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

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.
ClinicalTrials.gov Identifier: NCT00983827
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Information provided by:
University of Utah

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
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aquatic Treadmill Training
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Aquatic Treadmill Training
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  87.5%
>=65 years
1
  12.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
53.5  (6.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Safety
Hide Description Number of procedure related adverse events that occurred during study.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquatic Treadmill Training
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: adverse events
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aquatic Treadmill Training
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Aquatic Treadmill Training
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aquatic Treadmill Training
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aquatic Treadmill Training
Affected / at Risk (%) # Events
Total   2/8 (25.00%)    
General disorders   
Sharp Head Pain [1]  1/8 (12.50%)  1
Injury, poisoning and procedural complications   
Fall [1]  1/8 (12.50%)  1
[1]
Event determined not to be related to research.
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
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