Evaluation of Early Standardized Task-Specific Training (ESTT)
This study is currently recruiting participants.
Verified February 2013 by University of Texas Southwestern Medical Center
Sponsor:
University of Texas Southwestern Medical Center
Collaborators:
Baylor Health Care System
St.David's Rehabilitation Hospital (Austin, Texas)
Information provided by (Responsible Party):
Karen McCain, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01774110
First received: January 18, 2013
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Stroke |
Other: Early standardized task training |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Texas Southwestern Medical Center:
Primary Outcome Measures:
- Temporal-spatial gait analysis [ Time Frame: This will be done at the time of discharge from inpatient rehabilitation, at the time of discharge from the outpatient portion of the study (if applicable) and at 6-months post enrollment. ] [ Designated as safety issue: No ]Computerized gait analysis is done by a mat system (GAITRite).
Secondary Outcome Measures:
- Stroke Rehabilitation Assessment of Movement (STREAM) [ Time Frame: This test will be done at the initiation of the protocol, at the time of discharge from inpatient rehabilitation, at the time of discharge from the outpatient portion of the study (if applicable) and at 6 months post enrollment ] [ Designated as safety issue: No ]The STREAM is a test of motor recovery after stroke.
Other Outcome Measures:
- 6-Minute Walk Test [ Time Frame: This test will be done at the initiation of the protocol, at the time of discharge from rehabilitation, at the time of discharge from the outpatient portion of the study (if applicable) 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Recent stroke(less than 4 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774110
Contacts
| Contact: Karen J McCain, PT, DPT, NCS | 214-648-1559 | karen.mccain@utsouthwestern.edu |
Locations
| United States, Texas | |
| St. David's Rehabilitation Hospital | Recruiting |
| Austin, Texas, United States, 78705 | |
| Contact: Yolanda Strickland, PT 514-544-5628 yolanda.strickland@stdavids.com | |
| Baylor Institute for Rehabilitation - Dallas | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Baylor Institute for Rehabilitation - Northwest | Not yet recruiting |
| Dallas, Texas, United States, 75247 | |
| Baylor Institute for Rehabilitation - Frisco | Not yet recruiting |
| Frisco, Texas, United States, 75034 | |
| Baylor Institute for Rehabilitation - Irving | Not yet recruiting |
| Irving, Texas, United States, 75061 | |
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Baylor Health Care System
St.David's Rehabilitation Hospital (Austin, Texas)
Investigators
| Principal Investigator: | Karen J McCain, PT, DPT, NCS | UT Southwestern Medical Center |
More Information
No publications provided
| Responsible Party: | Karen McCain, Assistant Professor, Physical Therapy, School of Health Professions, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT01774110 History of Changes |
| Other Study ID Numbers: | ESTT |
| Study First Received: | January 18, 2013 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
stroke gait acute |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013