- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02755415
Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
26. juli 2016 oppdatert av: China Medical University Hospital
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors.
It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society.
Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength.
Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients.
However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients.
Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse.
It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Taichung, Taiwan, 408
- Rekruttering
- China Medical University Hospital
-
Ta kontakt med:
- Li-Wei Chou, MD, MSc
- Telefonnummer: 2381 +886-4-22052121
- E-post: chouliwe@gmail.com
-
Hovedetterforsker:
- Li-Wei Chou, MD, PhD, MSc
-
Underetterforsker:
- Nai-Hsin Meng, MD
-
Underetterforsker:
- Andy Chien, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Between the age of 20-80 years;
- Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
- Paresis of a lower limb;
- Ability to walk for only a few meters either with or without aid.
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Static Standing Table Training
Patients in this group will receive standard hospital based rehabilitation as well as static standing table training
|
As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
|
Eksperimentell: Robotic Gait Training
Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training
|
HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Berg Balance Scale
Tidsramme: 15-20 minutes
|
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice
|
15-20 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pittsburgh Sleep Quality Index
Tidsramme: 10-15 minutes
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders
|
10-15 minutes
|
EuroQol five dimensions questionnaire (EQ-5D)
Tidsramme: 10-15 minutes
|
EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.
|
10-15 minutes
|
Resting muscle tone
Tidsramme: 10 minutes
|
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency [Hz]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
|
10 minutes
|
Resting muscle elasticity
Tidsramme: 10 minutes
|
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness [N/m]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
|
10 minutes
|
Six minute walk test
Tidsramme: 6 minutes
|
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in six minutes.
The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
|
6 minutes
|
Beck's depression Inventory
Tidsramme: 7-10 minutes
|
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
|
7-10 minutes
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2016
Primær fullføring (Forventet)
1. april 2017
Studiet fullført (Forventet)
1. desember 2017
Datoer for studieregistrering
Først innsendt
21. april 2016
Først innsendt som oppfylte QC-kriteriene
26. april 2016
Først lagt ut (Anslag)
28. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMUH105-REC1-037
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will remain confidential and accessible to only the approved researchers
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Static Standing Table
-
Foundation University IslamabadRekruttering
-
Dokuz Eylul UniversityHar ikke rekruttert ennåGlenohumeral intern rotasjonsunderskudd
-
Spine and Scoliosis Research AssociatesPåmelding etter invitasjonDegenerativ platesykdom (DDD)Forente stater
-
Dokuz Eylul UniversityHar ikke rekruttert ennåGlenohumeral intern rotasjonsunderskudd
-
University of FloridaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aktiv, ikke rekrutterende
-
K2M, Inc.Stryker SpineTilbaketrukketCervikal ryggradsskade | Thoracolumbar ryggrad
-
University of CalgaryFullført
-
Adai Technology (Beijing) Co., Ltd.FullførtAvhengighet, stoffKina
-
Maimonides UniversityRekruttering
-
Vanderbilt UniversityAvsluttetAlbuebrudd | Fraktur i øvre ekstremitet | Brudd, findelt | Dislokasjon av albue | Øvre ekstremitetsluksasjonForente stater