Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients
23. oktober 2016 opdateret af: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial
The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
54
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Seoul, Korea, Republikken, 142884
- Rekruttering
- National Rehabilitation Center
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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
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- first-ever ischemic or hemorrhagic stroke
- wrist extensor of medical research council scale 1~3
- No clinical evidence of limited passive range of motion of affected wrist
Exclusion Criteria:
- age <18 years
- severe aphasia resulting in communication difficulties confounding intervention and outcome measures
- severe cognitive impairment resulting cooperation difficulties
- spasticity > modified Ashworth scale 1+
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 |
|---|---|
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Eksperimentel: Smart glove system with functional electrical stimulation
game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity
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Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity
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|
Aktiv komparator: Functional electrical stimulation
functional electrical stimulation on upper extremity
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Functional electrical stimulation on distal upper extremity
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Wolf Motor Function Test
Tidsramme: 4 weeks from baseline
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4 weeks from baseline
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Fugl-Meyer Assessment-hand & wrist
Tidsramme: 4 weeks from baseline
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4 weeks from baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Wolf Motor Function Test
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Box and Block Test
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
number of block transferred by hand from one box to other box.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Fugl-Meyer Assessment upper extremity
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
global assessment of upper extremity impairment
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Stroke Impact Scale
Tidsramme: baseline, 4 weeks after baseline
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baseline, 4 weeks after baseline
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Motor Activity Log
Tidsramme: baseline, 4 weeks after baseline
|
baseline, 4 weeks after baseline
|
|
|
Medical research council scale of elbow flexion/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
|
Medical research council scale of wrist flexion/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
|
Range Of Motion of elbow flexion/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Range Of Motion of wrist flexion/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
|
Brunnstrom stage
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
It represent the recovery status among stroke patients
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Jebsen-Taylor hand function test
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
|
Modified Ashworth scale of elbow flexor/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
|
Modified Ashworth scale of wrist flexion/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
|
Modified Tardieu scale of elbow flexor/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
|
Modified Tardieu scale of wrist flexion/extension
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
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Adverse events
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Any adverse events
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. februar 2015
Primær færdiggørelse (Forventet)
1. oktober 2016
Studieafslutning (Forventet)
1. oktober 2016
Datoer for studieregistrering
Først indsendt
8. maj 2016
Først indsendt, der opfyldte QC-kriterier
11. maj 2016
Først opslået (Skøn)
13. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NRC-2015-01-004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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