabilitation system (SUS)
Assessment of perceived usability using the System Usability Scale (SUS, Brooke, 1986; score range 0-100; higher scores indicate better usability). Administered to the experimental group only.
Time frame: Post-treatment (T1, Week 4)
Plan to share: No
Start is estimated for Jun 2026; primary completion for Jul 2026, 1 month later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 1 month is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Usl di Bologna