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

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ClinicalTrials.gov Identifier: NCT01774110
Recruitment Status : Terminated (Very limited enrollment)
First Posted : January 23, 2013
Results First Posted : June 2, 2015
Last Update Posted : October 1, 2015
Sponsor:
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Stroke
Intervention Other: Early standardized task training
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Standardized Task Training
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Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.

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

Period Title: Overall Study
Started 12
Completed 5
Not Completed 7
Reason Not Completed
Lost to Follow-up             7
Arm/Group Title Early Standardized Task Training
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Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.

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

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
1.Primary Outcome
Title Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment
Hide Description Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ESTT
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[Not Specified]
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: cm/sec
35.83  (29.36)
2.Secondary Outcome
Title Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.
Hide Description 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.
Time Frame This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Standardized Treadmill Training
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: scores on a scale
28.63  (13.78)
3.Other Pre-specified Outcome
Title Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment
Hide Description The 6-Minute Walk Test is a test of walking endurance and walking velocity.
Time Frame This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Standardized Treadmill Training
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: feet
448.66  (215.77)
Time Frame 1.5 years
Adverse Event Reporting Description no adverse events were reported
 
Arm/Group Title ESTT
Hide Arm/Group Description early standardized treadmill training
All-Cause Mortality
ESTT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ESTT
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ESTT
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Karen McCain, PT, DPT, NCS, Principal Investigator
Organization: University of Texas Southwestern Medical Center
Phone: 214-648-1559
Responsible Party: Karen McCain, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01774110     History of Changes
Other Study ID Numbers: ESTT
First Submitted: January 18, 2013
First Posted: January 23, 2013
Results First Submitted: May 13, 2015
Results First Posted: June 2, 2015
Last Update Posted: October 1, 2015