Acute Intermittent Hypoxia Combined With Gait Training in Multiple Sclerosis (MINT)
Acute Intermittent Hypoxia (AIH) Primed Myoelectric Interface Neurorehabilitation Training (MINT) for Gait Recovery in Multiple Sclerosis
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Rachel A Kalvakota, OTD, OTR/L
- 电话号码：1-312-238-3947
- 邮箱：rkalvakota@sralab.org
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：AIH + MINT
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During AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention.
The AIH intervention involves alternating breathing cycles.
One cycle involves breathing air with lower oxygen concentration (9-10% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration.
This cycle is repeated 15 times in one session.
Blood oxygen and heart rate are monitored throughout.
MINT is a gamified rehabilitation paradigm that uses surface electromyography (sEMG) biofeedback to retrain lower-limb muscle activation patterns. The intervention is designed to reduce abnormal coactivation of agonist-antagonist muscle pairs and facilitate more efficient torque generation during functional movements. sEMG electrodes will be placed bilaterally over the tibialis anterior, gastrocnemius, and quadriceps muscles. EMG signals will be acquired in real time, processed, and used to control on-screen tasks within a custom Unity-based software environment. Participants will engage in interactive tasks where selective activation of target muscles allows them to move a virtual avatar, align a gauge, or achieve movement goals while minimizing antagonist activity. Each MINT session will last approximately 60 minutes and will be delivered immediately following AIH or sham exposure. Sessions will include calibration of EMG channels, a brief familiarization period, and four to five tra |
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假比较器：SHAM AIH + MINT
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MINT is a gamified rehabilitation paradigm that uses surface electromyography (sEMG) biofeedback to retrain lower-limb muscle activation patterns. The intervention is designed to reduce abnormal coactivation of agonist-antagonist muscle pairs and facilitate more efficient torque generation during functional movements. sEMG electrodes will be placed bilaterally over the tibialis anterior, gastrocnemius, and quadriceps muscles. EMG signals will be acquired in real time, processed, and used to control on-screen tasks within a custom Unity-based software environment. Participants will engage in interactive tasks where selective activation of target muscles allows them to move a virtual avatar, align a gauge, or achieve movement goals while minimizing antagonist activity. Each MINT session will last approximately 60 minutes and will be delivered immediately following AIH or sham exposure. Sessions will include calibration of EMG channels, a brief familiarization period, and four to five tra
During Sham AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention.
The Sham AIH intervention involves alternating breathing cycles.
One cycle involves breathing air closely resembling room air (~21% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration.
This cycle is repeated 15 times in one session.
Blood oxygen and heart rate are monitored throughout.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Six-Minute Walk Test (6MWT)
大体时间：Change in distance (meters) from pre-training assessment (Day 1, before the first intervention) to Immediate Post (Day 5, after the final intervention), 1-week follow-up (Day 14-21), and 1-month follow-up (Day 36-41).
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Participants walk as far as they safely can in six minutes along a marked course, and total distance (meters) is recorded.
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Change in distance (meters) from pre-training assessment (Day 1, before the first intervention) to Immediate Post (Day 5, after the final intervention), 1-week follow-up (Day 14-21), and 1-month follow-up (Day 36-41).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ten-Meter Walk Test (10MWT)
大体时间：Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), with retention assessed at the 1-week (Day 14 to 21) and 1-month (Day 36 to 41)
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Measures gait speed over 10 meters at a self-selected comfortable pace, averaged across two trials.
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Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), with retention assessed at the 1-week (Day 14 to 21) and 1-month (Day 36 to 41)
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Stair Climb Test (SCT)
大体时间：Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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Assesses functional mobility and lower-limb power.
Participants ascend a standardized 12-step staircase (17 cm per step, 2.04 m total) as quickly and safely as possible across three trials, with ascent time recorded and handrail use documented.
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Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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Maximal Voluntary Contraction (MVC) Testing
大体时间：Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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Measures maximal strength of the trained leg on a Biodex dynamometer across ankle plantarflexion, dorsiflexion, knee flexion, and knee extension.
Participants perform 3 to 5 maximal isometric contractions (10 seconds each) per movement while surface EMG quantifies agonist activation and antagonist coactivation.
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Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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Fatigability Testing
大体时间：Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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Quantifies muscle fatigue as the percent decline in torque across 20 consecutive maximal isometric plantarflexion contractions (5 to 10 seconds each) on the Biodex, with surface EMG monitoring changes in activation and coactivation through the series.
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Baseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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Ankle Proprioception Testing
大体时间：aseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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Assesses joint sense on the trained leg via the Biodex while the participant is blindfolded with noise-cancelling headphones.
It includes a movement detection threshold (trigger press when slow passive rotation is first felt, 5 to 6 trials) and joint position matching (reproducing a passively set target angle, 6 to 8 trials), with surface EMG confirming no compensatory activity.
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aseline/pre-training (Day 1) to immediately post-intervention (Day 5), then 1-week (Day 14 to 21) and 1-month (Day 36 to 41) follow-ups
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合作者和调查者
调查人员
- 首席研究员：Milap Sandhu, PT, PhD、Shirley Ryan Abilitylab
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STU00225287
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