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Motor and Cognitive Telerehabilitation in a Virtual Environment in Patients With Post-stroke Sequelae and Parkinson's Disease (HOME VR REHAB)

12. května 2026 aktualizováno: Azienda Usl di Bologna

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).

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • BO
      • Bologna, BO, Itálie, 40193
        • IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age >18 years old, both sex;
  • stroke or Parkinson diagnosis > or = 2 months;
  • upper limb impairment
  • informed consent signed

Exclusion Criteria:

  • ongoing clinical instability;
  • important cognitive impairment;
  • psychiatric, neurological, or internal medicine comorbidities;
  • severe rigidity or hypertonia;
  • severe visual deficit;
  • pregnancy women

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Telerehabilitation with Immersive Virtual Reality (TR Group)
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.
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.
Aktivní komparátor: Conventional Rehabilitation (Control Group)
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.
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adherence rate to the telerehabilitation protocol
Časové okno: 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.
End of treatment (T1, Week 4)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Berg Balance Scale (BBS)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Timed Up and Go Test (TUG)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Falls Efficacy Scale (FES)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
10-Meter Walk Test (10-MWT)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
6-Minute Walk Test (6-MWT)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
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)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Barthel Index (BI)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Trail Making Test (TMT)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
15-Word Memory Test (15-WMT)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Corsi Span Test (CS)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
Digit Span Test (DS)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
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)
Časové okno: Baseline (T0, Week 0); Post-treatment (T1, Week 4); Follow-up (T2, Month 3 after end of treatment)
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.
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)
Časové okno: Post-treatment (T1, Week 4)
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.
Post-treatment (T1, Week 4)
Perceived usability of the VR-based telerehabilitation system (SUS)
Časové okno: Post-treatment (T1, Week 4)
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.
Post-treatment (T1, Week 4)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. července 2026

Dokončení studie (Odhadovaný)

1. prosince 2026

Termíny zápisu do studia

První předloženo

17. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

7. května 2026

První zveřejněno (Aktuální)

13. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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