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

Primary Purpose

Acute Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early standardized task training
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring stroke, gait, acute

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. David's Rehabilitation Hospital
  • Baylor Institute for Rehabilitation - Dallas
  • Baylor Institute for Rehabilitation - Northwest
  • Baylor Institute for Rehabilitation - Frisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

early standardized task training

Arm Description

Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.

Outcomes

Primary Outcome Measures

Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment
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.
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.

Full Information

First Posted
January 18, 2013
Last Updated
September 1, 2015
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Baylor Health Care System, St.David's Rehabilitation Hospital (Austin, Texas)
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1. Study Identification

Unique Protocol Identification Number
NCT01774110
Brief Title
Evaluation of Early Standardized Task-Specific Training (ESTT)
Acronym
ESTT
Official Title
Evaluation of Early Standardized Task-Specific Training (ESTT) in Persons With Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Very limited enrollment
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Baylor Health Care System, St.David's Rehabilitation Hospital (Austin, Texas)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
stroke, gait, acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early standardized task training
Arm Type
Experimental
Arm Description
Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.
Intervention Type
Other
Intervention Name(s)
Early standardized task training
Other Intervention Name(s)
ESTT
Intervention Description
Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
Primary Outcome Measure Information:
Title
Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment
Description
Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.
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.
Secondary Outcome Measure Information:
Title
Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.
Description
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.
Time Frame
This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
Other Pre-specified Outcome Measures:
Title
Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment
Description
The 6-Minute Walk Test is a test of walking endurance and walking velocity.
Time Frame
This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J McCain, PT, DPT, NCS
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. David's Rehabilitation Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Institute for Rehabilitation - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor Institute for Rehabilitation - Northwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
Baylor Institute for Rehabilitation - Frisco
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States

12. IPD Sharing Statement

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Evaluation of Early Standardized Task-Specific Training (ESTT)

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