- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02393170
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ramat Gan, Israel
- Sheba Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
self-training time
Tidsramme: week 9
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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.
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week 9
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Change in Action Research Arm Test
Tidsramme: week 0, week 4, week 9, week 13
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change in functional ability of the weaker upper extremity
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week 0, week 4, week 9, week 13
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Box and Block Test
Tidsramme: week 0, week 4, week 9, week 13
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Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test
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week 0, week 4, week 9, week 13
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Change in The Functional Reach Test
Tidsramme: week 4, week 9, week 13
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Change in standing balance
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week 4, week 9, week 13
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Daily enjoyment from the self-training
Tidsramme: week 9
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For each daily session participants rated their perceived enjoyment (1-5 points).
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week 9
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Change in the Motor Activity Log (MAL)
Tidsramme: week 0, week 4, week 9, week 13
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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
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week 0, week 4, week 9, week 13
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Daily exertion from the self-training
Tidsramme: week 9
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For each daily session participants rated their perceived exertion (6-20 on the Borg scale).
A mean score will be calculated per week.
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week 9
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Satisfaction from the self-training program
Tidsramme: week 9
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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".
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week 9
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Debbie Rand, OT, PhD, Tel Aviv University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHEBA-14-1764-HW-CTIL
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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