Home-based -Virtual Reality Intervention for Stroke Rehabilitation (Home-VR)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Ramat Gan, Israël
- Sheba medical center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
self-training time
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Box and Block Test
Tijdsspanne: 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
Tijdsspanne: week 4, week 9, week 13
|
Change in standing balance
|
week 4, week 9, week 13
|
|
Daily enjoyment from the self-training
Tijdsspanne: week 9
|
For each daily session participants rated their perceived enjoyment (1-5 points).
|
week 9
|
|
Change in the Motor Activity Log (MAL)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Debbie Rand, OT, PhD, Tel Aviv University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SHEBA-14-1764-HW-CTIL
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .