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Clinical Trials/NCT01322607
NCT01322607
Completed
Not Applicable

Task-oriented Training for Stroke: Impact on Function Mobility

VA Office of Research and Development1 site in 1 country20 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Accident
Sponsor
VA Office of Research and Development
Enrollment
20
Locations
1
Primary Endpoint
Economy of Gait
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Muscular Endurance(3 months)
  • Balance(3 months)
  • Muscular Strength(3 months)

Study Sites (1)

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