Dose-Optimization Study of Acute Intermittent Hypoxia (DOSA-SCI): Effects on Lower-Limb Motor Function and Physiological Responsiveness in Individuals With Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in ankle plantarflexion and dorsiflexion
研究概览
简要总结
This study aims to evaluate how different doses of acute intermittent hypoxia (AIH) affect lower-limb strength, reaction time, and responsiveness in individuals with spinal cord injury (SCI). The objective is to identify the dose that most effectively improves motor output while also examining parameters that may account for variability in response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will not know if they are receiving AIH or Sham AIH
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
- 否
入选标准
- •Chronic Spinal Cord Injury (>6 months)
- •Motor incomplete SCI classified as AIS C or D
- •Volitional ankle plantarflexion strength in at least one leg
排除标准
- •Uncontrolled hypertension (outside 140/90 and 90/60)
- •Concurrent medical illness
- •Traumatic brain injury
- •Cardiovascular complications
- •Pulmonary complications
- •Metabolic dysfunction
- •Continued use of anti-spasticity medications
- •Previously diagnosed obstructive sleep apnea
结局指标
主要结局
Change in ankle plantarflexion and dorsiflexion
时间窗: Immediately following Intervention
Measurement of ankle force during a maximum voluntary contraction while pushing or pulling on a force plate
Lower Limb Reaction time
时间窗: Immediately following intervention
Assessed using visual, auditory, and combined cueing tasks, reaction time will be quantified as the time from cue presentation to muscle activity onset
次要结局
- Hypoxic Ventilatory Response(During intervention)
- SpO2 burden(During intervention)
研究者
Milap Sandhu
Principal Investigator
Shirley Ryan AbilityLab