跳至主要内容
临床试验/NCT02115685
NCT02115685已完成不适用

Sympathetic-Somatomotor Coupling in Human Spinal Cord Injury

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年4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
40
试验地点
2
主要终点
Arterial blood flow

研究概览

简要总结

Significance: The long term objective of this study is to improve physical therapy and fitness programs in people with spinal cord injury. The results of the study will demonstrate the importance of matching blood flow to a muscle with exercise of that same muscle.

Scientific Objective: The objective of the study is to measure how the body regulates bloodflow to a muscle during exercise. We intend to study these effects by triggering blood flow changes during movement, and measuring bloodflow changes during exercise in people with spinal cord injury. We will also look at the long term effects of different exercise programs on bloodflow during exercise.

Study Populations: This study will involve people with partial spinal cord injury and age and sex matched controls without injury.

Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) upper body ergometry, 2) treadmill training with exertion level matched to the upper body ergometry and 3) treadmill training with heart rate matched to an initial test of upper body ergometry.

详细描述

The regulation of cardiovascular systems during muscle activity is poorly understood in people with incomplete spinal cord injury (SCI). In the past, disruptions in somatomotor and sympathetic control have been investigated separately in SCI. We propose to investigate the coupling of sympathetic and somatomotor control because it is relevant to exercise training paradigms that are designed to improve somatomotor function or enhance physical fitness. Our approach will be to measure tendon tap reflexes, voluntary muscle activation, and blood flow of the knee (below injury) and elbow (above injury) before and after sympathetic stimuli consisting of cold pressor tests, mental math and an acute bout of exercise. These data will provide information about sympathetic control of blood flow during muscle activity. Plasticity of the sympatheticsomatomotor coupling will also be investigated by making measurements before and after a treadmill training exercise program. These experiments will enable us to address three aims. Aim 1 will be to characterize coupling of sympathetic and somatomotor systems below the level of spinal injury. This aim will examine spinal sympathetic and motor reflexes and their interactions. It will also examine how descending somatomotor coupling is disrupted by the spinal injury. In Aim 2, we will identify changes in the interactions of sympathetic and somatomotor systems above a spinal injury. Because of the injury and the changes that occur below the injury, the sympathetic-somatomotor coupling is also likely to be disrupted in the arm. Aim 3 will then demonstrate plasticity of sympathetic-somatomotor coupling after exercise training. Three different eight week exercise training programs will be tested including 1) treadmill training with exertion level matched to 70-80% of HRR 2)treadmill training with 30-40% HRR. The exercise training will be tested in a randomized crossover study design with one month between exercise training paradigms. We anticipate that there will be plasticity of sympathetic-somatomotor coupling and that the exercise training effects will normalize control of these systems. However, because of the injury, we anticipate that adaptations will differ from non-injured controls.

This study has implications for exercise training in human SCI. The coupling of sympathetic and somatomotor systems is expected to depend on whether exercise targets the upper or lower body. The recovery of function requires both the improvement in the control of movement as well as in the regulation of blood flow to active muscle groups. In addition, this study is important for understanding the potential impact of treadmill exercise training on cardiovascular fitness, a topic of increasing interest in people with limitations to physical activity.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • incomplete SCI
  • subjects will be over age 18
  • to fit in the apparatus and to assure a mature gait pattern
  • at least 6 months post injury, and medically stable with an incomplete lesion between levels T1-T10
  • lower extremity motor score of 10 or greater
  • presence of intact stretch reflexes, detected clinically
  • no previous history or evidence of peripheral nerve damage in the lower extremities
  • Subjects must be able to step on a treadmill with no more than 40% body weight support.
  • Healthy controls will be age and sex matched to the subjects with spinal cord injury.

排除标准

  • unhealed decubiti,
  • bladder or other infection
  • severe contracture or osteoporosis
  • heterotopic ossification
  • cardiac arrhythmia
  • inability to give informed consent
  • an episode of autonomic dysreflexia in the past year
  • use of spasticity or cardiovascular medications (e.g. baclofen)

结局指标

主要结局

Arterial blood flow

时间窗: 6 hours

Subject will be tested with doppler ultrasonography immediately pre and post sympathetic stressor. Testing sessions will take anywhere between 3-6 hours.

次要结局

  • Graded Treadmill Exercise Test(15 months)
  • Tendon tap reflexes(8 hours)
  • Knee torque(8 hours)
  • Heart rate(15 months)

研究者

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

Thomas G Hornby

PT, PhD

Shirley Ryan AbilityLab

研究点 (2)

Loading locations...

相似试验

Sympathetic-Somatomotor Coupling in Human Spinal... | 临床试验