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Идёт набор NCT06543888

Effects of Passive Lower-limb Exoskeleton-assisted Training on Motor and Daily Function Improvements in Older Adults

Без фазы С лечением Multidomain Intervention

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: passive exoskeleton- assisted gait training programs, Conventional gait training.
Кому может быть актуально
Состояния в реестре: Multidomain Intervention. Базовые параметры: от 60 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

According to National Development Council estimation, Taiwan is about to enter a super-aged society in 2025, and health promotion for the elderly are critical issues nowadays. The age-related decline in motor function will further affect participation in activities of daily living. In addition to conventional rehabilitation training, robot-assisted training has gained acceptance in clinical rehabilitation. However, robot-assisted trainings were mostly used for motor recovery in patients with neurological disorders, and has not yet been applied to motor function training in community dwelling older adults. This study will examine the effect of passive exoskeleton-assisted gait training on motor function, daily function and self- efficacy in community dwelling older adults, so as to achieve health promotion and develop a new training approach. The purpose of this study will be to determine the comparative effects of passive exoskeleton-assisted gait training and conventional gait training on motor and daily function improvements in older adults.

Вмешательства

  • Поведенческое passive exoskeleton- assisted gait training programs
    Participants will wear an exoskeleton during the training. Each 30-minute Passive exoskeleton-assisted gait training session include range of motion exercise, movement facilitation, strengthening exercise, coordination exercise, and task-oriented training for activities of daily living
  • Поведенческое Conventional gait training
    Each 30-minute conventional gait training session include range of motion exercise, movement facilitation, strengthening exercise, coordination exercise, and task-oriented training for activities of daily living.

Первичные конечные точки

  • Change scores of Five Times Sit to Stand Test (FTSST) [Срок оценки: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]]
  • Change scores of Timed Up and Go Test (TUG) [Срок оценки: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]]
  • Change scores of 10-meter walk test (10MWT) [Срок оценки: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]]
  • Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL) [Срок оценки: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]]
  • Change scores of Daily Living Self-Efficacy Scale (DLSES) [Срок оценки: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]]
  • Change scores of Functional Abilities Confidence Scale (FACS) [Срок оценки: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]]
  • Change scores of Mini-Mental State Examination (MMSE) [Срок оценки: Baseline, post test after completing 12 intervention sessions (around 4 weeks after baseline), follow up test (1 month after completing intervention sessions)]]

Критерии участия

Критерии включения

  • age ≧ 60
  • normal functional range of motion (within functional limits) in trunk, and leg joints
  • ability to walk continuously for 10 minutes with or without an assistive device
  • Mini Mental State Exam (MMSE) score > 24, indicating no serious cognitive impairment

Критерии исключения

  • histories of neurological diseases such as dementia, Parkinson\'s disease, and peripheral polyneuropathy
  • recent lower leg injury (6 months) or surgery (1 year) based on self-report
  • taking any over-the-counter drugs, prescription medications, or any substance that may affect gait
  • difficulties in following and understanding instructions
  • enroll in other rehabilitation or drug studies simultaneously -

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Тайвань · 1 центр
  • Chang Gung Memotial Hospital — Taoyuan

Идентификаторы

NCT: NCT06543888 · 202302129B0

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗