Intermittent Hypoxia-Induced Recovery of Overground Walking in Persons With Subacute SCI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Change in walking recovery, assessed by 6 minute walk test (6MWT)
研究概览
简要总结
The purpose of this study is to determine how mild breathing bouts of low oxygen may restore walking and leg strength in persons who have sustained a spinal cord injury.
详细描述
The goal of the study is to determine whether repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) improves recovery of walking and strength after spinal cord injury. This idea stems from animal studies on respiration, in which investigators showed that mild AIH improves breathing in rats with spinal injuries. These studies showed that AIH induces plasticity, strengthening neural connections by increasing the production of key proteins and improving the sensitivity of spinal cord circuitry. The ultimate goal of this research is to assess the potential of mild AIH as a therapeutic approach not only in persons with chronic spinal cord injury but also in persons with subacute injury. By applying AIH during early stages of recovery, the investigators hope to expand the potential benefits of AIH to a broader range of persons with spinal injury, thereby improving functional independence and quality of life for servicemen and civilians.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old
- •medically stable with medical clearance from physician to participate
- •spinal cord injury (SCI) at or below C3 (phrenic sparing) and above L5 with at least motor function preserved below the neurologic level
- •non-progressive etiology of spinal injury
- •American Spinal Injury Association Impairment Scale (AIS) grade A-D
- •2-12 months post-injury (subacute)
排除标准
- •severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection (e.g. bladder), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis (history of fractures), active heterotopic ossification in the lower extremities, or history of peripheral nerve injury in the legs
- •score less than 24 on Mini-Mental Exam
- •severe autonomic dysreflexia
- •history of cardiovascular/pulmonary complications
- •pregnancy
- •severe obstructive sleep apnea (OSA), characterized by uncontrolled hypoxia and sleep fractionation
- •Specific inclusion/exclusion criteria for recruiting non-ambulatory subjects:
- •Participation in this group requires all of the above inclusion/exclusion criteria, as well as being unable to complete any of the below measures:
- •timed up-and-go (TUG) test
- •10-meter walk test (10MWT)
- •6-minute walk test (6MWT)
- •Specific inclusion/exclusion criteria for recruiting ambulatory subjects:
- •Participation in this group requires all of the above criteria, as well as successful completion of at least one below measure:
- •timed up-and-go (TUG) test
- •10-meter walk test (10MWT)
- •6-minute walk test (6MWT)
研究组 & 干预措施
Non-ambulatory - dAIH
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
干预措施: Daily acute intermittent hypoxia (dAIH) (Other)
Ambulatory - dAIH+Walk
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
干预措施: Walking (Other)
Ambulatory - dSHAM+Walk
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
干预措施: dSHAM (Other)
Ambulatory - dSHAM+Walk
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
干预措施: Walking (Other)
Ambulatory-Walk
Ambulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.
干预措施: Walking (Other)
Non-ambulatory - dSHAM
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
干预措施: dSHAM (Other)
Ambulatory - dAIH+Walk
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
干预措施: Daily acute intermittent hypoxia (dAIH) (Other)
结局指标
主要结局
Change in walking recovery, assessed by 6 minute walk test (6MWT)
时间窗: Baseline, Post-session 10 (up to two weeks)
Participants perform the 6MWT at their fastest, most comfortable walking speed sustainable for 6 minutes. Distances will be recorded at 2 and 6 minutes. The test will be based upon the participant's ability to finish each assessment without human assistance. Change is the difference between the end of session 10 and baseline.
Change in walking recovery, assessed by 10 meter walk test (10MWT)
时间窗: Baseline, Post-session 10 (up to two weeks)
Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Change is the difference between the end of session 10 and baseline.
Change in walking recovery, assessed by timed up-and-go (TUG) test
时间窗: Baseline, Post-session 10 (up to two weeks)
The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair. Participants will perform up to three trials of the TUG test. Average speed across TUG trials will be used for analysis. Change is the difference between the end of session 10 and baseline.
次要结局
- Change in spasticity(Baseline, Post-session 10 (up to two weeks))
- Systemic hypertension incidence rate(Post-session 10 (up to two weeks))
- Autonomic dysreflexia incidence rate(Post-session 10 (up to two weeks))
- Change in pain severity(Baseline, Post-session 10 (up to two weeks))
研究者
Randy Trumbower, PT, PhD
Assistant Professor
Spaulding Rehabilitation Hospital