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Home-based -Virtual Reality Intervention for Stroke Rehabilitation (Home-VR)

12. februar 2016 opdateret af: Sheba Medical Center

Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)

On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. However, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. The use of video-games for self-training might answer this challenge.

Therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. Specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention.

Individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Ramat Gan, Israel
        • Sheba medical center

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 6 to 36 months after stroke onset
  • lived in the community with family or a caregiver
  • mild to moderate weakness the affected upper extremity
  • without significant cognitive deficit
  • able to walk at least 10-meters (with or without assistance).

Exclusion Criteria:

  • Other neurological conditions
  • Epilepsy

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
Eksperimentel: self-training using video-games
Participants will receive a video-game console and will be asked to play video-games for one hour a day X 6 days a week for 5 weeks.

Individuals will receive a video-game console and will be taught how to play the games.

They will be requested to play 60 minutes a day for 5 weeks.

Aktiv komparator: traditional self-training
Participants will receive a manual and kit of a traditional self-training program and will be asked to perform the program one hour a day X 6 days a week for 5 weeks.
Individuals will receive a manual and equipment and will be taught how to perform the exercises. They will be requested to perform the exercises 60 minutes a day for 5 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
self-training time
Tidsramme: week 9
Self-training time for the 5-week program as documented on a daily log sheet by the participants in both self-training programs. The mean weekly training hours per week will also be calculated.
week 9
Change in Action Research Arm Test
Tidsramme: week 0, week 4, week 9, week 13
change in functional ability of the weaker upper extremity
week 0, week 4, week 9, week 13

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Box and Block Test
Tidsramme: week 0, week 4, week 9, week 13
Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test
week 0, week 4, week 9, week 13
Change in The Functional Reach Test
Tidsramme: week 4, week 9, week 13
Change in standing balance
week 4, week 9, week 13
Daily enjoyment from the self-training
Tidsramme: week 9
For each daily session participants rated their perceived enjoyment (1-5 points).
week 9
Change in the Motor Activity Log (MAL)
Tidsramme: week 0, week 4, week 9, week 13
Change in daily use of the weaker upper extremity by using the MAL. This self-report questionnaire generates two seperate scores ranging from 0 to 5, regarding the amount and quality of the weaker upper extremity
week 0, week 4, week 9, week 13
Daily exertion from the self-training
Tidsramme: week 9
For each daily session participants rated their perceived exertion (6-20 on the Borg scale). A mean score will be calculated per week.
week 9
Satisfaction from the self-training program
Tidsramme: week 9
Satisfaction from the 5-week program and their perceived benefit from the program for improving their weaker upper extremity and balance on a 5-point Likert scale from "not at all" to "very much".
week 9

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Studieleder: Debbie Rand, OT, PhD, Tel Aviv University

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 2014

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

22. februar 2015

Først indsendt, der opfyldte QC-kriterier

18. marts 2015

Først opslået (Skøn)

19. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SHEBA-14-1764-HW-CTIL

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

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