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Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy

25. december 2016 opdateret af: Lynne Gauthier , PhD, Ohio State University

A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis

Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

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
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University, 2154 Dodd Hall

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female aged > 17
  • Preserved ability to comprehend English and participate in basic elements of the therapy
  • Community-dwelling
  • Experienced mild to moderate hemiparesis at least six months prior
  • Can independently operate the gaming system (those with severe cognitive impairments can usually achieve this)
  • Corrected vision of at least 20/70 as assessed by their ability to identify game objects on the monitor from 5 feet away

Exclusion Criteria:

  • concurrent participation in other experimental upper extremity trials
  • concurrent participation in other outpatient rehabilitation for their upper extremity
  • Botox within the last 3 months (confound)
  • near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample)
  • minimal nonuse (Motor Activity Log at baseline >2.5, Accelerometry > 60%)
  • major medical issues that would interfere with study treatments or make intensive rehabilitation difficult to tolerate

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Slag
Adfærdsmæssigt: Hemiparesis Therapy with VR
An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids
Eksperimentel: Hemiparesis other
Adfærdsmæssigt: Hemiparesis Therapy with VR
An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Motor Activity Log
Tidsramme: Week 0 and Week 3
Self-report measure of arm use for daily activities
Week 0 and Week 3
Change in Wolf Motor Function Test
Tidsramme: Week 0 and Week 3
Objective measure of motor function in a laboratory setting
Week 0 and Week 3

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kinematic Data
Tidsramme: Week 0 and Week 3
Kinematic data recorded during game play
Week 0 and Week 3
Brief Kinesthesia test
Tidsramme: Week 0 and Week 3
Clinical Assessment of sensation
Week 0 and Week 3
Patient Health Questionnaire
Tidsramme: Week 0 and Week 3
Measures Depression
Week 0 and Week 3
Strok Specific Quality of Life Scale
Tidsramme: Week 0 and Week 3
Quality of life measurement
Week 0 and Week 3
Weschler Adult Intelligence Scale Symbol Seach
Tidsramme: Week 0 and Week 3
Cognitive processing speed assessment
Week 0 and Week 3
Montreal Cognitive Assessment
Tidsramme: Week 0 and Week 3
Baseline cognitive screen
Week 0 and Week 3
Survey
Tidsramme: Week 0 and Week 3
Survey on satisfaction with the intervention
Week 0 and Week 3
Mitt Compliance
Tidsramme: Week 0 and Week 3
Hours of use
Week 0 and Week 3
Total game-play time
Tidsramme: Week 0 and Week 3
Week 0 and Week 3
Gestures
Tidsramme: Week 0 and Week 3
Number of gestures of each type registered in game
Week 0 and Week 3
Bilateral activity monitors
Tidsramme: Week 0 and Week 3
Objective measure of arm use
Week 0 and Week 3
Action Research Arm Test (ARAT)
Tidsramme: Week 0 and Week 3
Asses Changes in Limb Function
Week 0 and Week 3

Samarbejdspartnere og efterforskere

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

Sponsor

Ohio State University

Samarbejdspartnere

Nationwide Children

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

1. juli 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

21. december 2016

Først indsendt, der opfyldte QC-kriterier

25. december 2016

Først opslået (Skøn)

29. december 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 60047824

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Will be shared upon publication acceptance.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hemiparesis Therapy with VR

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mauritania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner