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临床试验/NCT02498548
NCT02498548已完成不适用

Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Intervention for Hip and Knee Function

Ohio State University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2015年6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
49
试验地点
2
主要终点
Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)

研究概览

简要总结

This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at moderate speeds - targeted to rehabilitation eccentric function of the knee or hip.

详细描述

Lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with SCI. This proposal aims to characterize eccentric motor control of the muscles about the knee or hip during locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an intervention to improve eccentric function of the knee joint or hip joint during walking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • medically approved
  • discharged from outpatient rehabilitation for 6 months
  • incomplete SCI based on ASIA impairment score (AIS C or D) at neurologic level C1-T10
  • ability to take some steps overground and on the treadmill
  • 18-90 years old.
  • ability to speak English. Note: the quality of life measures have not been validated yet in non-English speaking populations.

排除标准

  • evidence of lower motor neuron injury in the legs
  • use of botox in the past 3 months
  • pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, HIV)
  • acute deep vein thrombosis
  • skin wounds in regions where harness or hands provide support
  • pregnancy. Note: Persons who are pregnant will not be enrolled as exercise tolerance is unknown in these women with SCI.
  • cognitive conditions that preclude providing informed consent
  • ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment
  • persistent orthostatic hypotension (drop of BP >30mmHg in treadmill and harness equipment)
  • hospitalization for myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study
  • participation in any other concurrent exercise programs.
  • Note: Use of anti-spasticity and other medications (dose, frequency) will be monitored throughout training and used as a confounding variable in the analyses.

结局指标

主要结局

Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)

时间窗: baseline, 12 weeks

次要结局

  • Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)(baseline, 12 weeks)
  • Change from baseline in peak magnitude of sagittal knee power absorption or frontal Hip power during loading response(baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Basso

Professor

Ohio State University

研究点 (2)

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