Wheelchair Mobility Assessment of Individuals With Spinal Cord Injury
2014年7月21日 更新者：Mark S. Nash, Ph.D., FACSM、University of Miami
Wheelchair Propulsion Function and Physical Capacity in Persons With Spinal Cord Injury
The specific aims of this study are: 1) to assess the test-retest reliability of a modification of an existing wheelchair propulsion assessment and 2) validate the modification against traditional measures of physical strength, power, and endurance in a group of persons with spinal cord injury (SCI).
研究概览
地位
完全的
条件
详细说明
The ability to independently self-propel and transfer oneself is a crucial component of daily life for individuals with a spinal cord injury.
This ability is related in part to an individual's strength, power, and endurance, but it is unknown which of these measures is most important to achieve a high level of wheelchair function.
Identification of which physical performance parameters are best related to wheeled mobility performance is essential in developing interventions to improve said performance.
Currently, clinic-friendly assessments of a person's wheeled mobility ability do not exist.
We have developed a modified, clinic-friendly version of validated wheelchair mobility assessment that can be completed in most clinics.
Before it can be implemented by clinicians its reliability must be established.
Crossvalidating it against standard measures of physical performance will allow for the identification of the most appropriate exercise interventions to improve independent wheeled mobility.
研究类型
观察性的
注册 (实际的)
62
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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Florida
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Miami、Florida、美国、33136
- The Miami Project to Cure Paralysis
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Community sample
描述
Inclusion Criteria:
- Spinal Cord Injury
- American Spinal Injury Association Impairment Scale (AIS) A-D
- Self-reported ability to self-propel themselves in a manual wheelchair
- Age 18 or older
Exclusion Criteria:
- surgery within 6 months
- pressure ulcer within 3 months
- upper limb pain that limits completion of exercise
- recurrent acute infection or illness requiring hospitalization or IV antibiotics
- pregnancy
- previous myocardial infarction or cardiac surgery
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
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ability Score
大体时间：within a 14 day period
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The ability score is the sum of the number of items successfully completed in the wheelchair propulsion assessment.
There are 8 items in the assessement, which will be completed in the following order: 1) Figure of 8 Shape, 2) Doorstep Crossing, 3) Platform Ascent, 4) 15 meter sprint, 5) Ramp Ascent (5% grade), 6) Ramp Ascent (8% grade), 7) 150 meter propulsion, and 8) Timed Level Transfer.
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within a 14 day period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscular strength
大体时间：1 day
|
Upper extremity dynamic strength testing will be performed on a Helms equalizer 1000 multi-station exerciser using the following maneuvers: overhead press, horizontal row, vertical butterfly, biceps curl, latissimus pull down (either to the chest or neck), and dips.
The 1-repetition maximum (1-RM) will be calculated using the Mayhew regression equation.
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1 day
|
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Anaerobic power
大体时间：1 day
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Participants will propel a table-mounted Monark 894e ergometer for 30 seconds at maximal speed against constant force.
The constant resistance for each subject will be set at 1.5% and 3.5% of their body mass, for tetraplegia and paraplegia respectively.
Data for three variables will be obtained: a) peak power, defined as the highest average mechanical power measured during any 5-second period, b) mean power, the average power sustained during the 30-second test period, and c) rate of fatigue, defined as the degree of power drop-off during the test.
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1 day
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Cardiovascular endurance
大体时间：1 day
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Endurance will be measured using a calibrated upper arm ergometer.
An initial exercise workload of 0 Watts at 60 revolutions per minute (RPM) for three minutes will be followed by three minute stages increasing in 20 Watt increments.
Responses to exercise will be continuously monitored via open-circuit spirometry and 12-lead electrocardiography.
Peak Work will be defined as volitional fatigue, inability to maintain targeted workload, or the point at which increasing workload fails to further increase VO2.
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1 day
|
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：Mark S Nash, PhD、University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
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
2008年3月1日
初级完成 (实际的)
2012年2月1日
研究完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2010年9月16日
首先提交符合 QC 标准的
2010年9月16日
首次发布 (估计)
2010年9月17日
研究记录更新
最后更新发布 (估计)
2014年7月22日
上次提交的符合 QC 标准的更新
2014年7月21日
最后验证
2014年7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.