Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Omnidirectionele virtual reality en loopbandtraining gebruiken voor chronische beroerte (PROVE)

2 oktober 2026 bijgewerkt door: Adria Quigley, Nova Scotia Health Authority

PROVE-VR: een gerandomiseerde pilotstudie met behulp van omnidirectionele virtuele realiteit en loopbandtraining voor overlevenden van een chronische beroerte

The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (consent rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes.

Researchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors.

Participants will:

  • undergo a 45-minute training session 3 times per week for 12 weeks
  • intervention group: omni-VR
  • control group: traditional exercise program (strengthening and walking activities)

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.

Virtual reality or VR (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. It has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity.

Omnidirectional treadmill technology can be integrated with VR to allow for fully immersive rehabilitation. This novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. However, no randomized trials have evaluated the impact of omnidirectional treadmill VR (Omni-VR) on cognitive and physical function among stroke survivors.

Therefore, our study aims to test the feasibility and usability of the Omni-VR. This pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-VR system among chronic stroke survivors

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • Werving
        • Nova Scotia Rehabilitation & Arthritis Centre
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria

  • Age ≥ 18
  • Stroke ≥ 6 months ago (confirmed with chart review)
  • Living within 50 km of Halifax, Nova Scotia
  • Functional Ambulation Category of 3 or greater on a scale of 0-5, to ensure the participant is able to walk with supervision or independently. This criterion was selected to ensure participants could safely participate in the intervention.
  • Ability to participate in low-moderate intensity aerobic or strengthening exercise for ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45 minutes, with activity breaks, in keeping with previous stroke rehabilitation studies.
  • No uncorrected visual deficits or spatial neglect
  • No cardiovascular, orthopedic, or neurological diseases other than stroke impacting walking or balance
  • Can follow simple instructions
  • Score of < 27 on the adapted Motion Sickness Susceptibility Scale-Short based on established normative values indicating more than moderate susceptibility to motion sickness.

Exclusion Criteria:

  • Unstable serious medical condition
  • Resting blood pressure >180/100mmHg
  • History of abnormal untreated heart rhythm
  • Pregnancy
  • Condition limiting ability to complete or tolerate the exercises without major program modifications (e.g., chronic low back pain)
  • Serious comorbid condition that would affect participation in the intervention (e.g., active cancer, severe heart disease)
  • Severe loss of hearing or speech that would preclude VR use
  • Participant weight more than 264 lbs (weight limit for Virtualizer Elite 2 treadmill)
  • Participating in another formal lower limb exercise program > 1 day per week
  • History of QT prolongation or using potential QT prolonging drugs

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Omni-VR group

20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training.
Apparaat: Omnidirectional Virtual Reality and Treadmill Training

Omni-VR forest scenario developed by our team involving real-life dual task walking and dynamic balance activities (ie. stepping over obstacles, and managing distractions) will be used for treatment group.
Actieve vergelijker: Control group

10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks.
Gedragsmatig: Traditional Exercise

A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Consent rate
Tijdsspanne: Baseline

Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.
Baseline
Retention rate
Tijdsspanne: 12 weeks (study completion)

Retention rate is the percentage of participants who complete the 12-week intervention. The investigators expect a retention rate of 80% for the intervention group.
12 weeks (study completion)
Usability of the Omnidirectional Treadmill and Virtual Reality Game
Tijdsspanne: 12 weeks (study completion)

Usability will be assessed by System Usability Scale (SUS) out of 100 points. The investigators expect a SUS score of 71 or higher among all participants.
12 weeks (study completion)
Participant burden
Tijdsspanne: Baseline and 12 weeks (study completion)

Participant burden will be measured by the percentage of participants finishing assessments in 100 minutes or less. The investigators anticipate at least 85% of participants completing assessments within the time limit.
Baseline and 12 weeks (study completion)
Adherence
Tijdsspanne: 12 weeks (study completion)

Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions.
12 weeks (study completion)
Equipment downtime
Tijdsspanne: 12 weeks (study completion)

The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of sessions.
12 weeks (study completion)
Equipment safety
Tijdsspanne: 12 weeks (study completion)

The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study
12 weeks (study completion)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cognitive function
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will use the Computerized MoCA [Montreal Cognitive Assessment] Duo to evaluate participants' cognitive function.
Baseline and 12 weeks (study completion)
Executive Function
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function.
Baseline and 12 weeks (study completion)
Working memory
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory.
Baseline and 12 weeks (study completion)
Brain activation in prefrontal and premotor cortices
Tijdsspanne: Baseline and 12 weeks (study completion)

Brain activation using fNIRS [Functional near-infrared spectroscopy] in the prefrontal and premotor regions of interest during a single task (steady-state omnidirectional treadmill walking) and two cognitive-physical dual-task activities (simple dual-task: steady-state omnidirectional treadmill walking while repeating the same word and complex dual-task: steady-state omnidirectional treadmill walking while performing a verbal fluency test)
Baseline and 12 weeks (study completion)
Walking Speed
Tijdsspanne: Baseline and 12 weeks (study completion)

Walking speed using VIVE trackers on omnidirectional treadmill and overground
Baseline and 12 weeks (study completion)
Step cadence
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will evaluate step cadence using the VIVE trackers.
Baseline and 12 weeks (study completion)
Step width
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will evaluate step width using the VIVE trackers.
Baseline and 12 weeks (study completion)
Step length
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will evaluate step length using the VIVE trackers.
Baseline and 12 weeks (study completion)
Dynamic balance
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will measure the static sway with feet together using omni-VR system and use MINI-BESTest to measure the dynamic balance.
Baseline and 12 weeks (study completion)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Motivation of participant
Tijdsspanne: 12 weeks (study completion)

The investigators will measure motivation by intrinsic motivation inventory. Higher scores indicate better results.
12 weeks (study completion)
Health-related quality of life of participant
Tijdsspanne: Baseline and 12 weeks (study completion)

The investigators will measure health-related quality of life by the Stroke Impact Scale-3.0. Higher scores indicate better results.
Baseline and 12 weeks (study completion)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nova Scotia Health Authority

Medewerkers

Brain Canada

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 april 2025

Primaire voltooiing (Geschat)

6 augustus 2027

Studie voltooiing (Geschat)

6 september 2027

Studieregistratiedata

Eerst ingediend

20 juni 2024

Eerst ingediend dat voldeed aan de QC-criteria

3 juli 2024

Eerst geplaatst (Werkelijk)

10 juli 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

2 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PROVE_stroke

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren