Acute Intermittent Hypoxia (AIH) Primed Myoelectric Interface Neurorehabilitation Training (MINT) for Gait Recovery in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
研究概览
简要总结
This interventional, randomized, sham-controlled study will examine whether Acute Intermittent Hypoxia (AIH) delivered immediately before Myoelectric Interface Neurorehabilitation Training (MINT)-based locomotor training improves gait in people with Multiple Sclerosis. The primary objectives are to evaluate changes in gait speed and endurance, with secondary objectives assessing spatiotemporal gait parameters, fatigue, and safety. Participants will receive AIH or sham priming followed by standardized treadmill and/or overground gait training, with outcome measures collected before and after the intervention across multiple sessions.
详细描述
The study tests whether a brief breathing treatment, acute intermittent hypoxia (AIH), can make a computer-based muscle training program (MINT) more effective for people with MS who have difficulty walking. AIH involves breathing short alternating periods of low-oxygen air (about 9% oxygen versus the roughly 21% in room air) and normal room air. The premise, drawn from work in other neurological conditions like spinal cord injury, is that AIH delivered before movement training may improve strength and walking. Whether this benefits people with MS is not yet known, which is the gap the study addresses.
MINT itself uses surface EMG sensors on the leg muscles to capture muscle activity, which then controls game-like tasks on a screen. Participants practice activating the correct muscles for walking while suppressing unwanted 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
- Triple (Participant, 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
- 否
入选标准
- •Diagnosis of clinically definite multiple sclerosis
- •Patient-Determined Disease Steps (PDDS) score between 3 and 6
- •Relapse-free for at least 6 months prior to enrollment
- •Age ≥ 18 years and ≤ 75 years
- •Resting oxygen saturation (SpO₂) ≥ 95% on room air
- •Systolic blood pressure between 85-140 mmHg and diastolic blood pressure between 55-90 mmHg
- •Modified Ashworth Scale (MAS) score ≤ 3 at the ankle and knee
- •Mini-Mental State Examination (MMSE) score ≥ 24
- •Ability to walk at least 10 meters with or without an assistive device
- •Ability to perform active ankle dorsiflexion and plantarflexion
排除标准
- •Uncontrolled hypertension or hypotension outside the required ranges
- •History of epilepsy or seizures
- •Uncontrolled pulmonary, cardiovascular, or orthopedic disease
- •Premorbid or ongoing major psychiatric illness (e.g., major depression, psychosis)
- •Other neurological disease (e.g., stroke, traumatic brain injury, peripheral neuropathy)
- •Illnesses with potential to cause brain injury
- •Frequent or severe unexplained headaches
- •Pregnancy
- •Implanted medical devices (e.g., pacemakers, intrathecal pumps, brain stimulators)
研究者
Milap Sandhu
Principal Investigator
Shirley Ryan AbilityLab