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Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

29. juni 2026 opdateret af: Hee-Tae Jung, Indiana University

Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Stroke Survivors

The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help stroke survivors improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for stroke survivors.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

After obtaining consent and screening, eligible participants are randomized to the treatment or control groups.

First, all participants are issued a wearable tracker to gauge baseline activity for at least 5 days.

During the intervention phase, participants undergo 12 treatment sessions, 2x a week for 6 weeks.

Assessments are conducted at pre-intervention, post-intervention, and 1-month followup.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Peter Altenburger, Ph.D., PT
  • Telefonnummer: 317-278-0703
  • E-mail: paltenbu@iu.edu

Undersøgelse Kontakt Backup

  • Navn: Hee-Tae Jung, Ph.D.
  • Telefonnummer: 317-278-1285
  • E-mail: heetjung@iu.edu

Studiesteder

  • Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Rekruttering
        • Indiana University Health, Neurorehabilitation & Robotics
        • Kontakt:
          • Peter Altenburger, Ph.D., PT
          • Telefonnummer: 317-278-0703
          • E-mail: paltenbu@iu.edu
        • Ledende efterforsker:
          • Peter Altenburger, Ph.D., PT
        • Underforsker:
          • Hee-Tae Jung, Ph.D.
        • Kontakt:
          • Kathryn Gyves, PT, DPT, NCS, CSRS, AVPT, CBIS
          • Telefonnummer: 317-963-7050
          • E-mail: kgyves@iuhealth.org

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Diagnosis: Anischemic or hemorrhagic stroke verified by imaging, confirmed by the patient's physician, and 1-6 months post-stroke (subacute phase)
  • Motor Impairment Level: Functional Ambulation Category (FAC) 3-5, showing moderate impairment while still allowing safe participation in gait tasks.
  • Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score >= 20, indicating sufficient cognitive function to participate in the study.
  • Exercise Clearance: Approval from a physician for participation in exercise- and VR-based interventions.
  • Rehabilitation Need: 10-Meter Walk Test <1.0 m/s, as timed by a PT during screening, indicating a need for functional rehabilitation.
  • Consent: Must be able to provide informed consent for themselves.

Exclusion Criteria:

  • Participants with uncontrolled cardiovascular, orthopedic, or metabolic conditions or unstable medication regimens that could interfere with their participation in the study.
  • Any comorbidity that could interfere with walking or gait training.
  • Participation in robot- or VR-assisted gait training within the last 6 months.
  • Intolerance to virtual reality environments or motion simulation.
  • Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.
  • Any other condition deemed unsafe or confounding by investigator, such as pre-existing neurological conditions unrelated to stroke (e.g. Parkinson's, multiple sclerosis), unmanaged pain medications, or acute medical events during the screening period (e.g. recurrent stroke, hospitalization).
  • Individuals who score a 12 or higher on the Disability Rating Scale.
  • Recent Therapy: Participants should not have received physical therapy (PT) within the last month.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Konventionel løbebåndsbaseret VR-gangterapi
Deltagere i kontrolgruppen (VR-CTGT) vil deltage i ganguddannelse ved hjælp af C-Mill VR+ -teknologi, som involverer løbebåndassisteret, der går på en løbebånd, mens de interagerer med mindre fordybende virtuelle scenarier præsenteret på skærme.
Enhed: C-Mill VR+ by Motek
Semi-immersive, game-like environments, treadmill gait therapy
Eksperimentel: VR-Assisted Overground Gait Therapy
Participants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Focus Vision, enabling participants to practice walking in real-world environments and gait tasks.
Enhed: Walk-over-Ground
Fully-immersive, real-world environments, overground gait therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trinantal
Tidsramme: Kontinuerlig sporing fra screening til uge 10
Fitbit sporer antallet af trin (tælling) taget af deltageren.
Kontinuerlig sporing fra screening til uge 10
Rejseafstand
Tidsramme: Kontinuerlig sporing fra screening til uge 10
Fitbit sporer den samlede afstand (miles), der er rejst af deltageren.
Kontinuerlig sporing fra screening til uge 10
Activity Zone Minutes
Tidsramme: Continuous tracking from Screening to Week 10
Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak >70%). Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (>=70% max HR).
Continuous tracking from Screening to Week 10

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trinlængde
Tidsramme: Baseline, uge ​​7, uge ​​10
Med PKMAS Zeno Walkway (protokinetik) går deltagerne over en 14-fods trykmåtte for at fange gangkinematik. Trinlængde (centimeter) måler afstanden mellem hælkontaktpunktet for den ene fod til hælkontaktpunktet for den anden fod.
Baseline, uge ​​7, uge ​​10
Skridt længde
Tidsramme: Baseline, uge ​​7, uge ​​10
Med PKMAS Zeno Walkway (protokinetik) går deltagerne over en 14-fods trykmåtte for at fange gangkinematik. Stridlængde (centimeter) måler afstanden mellem på hinanden følgende hælkontaktpunkter på den samme fod.
Baseline, uge ​​7, uge ​​10
Holdningsprocent
Tidsramme: Baseline, uge ​​7, uge ​​10
Med PKMAS Zeno Walkway (protokinetik) går deltagerne over en 14-fods trykmåtte for at fange gangkinematik. Under gangcyklussen skifter hver fod mellem at være i kontakt med jorden (holdningsfase) og ikke i kontakt med jorden (svingfase). STANDCOPTION (Procent) er andelen af ​​gangcyklussen, hvor en fod forbliver i holdningsfasen.
Baseline, uge ​​7, uge ​​10
Ganghastighed
Tidsramme: Baseline, uge ​​7, uge ​​10
Med PKMAS Zeno Walkway (protokinetik) går deltagerne over en 14-fods trykmåtte for at fange gangkinematik. Ganghastighed (meter pr. Sekund) beregnes ved at dele den gåede afstand (meter) på det tid, der er taget (sekunder).
Baseline, uge ​​7, uge ​​10
10-Meter Walk Test
Tidsramme: Baseline, Week 7, Week 10
10MWT: Subjects will walk a distance of 10 meters at their normal pace while being timed, allowing assessment of gait speed and mobility.
Baseline, Week 7, Week 10
6-Minute Walk Test
Tidsramme: Baseline, Week 7, Week 10
6MWT: Subjects will walk for 6 minutes along a 30m track. Subjects may stop and rest as often as needed. Subject walking speed will be collected during the test to evaluate the rate of functional fatigue.
Baseline, Week 7, Week 10
Dynamic Gait Index
Tidsramme: Baseline, Week 7, Week 10
DGI: Subjects will complete 14 different tasks ranging from static standing to dynamic walking. All subjects will be guarded closely for safety to prevent falling.
Baseline, Week 7, Week 10
Timed Up and Go Test
Tidsramme: Baseline, Week 7, Week 10
TUG: Subjects will rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. This test is used to assess mobility, balance, walking ability, and fall risk.
Baseline, Week 7, Week 10
Step-Over Test
Tidsramme: Baseline, Week 7, Week 10
SOT: Patients will walk over a flat firm surface for 14 meters. The pathway will include a box that is one foot wide. Each participant will complete 10 passes, stepping over the obstacle (box) each time.
Baseline, Week 7, Week 10

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Interview
Tidsramme: Week 1, Week 4, Week 6
Participants will take part in 30-minute semi-structured interviews to share their thoughts on the user experience (e.g. engagement, utility, realism) and provide feedback to improve the virtual reality system.
Week 1, Week 4, Week 6
Quality of Life after Brain Injury
Tidsramme: Baseline, Week 7, Week 10
Participants will complete the Quality of Life after Brain Injury questionnaire assessing the health-related quality of life specifically tailored for individuals recovering from brain injury. The questionnaire includes 37 items. Scores range from 0 to 100, with 0 indicating the worst possible quality of life and 100 indicating the best possible quality of life; higher scores indicate better health-related quality of life.
Baseline, Week 7, Week 10
Disability Rating Scale
Tidsramme: Baseline, Week 7, Week 10
Participants will complete the Disability Rating Scale questionnaire assessing the level of disability and functional impairment. The scale includes 8 items. Scores range from 0 to 29, with 0 indicating no disability and 29 indicating extreme vegetative state; higher scores indicate greater disability and functional impairment.
Baseline, Week 7, Week 10
Cybersickness in Virtual Reality Questionnaire
Tidsramme: Week 1, Week 4, Week 6
Participants will complete the Cybersickness in Virtual Reality Questionnaire assessing physical symptoms associated with VR exposure, including nausea, dizziness, disorientation, imbalance, fatigue, and visual discomfort. The questionnaire includes 6 items rated from 1 to 7. Scores range from 6 to 42; higher scores indicate greater cybersickness symptom intensity.
Week 1, Week 4, Week 6
Igroup Presence Questionnaire
Tidsramme: Week 1, Week 4, Week 6
Participants will complete the Igroup Presence Questionnaire measuring the user's sense of presence and immersion in VR, such as perceived realism and awareness. The questionnaire includes 14 items using a 7-point Likert scale ranging from -3 to +3. Negatively worded items will be reverse-scored. Scores range from -42 to +42; higher scores indicate greater perceived presence.
Week 1, Week 4, Week 6
Perceived Walking Experience Questionnaire
Tidsramme: Week 1, Week 4, Week 6
Participants will complete the Perceived Walking Experience Questionnaire, which compares walking in VR with real-world walking in terms of comfort, gait differences, headset-related limitation, and safety concerns. The questionnaire includes 5 items rated from 1 to 5. Scores range from 5 to 25; higher scores indicate a less favorable perceived VR walking experience in relation to real-world walking. This questionnaire is adapted from Horsak et al. (2021), "Overground Walking in a Fully Immersive Virtual Reality."
Week 1, Week 4, Week 6
Virtual Reality System Usability Questionnaire
Tidsramme: Week 1, Week 4, Week 6
Participants will complete the Virtual Reality System Usability Questionnaire assessing the usability of the VR system, including responsiveness, clarity, learnability, enjoyment, errors, adverse symptoms, and mental burden. The questionnaire includes 9 items rated from 1 to 5. Negatively worded items will be reverse-scored. Scores range from 9 to 45; higher scores indicate greater perceived VR system usability.
Week 1, Week 4, Week 6
NASA Task Load Index
Tidsramme: Week 1, Week 4, Week 6
Participants will complete the National Aeronautics and Space Administration Task Load Index measuring perceived task workload across mental demand, physical demand, temporal demand, performance, effort, and frustration. The questionnaire includes 6 items. Scores range from 0 to 100; higher scores indicate greater perceived workload.
Week 1, Week 4, Week 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indiana University

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Ledende efterforsker: Hee-Tae Jung, Ph.D., Indiana University, Luddy School of Informatics, Computing, and Engineering
  • Ledende efterforsker: Peter Altenburger, Ph.D., PT, Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 31406
  • 1R03HD120509-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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