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Набор скоро начнётся NCT06712342

Effects of Upper Extremity-Focused Neuromuscular Training in People With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis

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: Neuromuscular Exercise Training, Conventional Exercise Training.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 64 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Upper Extremity-Focused Neuromuscular Exercise Training on Physical and Cognitive Functions in People With Multiple Sclerosis (NExTUp)

Обзор

The effectiveness of upper extremity focused neuromuscular exercise training in early stage people with MS will be investigated. People with MS enrolled in the study will be randomly assigned to three groups: Neuromuscular Exercise Group (NEG), Conventional Exercise Group (CEG), and Control Group (CG). All three groups will be assessed with primary and secondary outcome measures at baseline, week 8, and week 12. NEG, CEG, and CG will be initially assessed for upper extremity function, cognitive function, lower extremity function, grip strength, proximal muscle strength, sensation, coordination, fatigue, postural sway, and core muscle strength and endurance. Then, NEG will receive clinically supervised upper extremity focused neuromuscular exercise training with a minimum of 60 minutes of session time, 2 days a week for 8 weeks. This exercise training includes steps for postural control, weight transfer, proximal and distal muscle strengthening, proprioception, coordination and reaction speed. Similarly, CEG will receive clinically supervised traditional upper extremity exercise training, twice a week for 8 weeks, with a minimum of 60 minutes of session time. This exercise training includes strengthening with the band and manuel dexterity exercises. In both groups, stretching and mobility exercises will be added to the warm-up and cool-down exercises before and after the program. During this process, CG will be on the waiting list. At the end of 8 weeks, all three groups will be re-evaluated. After the exercise training, follow-up will be done and evaluations will be repeated in the 12th week. This study will provide evidence on the effects of upper extremity-focused neuromuscular exercise training on physical and cognitive functions in early-stage people with MS compared to traditional treatment approaches.

Вмешательства

  • Другое Neuromuscular Exercise Training
    This group will receive neuromuscular exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks. Warm-up Program - 5 minutes Postural Control-Weight Transfer - 10-15 minutes Strength Training - 30-35 minutes Proprioception - Coordination - Reaction Speed 10-15 minutes Cool-down Program - 5 minutes
  • Другое Conventional Exercise Training
    This group will be given traditional strength exercise training consisting of 60-75 minute sessions per day, 2 days per week for 8 weeks. Warm-up Program - 5 minutes Strength Training - 30-35 minutes Manuel Dexterity - 15-20 minutes Cool-down Program - 5 minutes

Первичные конечные точки

  • Nine Hole Peg Test [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Minnesota Manual Dexterity Test [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Manual Ability Measure-36 [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Timed 25-Foot Walk [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Symbol Digit Modalities Test [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Hand Dynamometer [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
Вторичные конечные точки (7)
  • Hand Held Dynamometer [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Biodex Balance System [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Laser-pointer Assisted Angle Reproduction Test [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Finger Tapping Test [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Fatigue Severity Scale [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Plank [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]
  • Curl-up [Срок оценки: At the beginning, at the end of 8 weeks and 12 weeks]

Критерии участия

Критерии включения

  • Definite MS according to McDonald criteria,
  • 18-64 years
  • RRMS,
  • EDSS < 4,
  • Minimal or moderate upper extremity involvement

Критерии исключения

  • Having an attack in the last three months,
  • Mini Mental Test <24 or visual deficit,
  • Other medical conditions accompanying MS (cardiac, orthopedic or rheumatic, etc.),
  • Being pregnant or breastfeeding,
  • Doing regular exercise - receiving physiotherapy,
  • Having spasticity of 2 or more in the upper extremity

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06712342 · 2024/125

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗