Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)
10. december 2012 opdateret af: Lore Van de Perre, Thomas More Kempen
Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Lore Van de Perre, MSc
- Telefonnummer: +32 14 56 23 10
- E-mail: lore.van.de.perre@khk.be
Studiesteder
-
-
Antwepen
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Geel, Antwepen, Belgien, 2440
- Thomas More Kempen
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Kontakt:
- Lore Van de Perre, MSc
- Telefonnummer: +32 14 56 23 10
- E-mail: lore.van.de.perre@khk.be
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Kontakt:
- Peter Karsmakers, PhD
- Telefonnummer: +32 14 56 23 10
- E-mail: peter.karsmakers@khk.be
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Ledende efterforsker:
- Lore Van de Perre, MSc
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Underforsker:
- Roy Sevit, MSc
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Underforsker:
- Koen Janssens, MSc
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Underforsker:
- Peter Karsmakers, PhD
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Underforsker:
- Louis Peeraer, Prof.PhD
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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
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with stroke, more than three months post onset
- No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
- Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
- Able to sit on a chair with adequate trunk stability
- Able to follow verbal instructions
- Able to communicate verbal information to the researchers
Exclusion Criteria:
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Training with the device
Training with new upper limb robot assisted therapy device
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During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
Andre navne:
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Ingen indgriben: Control group
The control group is treated with conventional therapy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fugl-Meyer test upper limb section
Tidsramme: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Stroke specific, performance based impairment index.
Applied to determine disease severity and describe motor recovery.
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Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Medical research council score
Tidsramme: Change from baseline Medical research council score at 8 weeks and 12 weeks
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Muscle strength assessment
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Change from baseline Medical research council score at 8 weeks and 12 weeks
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Active range of motion of the elbow joint
Tidsramme: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
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Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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Passive range of motion of the elbow joint
Tidsramme: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
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Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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Modified Ashworth Scale
Tidsramme: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Spasticity measurement
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Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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ABILHAND questionnaire
Tidsramme: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Questionnaire-based assessment of manual ability
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Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Functional independence measure
Tidsramme: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Assessment of physical and cognitive disability, focusing on the burden of care.
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Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Stroke impact scale
Tidsramme: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Questionnaire evaluating how stroke has impacted the person's health and life.
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Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Intrinsic motivation inventory
Tidsramme: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
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Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Lore Van de Perre, MSc, Thomas More Kempen
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 2013
Primær færdiggørelse (Forventet)
1. juli 2014
Studieafslutning (Forventet)
1. september 2014
Datoer for studieregistrering
Først indsendt
30. oktober 2012
Først indsendt, der opfyldte QC-kriterier
5. november 2012
Først opslået (Skøn)
7. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IWT120278
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 .