Domiciliary VR Rehabilitation
29. februar 2016 opdateret af: Paul Verschure, Universitat Pompeu Fabra
The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
39
Fase
- Ikke anvendelig
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
45 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of Hemorrhagic or ischemic stroke
- Subject had the stroke more than 12 months ago.
- Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke.
- Age between 45 and 85 years old.
- Subject has previous experience using the RGS system in the clinic.
Exclusion Criteria:
- Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: VR-based therapy
3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.
|
3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
|
|
Aktiv komparator: Control
3 weeks of home-based occupational therapy for motor training.
|
3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in depression as measured by the Hamilton scale
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
|
Change in motor function as measured by the Medical Research Council scale
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
|
Change in spasticity for the upper arms as measured by the Ashworth scale
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
|
Change in cognitive function as measured by the Mini-mental State Evaluation test
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
|
Change in Grip Force as measured by a grip dynamometer
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
|
Change in shoulder pain as measured by the Visual Analog Assessment scale
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
|
Change in motor function as measured by the upper extremity Fugl-Meyer Assessment
Tidsramme: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Paul Verschure, PhD, Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).
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.
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. november 2011
Primær færdiggørelse (Faktiske)
1. juli 2013
Studieafslutning (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først indsendt
25. februar 2016
Først indsendt, der opfyldte QC-kriterier
29. februar 2016
Først opslået (Skøn)
4. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AAL-2008-1-1191
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 .