Evaluation of Early Standardized Task-Specific Training (ESTT)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Stroke

Intervention / Treatment
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* Other: Early standardized task training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early standardized task training<br>Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke. | Other: Early standardized task training<br>* Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.<br>* Other names: ESTT;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, gait, acute