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Evaluation of Early Standardized Task-Specific Training (ESTT) (ESTT)

1. september 2015 opdateret af: Karen McCain, University of Texas Southwestern Medical Center

Evaluation of Early Standardized Task-Specific Training (ESTT) in Persons With Acute Stroke

A. Specific Aims:

1. There is one specific aim of this study. The aim is to evaluate the effectiveness of early standardized task-specific training (ESTT) in persons with acute stroke.

B. Hypothesis:

1. It is our hypothesis that subjects who receive ESTT will walk faster and more symmetrically than published reports of gait outcomes in persons with stroke.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

It is our contention that gait recovery after stroke is impacted by the interventions that are acutely utilized during training. There is not a consensus about how to most effectively train individuals after stroke. It is clear, however, that most persons are left with significant and often debilitating gait dysfunction after stroke so there is an urgent need to find more effective therapeutic methods.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • St. David's Rehabilitation Hospital
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor Institute for Rehabilitation - Dallas
      • Dallas, Texas, Forenede Stater, 75247
        • Baylor Institute for Rehabilitation - Northwest
      • Frisco, Texas, Forenede Stater, 75034
        • Baylor Institute for Rehabilitation - Frisco

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

16 år til 80 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Recent stroke (less than 6 weeks)
  • Able to give conformed consent or have family member who can give consent
  • first time stroke OR complete recovery from prior stroke

Exclusion Criteria:

  • non-ambulatory before onset of stroke
  • bilateral stroke
  • presence of severe cardiac problems
  • other co-morbidities which would affect gait training (i.e. amputation, spinal cord injury, traumatic brain injury, etc.)
  • recent myocardial infarct (within 4 weeks)
  • any uncontrolled health condition for which exercise is contraindicated
  • severe lower extremity joint disease/pathology that would interfere with gait training
  • subjects with BMI greater than 40
  • significant cognitive impairment
  • age greater than 80 years or less than 16 years
  • able to complete 5 or more full heel raises with the affected ankle in standing with the knee extended with no more than one or two fingers on support surface for balance

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: early standardized task training
Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.
Andet: Early standardized task training
Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
Andre navne:
  • ESTT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment
Tidsramme: This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.
Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.
This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.
Tidsramme: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke. There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section. Each section is scored independently and is normed to 100 points. Each of the 3 sections is then combined into a total overall function score which is also normed to 100. Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.
This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment
Tidsramme: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
The 6-Minute Walk Test is a test of walking endurance and walking velocity.
This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

Samarbejdspartnere og efterforskere

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

Sponsor

University of Texas Southwestern Medical Center

Samarbejdspartnere

Baylor Health Care System
St.David's Rehabilitation Hospital (Austin, Texas)

Efterforskere

  • Ledende efterforsker: Karen J McCain, PT, DPT, NCS, UT Southwestern Medical Center

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. august 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

18. januar 2013

Først indsendt, der opfyldte QC-kriterier

18. januar 2013

Først opslået (Skøn)

23. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ESTT

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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