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Interactive Intention-Driven Upper-Limb Training Robotic System

23. februar 2017 opdateret af: Raymond KY Tong, The Hong Kong Polytechnic University

Trial: Interactive Intention-Driven Upper-Limb Training Robotic System

The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.

Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.

There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

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 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

Exclusion Criteria:

  • Excessive spasticity of the affected arm
  • Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

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: Hand Robotic Training
Enhed: Hand Robotic Training
Training for 20 sessions for one hour, 3-5 times per week.
Eksperimentel: Hand and Arm Robotic Training
Enhed: Hand and Arm Robotic Training
Training for 20 sessions for one hour, 3-5 times per week.
Aktiv komparator: Konventionel terapi
Andet: Conventional therapy
Training for 20 sessions for one hour, 3-5 times per week.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fugl-Meyer Assessment
Tidsramme: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months

Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months.

Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
Action Research Arm Test
Tidsramme: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months

Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.

Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wolf Motor Function Test
Tidsramme: Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months

Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.

Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
modified Ashworth Scale
Tidsramme: Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months

Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.

Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months

Samarbejdspartnere og efterforskere

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

Sponsor

The Hong Kong Polytechnic University

Efterforskere

  • Ledende efterforsker: Raymond KY Tong, PhD, The Hong Kong Polytechnic University

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.

Hjælpsomme links

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. januar 2014

Primær færdiggørelse (Faktiske)

31. december 2015

Studieafslutning (Faktiske)

31. december 2016

Datoer for studieregistrering

Først indsendt

27. februar 2014

Først indsendt, der opfyldte QC-kriterier

3. marts 2014

Først opslået (Skøn)

4. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ITT/004/12GP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hand Robotic Training

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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