跳至主要内容
临床试验/NCT02274116
NCT02274116进行中(未招募)不适用

Repetitive Exposure of Intermittent Hypoxia to Enhance Walking Recovery in Persons With Chronic Spinal Cord Injury

Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Change in overground walking endurance

研究概览

简要总结

The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation over time.

The investigators hypothesize:

  • Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI)
  • AIH exposure will increase multijoint reflex excitability of leg muscles in persons with incomplete cervical SCI
  • AIH exposure will increase walking performance in persons with incomplete cervical SCI

详细描述

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury. Repetitive exposure to mild hypoxia triggers a cascade of events in the spinal cord, including new protein synthesis and increased sensitivity in the circuitry necessary for breathing and walking. Recently, the investigators demonstrated that daily (5 consecutive days) of intermittent hypoxia stimulated walking enhancement in persons with chronic spinal cord injury.

Despite these exciting findings, important clinical questions remain. For example, the investigators do not know if prolonged, but less intense intermittent hypoxia induces longer-lasting motor recovery as has been shown in rat models. The investigators hypothesize that repetitive exposures to modest bouts of low oxygen will enhance and prolong walking recovery in persons with chronic spinal cord injury. The investigators anticipate intermittent hypoxia-induced improvements in overground walking ability, likely due to greater balance in excitatory and inhibitory neural transmission. Whereas excitatory inputs drive walking, inhibitory inputs sculpt and coordinate muscle activity; yet so often remain compromised after chronic injury. Thus, the investigators also predict that repetitive exposures to intermittent hypoxia will result in improved inhibition and subsequently enhance muscle coordination during walking. The investigators will use multiple experimental approaches, including muscle electromyography, measurements of walking dynamics and stretch reflexes. Finally, it is critical to assure that repetitive exposures to intermittent hypoxia do not elicit pathologies characteristic of more severe, chronic hypoxia experienced by individuals with obstructive sleep apnea. The investigators will confirm that repetitive exposure to mild bouts of intermittent hypoxia is safe.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • 18 to 75 years old (the latter to reduce likelihood of heart disease);
  • medically stable with clearance from physician to participate;
  • motor---incomplete SCI at C2---L5 with non---progressive etiology;
  • >6 months since SCI to ensure minimal confounds of spontaneous neurological recovery;
  • those classified as ambulatory must have the ability to advance one step overground without human assistance.

排除标准

  • concurrent illness, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection, cardiovascular disease, osteoporosis (history of fractures), active heterotopic ossification, or known history of peripheral nerve injury to legs;
  • less than 24 on the Mini-mental Exam;
  • recurrent autonomic dysreflexia
  • cardiopulmonary complications
  • concurrent physical therapy
  • pregnancy because of unknown effects of AIH on a fetus, although women will not otherwise be excluded

结局指标

主要结局

Change in overground walking endurance

时间窗: Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks

walking endurance (6 minute walk test - how far one can walk in 6 minutes)

次要结局

  • Change in overground walking speed(Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks)

研究者

发起方
Spaulding Rehabilitation Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Randy Trumbower, PT, PhD

Assistant Professor

Spaulding Rehabilitation Hospital

研究点 (2)

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