Task-oriented Training for Stroke: Impact on Function Mobility (TOTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01322607
First received: March 22, 2011
Last updated: March 7, 2016
Last verified: March 2016
Results First Received: November 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Cerebrovascular Accident
Stroke
Interventions: Behavioral: High-intensity Treadmill Exercise
Behavioral: Low-intensity Lifestyle Intervention

  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
Hemiparetic stroke survivors (>6 months) with residual hemiparetic gait in women/men aged 30-85 years who completed all therapy were recruited. They had to have adequate language and neurocognitive function, give adequate informed consent, able to rise from a chair unaided, and able to walk 10 meters without human assistance.

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
Arm 1: High-Intensity Program

High-intensity treadmill-based exercise

High-intensity Treadmill Exercise: High-intensity treadmill walking program

Arm 2: Low-Intensity Program

Low-intensity lifestyle intervention (group exercise)

Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.


Participant Flow:   Overall Study
    Arm 1: High-Intensity Program     Arm 2: Low-Intensity Program  
STARTED     11     9  
COMPLETED     10     9  
NOT COMPLETED     1     0  



  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.
No text entered.

Reporting Groups
  Description
Arm 1: High-Intensity Program

High-intensity treadmill-based exercise

High-intensity Treadmill Exercise: High-intensity treadmill walking program

Arm 2: Low-Intensity Program

Low-intensity lifestyle intervention (group exercise)

Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.

Total Total of all reporting groups

Baseline Measures
    Arm 1: High-Intensity Program     Arm 2: Low-Intensity Program     Total  
Number of Participants  
[units: participants]
  11     9     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     6     13  
>=65 years     4     3     7  
Age  
[units: years]
Mean (Standard Deviation)
  59.36  (8.63)     61.89  (9.03)     60.5  (8.67)  
Gender  
[units: participants]
     
Female     5     6     11  
Male     6     3     9  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     9     6     15  
White     1     3     4  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     11     9     20  
BMI  
[units: kg/m2]
Mean (Standard Deviation)
  29.57  (5.73)     30.34  (7.53)     29.92  (6.43)  
Weight  
[units: kg]
Mean (Standard Deviation)
  88.92  (22.27)     86.56  (19.57)     87.86  (20.59)  
Height  
[units: cm]
Mean (Standard Deviation)
  172.79  (10.83)     169.54  (11.87)     171.33  (11.13)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Economy of Gait   [ Time Frame: 3 months ]

2.  Secondary:   Muscular Strength   [ Time Frame: 3 months ]

3.  Secondary:   Muscular Endurance   [ Time Frame: 3 months ]

4.  Secondary:   Balance   [ Time Frame: 3 months ]


  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: Research Specilist
Organization: Baltimore VA Medical Center (VAHMCS)
phone: 410-605-7156
e-mail: alyssa.stookey@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01322607     History of Changes
Other Study ID Numbers: O7194-W
Study First Received: March 22, 2011
Results First Received: November 23, 2015
Last Updated: March 7, 2016
Health Authority: United States: Federal Government