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

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. Identifier: NCT01322607
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Stroke Behavioral: High-intensity Treadmill Exercise Behavioral: Low-intensity Lifestyle Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Task-oriented Training for Stroke: Impact on Function Mobility
Study Start Date : July 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Arm 1: High-Intensity Program
High-intensity treadmill-based exercise
Behavioral: High-intensity Treadmill Exercise
High-intensity treadmill walking program

Arm 2: Low-Intensity Program
Low-intensity lifestyle intervention (group exercise)
Behavioral: Low-intensity Lifestyle Intervention
A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.

Primary Outcome Measures :
  1. Economy of Gait [ Time Frame: 3 months ]
    Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.

Secondary Outcome Measures :
  1. Muscular Strength [ Time Frame: 3 months ]
    Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.

  2. Muscular Endurance [ Time Frame: 3 months ]
    Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.

  3. Balance [ Time Frame: 3 months ]
    Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years.
  • Completion of all regular post-stroke physical therapy
  • Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent.
  • Able to rise from a chair unaided.
  • Able to walk 10 meters without human assistance.

Exclusion Criteria:

  • Regular structured aerobic exercise (> 2x week).
  • Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report.
  • Clinical history of

    • unstable angina,
    • recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II),
    • hemodynamically significant valvular dysfunction,
    • Peripheral Arterial Obstructive Disease with claudication,
    • major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise,
    • pulmonary or renal failure,
    • poorly controlled hypertension (>190/110), measured on at least two separate occasions
    • recent hospitalization for severe disease or surgery
    • severe or global receptive aphasia which confounds reliable testing and training.
  • Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of >16 and confirmed by clinical interview.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01322607

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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Alyssa D Stookey, PhD MS Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Responsible Party: VA Office of Research and Development Identifier: NCT01322607    
Other Study ID Numbers: O7194-W
First Posted: March 24, 2011    Key Record Dates
Results First Posted: April 6, 2016
Last Update Posted: April 6, 2016
Last Verified: March 2016
Keywords provided by VA Office of Research and Development:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases