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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rachel A Kalvakota, OTD, OTR/L
- Número de teléfono: 1-312-238-3947
- Correo electrónico: rkalvakota@sralab.org
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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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Comparador falso: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Six-Minute Walk Test (6MWT)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ten-Meter Walk Test (10MWT)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Milap Sandhu, PT, PhD, Shirley Ryan Abilitylab
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Signos y Síntomas Respiratorios
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Esclerosis múltiple
- Hipoxia
- Esclerosis Múltiple Recurrente-Remitente
- Esclerosis Múltiple Crónica Progresiva
Otros números de identificación del estudio
- STU00225287
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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