- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02781831
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
Status
Ukendt
Betingelser
Intervention / Behandling
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:
- Nai-Hsin Meng, M.D.
- Telefonnummer: 2381 886-4-22052121
- E-mail: nsmeng@ms13.hinet.net
-
Underforsker:
- Li-Wei Chou, M.D. Ph.D.
-
Underforsker:
- Pei-Yu Yang, M.D.
-
Underforsker:
- Andy Chien, Ph.D.
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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
20 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Between the age of 20-65 years;
- Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
- Paresis of a lower limb;
- Inability to walk without aid or device.
Exclusion Criteria:
- Deemed by a physician to be medically unstable;
- Other prior musculoskeletal conditions that affected gait capacity;
- Co-existence of other neurological diseases;
- 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
Yderligere relevante MeSH-vilkår
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 .
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