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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01322607
First received: March 22, 2011
Last updated: November 18, 2013
Last verified: November 2013

March 22, 2011
November 18, 2013
July 2011
January 2014   (final data collection date for primary outcome measure)
Economy of Gait [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01322607 on ClinicalTrials.gov Archive Site
  • Muscular strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Muscular endurance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Task-oriented Training for Stroke: Impact on Function Mobility
Task-oriented Training for Stroke: Impact on Function Mobility

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Cerebrovascular Accident
  • Stroke
  • Behavioral: High-intensity Treadmill Exercise
    High-intensity treadmill walking program
  • Behavioral: Low-intensity Lifestyle Intervention
    A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
  • Arm 1
    High-intensity treadmill-based exercise
    Intervention: Behavioral: High-intensity Treadmill Exercise
  • Arm 2
    Low-intensity lifestyle intervention (group exercise)
    Intervention: Behavioral: Low-intensity Lifestyle Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
January 2014
January 2014   (final data collection date for primary outcome measure)

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 (a) unstable angina, (b) recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II), (c) hemodynamically significant valvular dysfunction, (d) PAOD with claudication, (e) major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, (f) pulmonary or renal failure, (g) poorly controlled hypertension (>190/110), measured on at least two separate occasions (h) recent hospitalization for severe disease or surgery (i) severe or global receptive aphasia which confounds reliable testing and training.
  • Untreated major depression as documented by a CES-D score of >16 and confirmed by clinical interview.
  • Pregnancy.
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01322607
O7194-W
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Alyssa D Stookey, PhD MS Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Department of Veterans Affairs
November 2013

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