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Aquatic Treadmill Therapy for Improving Gait, Balance, Fitness and Quality of Life in Stroke Patients (ATT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00983827
First Posted: September 24, 2009
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Utah
Results First Submitted: July 2, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Ischemic or Hemorrhagic Stroke
Hemiparesis
Intervention: Device: Aquatic treadmill training

  Participant Flow
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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
Aquatic Treadmill Training Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.

Participant Flow:   Overall Study
    Aquatic Treadmill Training
STARTED   8 
COMPLETED   7 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Aquatic Treadmill Training No text entered.

Baseline Measures
   Aquatic Treadmill Training 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.5  (6.48) 
Gender 
[Units: Participants]
 
Female   2 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures

1.  Primary:   Safety   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Steven Edgley
Organization: University of Utah
phone: 801-581-4695
e-mail: carma.hyde@hsc.utah.edu



Responsible Party: Steven Edgley, University of Utah
ClinicalTrials.gov Identifier: NCT00983827     History of Changes
Other Study ID Numbers: 28376
ATT-01
First Submitted: August 25, 2009
First Posted: September 24, 2009
Results First Submitted: July 2, 2012
Results First Posted: January 15, 2013
Last Update Posted: January 15, 2013