Age-Related Gait Changes and Hip Flexibility
2009年9月3日 更新者:University of Virginia
Based on their preliminary quantitative gait findings suggesting that limited passive hip extension range is a key functionally limiting impairment affecting gait, the investigators propose a supervised, specific stretching exercise with the aim to improve both peak hip extension and overall gait performance.
While one goal is to demonstrate that reduced peak passive hip extension is a key, functionally significant, but reversible, impairment another is to improve our understanding of the relationship between impairment, functional limitation and gait ability.
研究概览
详细说明
- Test the hypothesis that both passive and dynamic hip extension during comfortable and fast walking speeds are reduced in the elderly groups compared to passive and dynamic peak hip extension in healthy young adults.
- Test the hypothesis, separately for each elderly group, controlling for co-factors, that there is greater change in step length in the treatment group compared to the control group, after controlling for co-variates. We also expect greater changes in dynamic hip peak extension, a reduction in anterior pelvic tilt, improvement in age-related reductions in peak ankle plantar flexion and ankle power generation, and in dynamic CoM-CoP moment arm during both comfortable and fast walking, and an increase in comfortable walking speed.
- Test the hypothesis separately for the frail elderly group who cannot independently perform IADL only, controlling for co-factors, that there is a greater change in secondary, non quantitative gait-parameters of the Timed Get Up and Go Test, Activities of Daily Living, Instrumental ADL function, fear of falling and number of falls during 6 months following intervention.
- Test the hypothesis that the created forward dynamic model can accurately predict in individual subjects, the actual effect of an increase in passive peak hip extension on dynamic peak hip extension, anterior pelvic tilt, peak ankle plantar flexion and step length.
研究类型
介入性
注册 (预期的)
250
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Virginia
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Charlottesville、Virginia、美国、22903
- Department of Physical Medicine and Rehabilitation, University of Virginia
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
Healthy Elderly Adult Subjects:
- 100 subjects aged 65 years and older will be recruited from the Charlottesville area.
- Participants will be asked to fill out a health questionnaire identical to that used for all preliminary studies. This questionnaire verifies that the participants meet the inclusion criteria for the proposed research project.
- After this initial health questionnaire screening, each participant will undergo a face-to-face history and physical examination screening.
Frail Elderly Subjects:
- 100 subjects aged 65 years and older who meet the criteria of not being able to function independently, which is considered to be frail, living within the greater Charlottesville area will be recruited for participation in the study.
Exclusion Criteria:
Healthy Elderly:
- acute medical illness,
- diagnosis or symptoms of unstable angina or congestive heart failure,
- pulmonary diagnosis or symptoms of emphysema, chronic obstructive disease or asthma and shortness of breath as a result of pulmonary diagnosis brought about by walking on a flat surface,
- advanced cancer,
- neurologic diagnosis including Parkinson's Disease, stroke, brain injury, cerebellar disease, myelopathy, myopathy, peripheral neuropathy, or active radiculopathy,
- major orthopedic diagnosis in the lower back, pelvis, or lower extremities, including hip or other fracture since the age of 50, fused joint, joint replacement, or amputation,
- severe osteoarthritis or rheumatoid arthritis or active joint or musculoskeletal pain in the back or lower extremities occurring at rest or with walking,
- severe osteoporosis with a history of a fragility fracture occurring in the past 12 months, and
- regular use of an assistive device for walking.
Exclusion criteria per physical examination will be:
- physical signs of congestive heart failure,
- muscle weakness (less than 4/5 manual muscle test strength in lower extremities or focal findings of 1/5 strength difference between sides or upper and lower extremities), absent knee extensor reflexes or positive Babinski responses,
- corrected visual acuity worse than 20/100 or presence of a field defect,
- poor mental state defined with a Mini-Mental Status Examination score less than or equal to 24/30,133
- orthostatic hypotension (greater than 20mmHg decline in systolic blood pressure from supine to standing at one minute), and
- unilateral sensory deficit in lower extremities, bilateral sensory loss in stocking distribution, proprioception less than 75% correct in identifying great toe position, or vibration (from with a 128Hz tuning fork) perceived for less than 10 seconds at either the great toe or medial malleolus in either extremity.
Frail Elderly (who do not Function Independently):
- are unable to walk independently (i.e., unable to walk without the assistance of another person), or
- have either an acute medical condition or a chronic underlying medical condition which would make it unfeasible or unsafe to participate.
Regular use of an assistive device, such as a cane, for walking is not an exclusion criterion as long as:
- when using the device, the subject does not require the assistance of another person and
- the subject can walk without the assistive device (with supervisory, but not physical assistance if needed) for the length of the testing walkway, ten times (with rest periods between) at both his/her comfortable walking speed and at a faster walking speed.
Based upon the questionnaire or medical history, the following specific exclusion criteria will be used:
- acute medical illness,
- symptoms of angina or dyspnea brought about by walking on a flat surface,
- hip or knee replacement surgery or hip fracture in the previous six months,
- advanced cancer and/or life expectancy of less than 12 months,
- dementia or other illness characterized by cognitive impairment.
Based upon physical examination, subjects will be excluded if they have:
- physical signs of congestive heart failure,
- cognitive impairment defined as a Mini-Mental Status Examination score less than or equal to 24/30133 or
- orthostatic hypotension (greater than 20mm Hg decline in systolic blood pressure from supine to standing at one minute).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Hip Stretching
Kneeling Hip flexor stretch - 3 minutes a day, daily, for 10 weeks
|
Hip flexor stretch daily for 3 min x 10 weeks
其他名称:
|
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实验性的:Shoulder Stretch
Shoulder Stretch - 3 minutes daily for 10 weeks
|
Shoulder Adduction stretch - 3 minutes, daily, for 10 weeks
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Hip Extension
大体时间:10 weeks
|
10 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Hip Flexibility
大体时间:10 weeks
|
10 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Diedre C Kerrigan, MD, MS、University of Virginia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年2月1日
初级完成 (预期的)
2009年6月1日
研究完成 (预期的)
2009年12月1日
研究注册日期
首次提交
2009年6月16日
首先提交符合 QC 标准的
2009年6月17日
首次发布 (估计)
2009年6月18日
研究记录更新
最后更新发布 (估计)
2009年9月4日
上次提交的符合 QC 标准的更新
2009年9月3日
最后验证
2009年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.