Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pinch Strength
研究概览
简要总结
This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the effects of superimposing sessions of a therapy, in individuals with chronic incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.
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, Investigator)
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
- •Spinal cord lesion at level of C3 to T1
- •Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
- •Individuals must be at least 6 months status post injury
- •Individuals must be between the ages of 18-70 years inclusive, male or female
- •Spinal cord injury must be secondary to a non-progressive etiology
- •Individuals must be medically stable.
- •Able to comply with protocol/study requirements
- •Not currently (>2 weeks) taking any medications for spasticity management.
排除标准
- •Recent change in the use of narcotic, anti-inflammatory or pain medication
- •Unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study, as determined by the treating therapist
- •History of sleep apnea
- •Active participation in another movement research study or therapy program
- •Anti-spasticity drug injection less than 3 months, prior to beginning treatment
- •Musculoskeletal pain that interferes with participation in study
- •Women who are currently, may be or planning on becoming pregnant
结局指标
主要结局
Pinch Strength
时间窗: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A pinch gauge measures maximum pinch force (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively squeeze the pinch meter between the thumb and index finger. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The gauge will be placed between the thumb and lateral surface of the index finger (lateral pinch).
9 Hole Peg Test
时间窗: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A measure of finger dexterity involving the placement of pegs from a container to holes on a board, and subsequent removal, as quickly as possible. The total number of seconds until task completion is recorded, as measured by when the participant touches the first peg to when the last peg is placed back into the container.
Box and Blocks test
时间窗: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds
Change in grip strength
时间窗: Baseline, immediately following intervention, and every 30 minutes for 5 hours
A dynamometer measures maximum gross grasp (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg lb will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The forearm should be in neutral rotation. The arm should not be supported by an arm rest or research personnel.
次要结局
未报告次要终点
研究者
Milap Sandhu
Principal Investigator
Shirley Ryan AbilityLab