Evaluation of Early Standardized Task-Specific Training (ESTT)
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.
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 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|
- 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.
- 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.
- 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.
|Study Start Date:||August 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774110
|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|
|Principal Investigator:||Karen J McCain, PT, DPT, NCS||UT Southwestern Medical Center|