Not yet recruitingNot a drug-phase studyRelapsing and progressiveNCT07631923

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Acute Intermittent Hypoxia (AIH)
  • Myoelectric Interface Neurorehabilitation Training (MINT)

Placebo or sham

  • Sham Acute Intermittent Hypoxia (AIH)

What it measured

Main measures

  • Six-Minute Walk Test (6MWT)

    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 follo

    Walking and mobility

Other measures (5)

  • Ten-Meter Walk Test (10MWT)

    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)

    Walking and mobility
  • Stair Climb Test (SCT)

    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

    Walking and mobility
  • Maximal Voluntary Contraction (MVC) Testing

    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

    Physical function
  • Fatigability Testing

    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

    Fatigue
  • Ankle Proprioception Testing

    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

Who could take part

Relapsing and progressive · 18 to 75

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jun 2026

    2. Main results due

      Jan 2028

    3. Finished

      Jun 2028

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