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Идёт набор NCT05964829

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Chronic Progressive

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cionic Neural Sleeve NS-100, Walking Program.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive. Базовые параметры: 22 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis

Обзор

The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).

Подробное описание

The randomized within-participants crossover 12-week study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS.

Physical measurements, performance-based tests, and questionnaire responses will be recorded. These include physical activity recorded by the Cionic Neural Sleeve; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of MS.

All participants will be assigned a Cionic Neural Sleeve on the most impacted leg for 6 weeks, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Cionic Neural Sleeve will be worn for 6 weeks of the study while following the walking program.

Participants will be randomized to one of two groups: A or B. Group A will follow the walking program and wear the Neural Sleeve to receive stimulation assisted walking from the Neural Sleeve for 6 weeks. Group B will follow the walking program for 6 weeks. After 6 weeks, participants in each group will cross over to the other group.

Вмешательства

  • Устройство Cionic Neural Sleeve NS-100
    The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.
  • Поведенческое Walking Program
    15 minutes of walking for 5 days per week for 6 weeks

Первичные конечные точки

  • Change in Gait Speed [Срок оценки: Day 0, Week 6, Week 12]
  • Change in Perceived Walking Ability [Срок оценки: Day 0, Week 6, Week 12]
  • Change in MS Disability [Срок оценки: Day 0, Week 6, Week 12]
  • Amount of Daily Walking/Activity Level [Срок оценки: During allocation to receive the functional electrical stimulation arm]
  • Duration of Daily Walking/Activity Level [Срок оценки: During allocation to receive the functional electrical stimulation arm]

Критерии участия

Критерии включения

  • Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75
  • Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device
  • Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS) to identify persons with dementia
  • Able to tolerate the Neural Sleeve device for up to 8 hours per day
  • T25FWT time between 8 and 45 seconds
  • No recent change in medication or recent exacerbation of symptoms over the last 60 days
  • Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5

Критерии исключения

  • Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
  • Absent sensation in the impacted or more impacted leg
  • Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation
  • Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
  • History of falls greater than once a week
  • No use of FES devices in the past year
  • Demand-type cardiac pacemaker or defibrillator
  • Malignant tumor in the impacted or more impacted leg
  • Existing thrombosis in the impacted or more impacted leg
  • Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Cleveland State University — Cleveland

Идентификаторы

NCT: NCT05964829 · CIONIC-06-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗