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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Stroke
• Intervention / Treatment: Other: Early standardized task training

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: ESTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Baylor Health Care System; St.David's Rehabilitation Hospital (Austin, Texas)
• Investigators: Principal Investigator: Karen J McCain, PT, DPT, NCS, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 18, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: acute; stroke; gait
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ESTT