Evaluation of Early Standardized Task-Specific Training (ESTT)

Acute Stroke Clinical Trial

— ESTT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01774110
• Other study ID #: ESTT
• Status: Terminated
• Phase: N/A
• First received: January 18, 2013
• Last updated: September 1, 2015
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke

Intervention

Other:
• Early standardized task training
Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.

Locations

Country	Name	City	State
United States	St. David's Rehabilitation Hospital	Austin	Texas
United States	Baylor Institute for Rehabilitation - Dallas	Dallas	Texas
United States	Baylor Institute for Rehabilitation - Northwest	Dallas	Texas
United States	Baylor Institute for Rehabilitation - Frisco	Frisco	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Baylor Health Care System, St.David's Rehabilitation Hospital (Austin, Texas)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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.	No
Secondary	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	No