IctusHOME VR REHABNCT07582497
Motor and Cognitive Telerehabilitation in a Virtual Environment in Patients With Post-stroke Sequelae and Parkinson's Disease
A study testing VR-based Telerehabilitation with Home Kit and Standard Rehabilitation (Conventional Care) in people with Ictus and Stroke, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ictus, Stroke, Parkinson Disease
- What is being tested?
- VR-based Telerehabilitation with Home Kit and Standard Rehabilitation (Conventional Care)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old, both sex;
- stroke or Parkinson diagnosis > or = 2 months;
- upper limb impairment
- informed consent signed
Who cannot join
- ongoing clinical instability;
- important cognitive impairment;
- psychiatric, neurological, or internal medicine comorbidities;
- severe rigidity or hypertonia;
- severe visual deficit;
- pregnancy women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, BO, 40193
Giada Lullini, +393394958751, giada.lullini@isnb.it
About this study
Official title: Telerehabilitation in a Virtual Environment for Sensorimotor and Cognitive Recovery in Patients With Post-stroke Sequelae and Parkinson's Disease: a Pilot Study
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).
Read the detailed description
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.
- Conditions
- Ictus, Stroke, Parkinson Disease
- Being tested
- VR-based Telerehabilitation with Home Kit, Standard Rehabilitation (Conventional Care)
- Keywords
- upper limb impairment, teleneurorehabilitation, virtual reality, telerehabilitation
- Medical subject headings
- Stroke, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based Telerehabilitation with Home KitOther
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.
Standard Rehabilitation (Conventional Care)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation with Immersive Virtual Reality (TR Group) | Experimental | 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. Receives: Other: VR-based Telerehabilitation with Home Kit |
| Conventional Rehabilitation (Control Group) | Active comparator | 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. Receives: Other: Standard Rehabilitation (Conventional Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatment (T1, Week 4)
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-treatment (T1, Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for IctusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582497
- Sponsor's protocol ID
- HOMEVIRTUAL REHAB
- Acronym
- HOME VR REHAB
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marin-Medina DS, Arenas-Vargas PA, Arias-Botero JC, Gomez-Vasquez M, Jaramillo-Lopez MF, Gaspar-Toro JM. New approaches to recovery after stroke. Neurol Sci. 2024 Jan;45(1):55-63. doi: 10.1007/s10072-023-07012-3. Epub 2023 Sep 11.
PubMed 37697027Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455.
PubMed 31165721Kwon SH, Park JK, Koh YH. A systematic review and meta-analysis on the effect of virtual reality-based rehabilitation for people with Parkinson's disease. J Neuroeng Rehabil. 2023 Jul 20;20(1):94. doi: 10.1186/s12984-023-01219-3.
PubMed 37475014Cano Porras D, Siemonsma P, Inzelberg R, Zeilig G, Plotnik M. Advantages of virtual reality in the rehabilitation of balance and gait: Systematic review. Neurology. 2018 May 29;90(22):1017-1025. doi: 10.1212/WNL.0000000000005603. Epub 2018 May 2.
PubMed 29720544Alashram AR, Annino G, Padua E, Romagnoli C, Mercuri NB. Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. J Clin Neurosci. 2019 Aug;66:209-219. doi: 10.1016/j.jocn.2019.04.026. Epub 2019 May 10.
PubMed 31085075Aida J, Chau B, Dunn J. Immersive virtual reality in traumatic brain injury rehabilitation: A literature review. NeuroRehabilitation. 2018;42(4):441-448. doi: 10.3233/NRE-172361.
PubMed 29660958Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016.
PubMed 27124611De Luca R, Maggio MG, Naro A, Portaro S, Cannavo A, Calabro RS. Can patients with severe traumatic brain injury be trained with cognitive telerehabilitation? An inpatient feasibility and usability study. J Clin Neurosci. 2020 Sep;79:246-250. doi: 10.1016/j.jocn.2020.07.063. Epub 2020 Aug 17.
PubMed 33070905Ownsworth T, Arnautovska U, Beadle E, Shum DHK, Moyle W. Efficacy of Telerehabilitation for Adults With Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2018 Jul/Aug;33(4):E33-E46. doi: 10.1097/HTR.0000000000000350.
PubMed 29084100Maggio MG, Latella D, Maresca G, Sciarrone F, Manuli A, Naro A, De Luca R, Calabro RS. Virtual Reality and Cognitive Rehabilitation in People With Stroke: An Overview. J Neurosci Nurs. 2019 Apr;51(2):101-105. doi: 10.1097/JNN.0000000000000423.
PubMed 30649091Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
PubMed 29156493Luque-Moreno C, Ferragut-Garcias A, Rodriguez-Blanco C, Heredia-Rizo AM, Oliva-Pascual-Vaca J, Kiper P, Oliva-Pascual-Vaca A. A Decade of Progress Using Virtual Reality for Poststroke Lower Extremity Rehabilitation: Systematic Review of the Intervention Methods. Biomed Res Int. 2015;2015:342529. doi: 10.1155/2015/342529. Epub 2015 Oct 11.
PubMed 26539480Maresca G, Maggio MG, De Luca R, Manuli A, Tonin P, Pignolo L, Calabro RS. Tele-Neuro-Rehabilitation in Italy: State of the Art and Future Perspectives. Front Neurol. 2020 Sep 30;11:563375. doi: 10.3389/fneur.2020.563375. eCollection 2020.
PubMed 33101176Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015 Jun;21(4):202-13. doi: 10.1177/1357633X15572201. Epub 2015 Feb 22.
PubMed 25712109Wootton R, Bahaadinbeigy K, Hailey D. Estimating travel reduction associated with the use of telemedicine by patients and healthcare professionals: proposal for quantitative synthesis in a systematic review. BMC Health Serv Res. 2011 Aug 8;11:185. doi: 10.1186/1472-6963-11-185.
PubMed 21824388
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation in a Virtual Environment for Sensorimotor and Cognitive Recovery in Patients With Post-stroke Sequelae and Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT07582497
- Acronym / sponsor ID
- HOME VR REHAB / HOMEVIRTUAL REHAB
- Conditions
- Ictus, Stroke, Parkinson Disease
- Keywords
- upper limb impairment, teleneurorehabilitation, virtual reality, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation with Immersive Virtual Reality (TR Group) | Experimental | Other: VR-based Telerehabilitation with Home KitPatients 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. |
| Conventional Rehabilitation (Control Group) | Active comparator | Other: Standard Rehabilitation (Conventional Care)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years old, both sex;
- stroke or Parkinson diagnosis > or = 2 months;
- upper limb impairment
- informed consent signed
Key exclusion criteria (6 listed)
- ongoing clinical instability;
- important cognitive impairment;
- psychiatric, neurological, or internal medicine comorbidities;
- severe rigidity or hypertonia;
- severe visual deficit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-based Telerehabilitation with Home KitThe 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. | Other | Telerehabilitation with Immersive Virtual Reality (TR Group) |
| Standard Rehabilitation (Conventional Care)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. | Other | Conventional Rehabilitation (Control Group) |
Primary outcome
Adherence rate to the telerehabilitation protocol
Time frame: End of treatment (T1, Week 4)
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.
14 secondary outcomes
Berg Balance Scale (BBS)
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)
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Falls Efficacy Scale (FES)
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)
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)
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)
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Barthel Index (BI)
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Trail Making Test (TMT)
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)
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Corsi Span Test (CS)
Time frame: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Digit Span Test (DS)
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)
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)
Time frame: Post-treatment (T1, Week 4)
Perceived usability of the VR-based telerehabilitation system (SUS)
Time frame: Post-treatment (T1, Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 37697027Marin-Medina DS, Arenas-Vargas PA, Arias-Botero JC, Gomez-Vasquez M, Jaramillo-Lopez MF, Gaspar-Toro JM. New approaches to recovery after stroke. Neurol Sci. 2024 Jan;45(1):55-63. doi: 10.1007/s10072-023-07012-3. Epub 2023 Sep 11.
- Background: PubMed 31165721Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455.
- Background: PubMed 37475014Kwon SH, Park JK, Koh YH. A systematic review and meta-analysis on the effect of virtual reality-based rehabilitation for people with Parkinson's disease. J Neuroeng Rehabil. 2023 Jul 20;20(1):94. doi: 10.1186/s12984-023-01219-3.
- Background: PubMed 29720544Cano Porras D, Siemonsma P, Inzelberg R, Zeilig G, Plotnik M. Advantages of virtual reality in the rehabilitation of balance and gait: Systematic review. Neurology. 2018 May 29;90(22):1017-1025. doi: 10.1212/WNL.0000000000005603. Epub 2018 May 2.
- Background: PubMed 31085075Alashram AR, Annino G, Padua E, Romagnoli C, Mercuri NB. Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. J Clin Neurosci. 2019 Aug;66:209-219. doi: 10.1016/j.jocn.2019.04.026. Epub 2019 May 10.
- Background: PubMed 29660958Aida J, Chau B, Dunn J. Immersive virtual reality in traumatic brain injury rehabilitation: A literature review. NeuroRehabilitation. 2018;42(4):441-448. doi: 10.3233/NRE-172361.
- Background: PubMed 27124611Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016.
- Background: PubMed 33070905De Luca R, Maggio MG, Naro A, Portaro S, Cannavo A, Calabro RS. Can patients with severe traumatic brain injury be trained with cognitive telerehabilitation? An inpatient feasibility and usability study. J Clin Neurosci. 2020 Sep;79:246-250. doi: 10.1016/j.jocn.2020.07.063. Epub 2020 Aug 17.
- Background: PubMed 29084100Ownsworth T, Arnautovska U, Beadle E, Shum DHK, Moyle W. Efficacy of Telerehabilitation for Adults With Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2018 Jul/Aug;33(4):E33-E46. doi: 10.1097/HTR.0000000000000350.
- Background: PubMed 30649091Maggio MG, Latella D, Maresca G, Sciarrone F, Manuli A, Naro A, De Luca R, Calabro RS. Virtual Reality and Cognitive Rehabilitation in People With Stroke: An Overview. J Neurosci Nurs. 2019 Apr;51(2):101-105. doi: 10.1097/JNN.0000000000000423.
- Background: PubMed 29156493Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
- Background: PubMed 26539480Luque-Moreno C, Ferragut-Garcias A, Rodriguez-Blanco C, Heredia-Rizo AM, Oliva-Pascual-Vaca J, Kiper P, Oliva-Pascual-Vaca A. A Decade of Progress Using Virtual Reality for Poststroke Lower Extremity Rehabilitation: Systematic Review of the Intervention Methods. Biomed Res Int. 2015;2015:342529. doi: 10.1155/2015/342529. Epub 2015 Oct 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based Telerehabilitation with Home Kit and Standard Rehabilitation (Conventional Care) in people with Ictus and Stroke, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giada Lullini (+393394958751, giada.lullini@isnb.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate to the telerehabilitation protocol (time frame: End of treatment (T1, Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07582497, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.