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临床试验/NCT01322607
NCT01322607已完成不适用

Task-oriented Training for Stroke: Impact on Function Mobility

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Economy of Gait

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Economy of Gait

时间窗: 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.

次要结局

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

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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