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In Home VR Therapy

9. juni 2021 opdateret af: James Patton, Shirley Ryan AbilityLab

Multi-user Virtual Training for Upper Extremity in the Home

Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.

Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.

Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.

The investigators hope to address two aims:

Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.

Aim 2: To determine if in-home virtual reality treatment results in greater practice

The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60601
        • Rehabilitation Institute of Chicago

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

21 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Are between the ages of 21 and 80
  • Experienced a single stroke at least 6 months prior to enrollment
  • Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale
  • Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)

Exclusion Criteria:

  • Other neurological, neuromuscular, or orthopedic disease
  • Pain in the upper extremity with movements required in the treatment
  • Contracture that limits use of the VR system
  • Vision problems which would preclude the ability to use the VR system
  • Cognitive or language deficits that would prevent them from understanding the tasks
  • Concurrent enrollment in another intervention study involving the affected arm or hand
  • Botox injection in the arm within the previous 6 months

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Enhedens gennemførlighed
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single-User Mode first, Multi-User Mode second
Andet: Single-User Virtual Reality Upper Extremity Therapy
Virtual Reality games with the user as the only person required for participation
Andre navne:
  • Single-User Mode
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
Andet: Multi-User Virtual Reality Upper Extremity Therapy
Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
Andre navne:
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Multi-User Mode
Eksperimentel: Multi-User Mode first, Single-User Mode second
Andet: Single-User Virtual Reality Upper Extremity Therapy
Virtual Reality games with the user as the only person required for participation
Andre navne:
  • Single-User Mode
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
Andet: Multi-User Virtual Reality Upper Extremity Therapy
Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
Andre navne:
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Multi-User Mode

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hand displacement during each session
Tidsramme: Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Therapy mode amount of use
Tidsramme: 2 week treatment phase
Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
2 week treatment phase
Change in Active Range of Motion
Tidsramme: First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
Change from baseline in angle of upper extremity movement (shoulder and elbow)
First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
Comparison of Intrinsic Motivation Inventory Score between therapy modes
Tidsramme: First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.
Difference in Intrinsic Motivation Inventory score between single-user and multi-user modes
First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.

Samarbejdspartnere og efterforskere

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

Sponsor

Shirley Ryan AbilityLab

Efterforskere

  • Ledende efterforsker: James Patton, PhD, Shirley Ryan AbilityLab

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

26. januar 2017

Primær færdiggørelse (Faktiske)

31. maj 2018

Studieafslutning (Faktiske)

30. maj 2020

Datoer for studieregistrering

Først indsendt

19. februar 2017

Først indsendt, der opfyldte QC-kriterier

22. februar 2017

Først opslået (Faktiske)

23. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU00204187

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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