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Robot-assisted Gait Training for Patients With Stroke

26. juli 2016 opdateret af: China Medical University Hospital

Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke

Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.

Studieoversigt

Detaljeret beskrivelse

Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Taichung City, Taiwan, 404
        • Rekruttering
        • China Medical University Hospial
        • Ledende efterforsker:
          • Nai-Hsin Meng, M.D.
        • Kontakt:
        • Underforsker:
          • Li-Wei Chou, M.D. Ph.D.
        • Underforsker:
          • Pei-Yu Yang, M.D.
        • Underforsker:
          • Andy Chien, Ph.D.

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

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Between the age of 20-65 years;
  2. Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
  3. Paresis of a lower limb;
  4. Inability to walk without aid or device.

Exclusion Criteria:

  1. Deemed by a physician to be medically unstable;
  2. Other prior musculoskeletal conditions that affected gait capacity;
  3. Co-existence of other neurological diseases;
  4. Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -

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
Aktiv komparator: Standard Rehabilitation
Patient with stroke receiving standard hospital based rehabilitation program
Standard hospital based rehabilitation for patients with stroke
Eksperimentel: Robot-assisted Rehabilitation
Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program
An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fugl-Meyer Assessment, lower extremity subscale
Tidsramme: Assessing change from baseline after 1 month of intervention
Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
Assessing change from baseline after 1 month of intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Ambulation Categories
Tidsramme: Assessing change from baseline after 1 month of intervention
Categorizes patients according to basic motor skills necessary for functional ambulation
Assessing change from baseline after 1 month of intervention
10 Meters Walking Test
Tidsramme: Assessing change from baseline after 1 month of intervention
Assesses walking speed in meters per second over a short duration
Assessing change from baseline after 1 month of intervention
Berg Balance Scale
Tidsramme: Assessing change from baseline after 1 month of intervention
testing a participant's static and dynamic balance abilities
Assessing change from baseline after 1 month of intervention
Timed Up and Go test
Tidsramme: Assessing change from baseline after 1 month of intervention
Assess a participant's mobility and requires both static and dynamic balance
Assessing change from baseline after 1 month of intervention
Kinetic and Kinematic Gait Analysis
Tidsramme: Assessing change from baseline after 1 month of intervention
The temporo-spatial and kinematic gait parameters of the participants will be assessed using a Vicon Motion Analysis System with kinetic data collection through a force plate.
Assessing change from baseline after 1 month of intervention

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Nai-Hsin Meng, M.D., China Medical University, China Medical University Hospital

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. maj 2016

Primær færdiggørelse (Forventet)

1. juni 2018

Studieafslutning (Forventet)

1. december 2018

Datoer for studieregistrering

Først indsendt

3. maj 2016

Først indsendt, der opfyldte QC-kriterier

20. maj 2016

Først opslået (Skøn)

25. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HIWIN-CMU-C-105-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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 .

Kliniske forsøg med Cerebrovaskulær ulykke

Kliniske forsøg med Standard rehab

3
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