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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Early Standardized Task Training

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.


Participant Flow:   Overall Study
    Early Standardized Task Training
STARTED   12 
COMPLETED   5 
NOT COMPLETED   7 
Lost to Follow-up                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Early Standardized Task Training

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.


Baseline Measures
   Early Standardized Task Training 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   2 
Male   3 


  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   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 ]

3.  Other Pre-specified:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: karen.mccain@utsouthwestern.edu



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