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

This study has been terminated.
(Very limited enrollment)
Sponsor:
Collaborators:
Baylor Health Care System
St.David's Rehabilitation Hospital (Austin, Texas)
Information provided by (Responsible Party):
Karen McCain, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01774110
First received: January 18, 2013
Last updated: September 1, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention
Acute Stroke
Other: Early standardized task training

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Early Standardized Task-Specific Training (ESTT) in Persons With Acute Stroke

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.


Secondary Outcome Measures:
  • Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study. [ Time Frame: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment [ Time Frame: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment ] [ Designated as safety issue: No ]
    The 6-Minute Walk Test is a test of walking endurance and walking velocity.


Enrollment: 12
Study Start Date: August 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: early standardized task training
Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.
Other: Early standardized task training
Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
Other Name: ESTT

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774110

Locations
United States, Texas
St. David's Rehabilitation Hospital
Austin, Texas, United States, 78705
Baylor Institute for Rehabilitation - Dallas
Dallas, Texas, United States, 75246
Baylor Institute for Rehabilitation - Northwest
Dallas, Texas, United States, 75247
Baylor Institute for Rehabilitation - Frisco
Frisco, Texas, United States, 75034
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Baylor Health Care System
St.David's Rehabilitation Hospital (Austin, Texas)
Investigators
Principal Investigator: Karen J McCain, PT, DPT, NCS UT Southwestern Medical Center
  More Information

Responsible Party: Karen McCain, Associate Professor, Physical Therapy, School of Health Professions, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01774110     History of Changes
Other Study ID Numbers: ESTT 
Study First Received: January 18, 2013
Results First Received: May 13, 2015
Last Updated: September 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
stroke
gait
acute

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 21, 2016