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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

Tracking Information
First Submitted Date  ICMJE August 25, 2009
First Posted Date  ICMJE September 24, 2009
Results First Submitted Date July 2, 2012
Results First Posted Date January 15, 2013
Last Update Posted Date January 15, 2013
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Safety [ Time Frame: 16 weeks ]
Number of procedure related adverse events that occurred during study.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
Peak and steady state VO2 and gait performance tests. [ Time Frame: Baseline, 8 week, 16 week ]
Change History Complete list of historical versions of study NCT00983827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Aquatic Treadmill Therapy for Improving Gait, Balance, Fitness and Quality of Life in Stroke Patients
Official Title  ICMJE Safety and Efficacy of Aquatic Treadmill Therapy for Improving Economy of Gait, Gait Speed, Balance, Cardiovascular Fitness, and Quality of Life in Ambulatory Adult Stroke Patients: A Pilot Study
Brief Summary This study aims to determine if Aquatic Treadmill Therapy is effective for improving economy of gait, gait speed, balance, and cardiovascular fitness in people with chronic stroke.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Ischemic or Hemorrhagic Stroke
  • Hemiparesis
Intervention  ICMJE Device: Aquatic treadmill training
HydroWorx aquatic therapy pool with an underwater, integrated and adjustable speed treadmill
Study Arms Experimental: 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.
Intervention: Device: Aquatic treadmill training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2011)
9
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)
10
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals with ischemic or hemorrhagic stroke with hemiparesis who have chronic deficits in gait, falls and/or poor fitness

Exclusion Criteria:

  • Subjects with medical co-morbidities that may affect gait and endurance.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00983827
Other Study ID Numbers  ICMJE 28376
ATT-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Steven Edgley, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP