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Идёт набор NCT06573658

Neurophysiological Changes After Perturbation-based Training in Older Adults

Без фазы С лечением Falling Community Dwelling Older Adults Postural Stability Brain Connectivity

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: Perturbation-based balance training (PBT), Walking exercise (control).
Кому может быть актуально
Состояния в реестре: Falling, Community Dwelling Older Adults, Postural Stability, Brain Connectivity. 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Short-term Neurophysiological Changes After a Perturbation-based Training in Community-dwelling Older Adults: A Pilot Study

Обзор

This is an assessor-blinded neurophysiological study. Participants will be randomly assigned to a perturbation-based training (PBT) or a walking (control) group. Changes in postural stability and neurophysiology in the brain following PBT compared to walking exercise without perturbation will be investigated.

Подробное описание

A total of 88 participants will be randomly assigned to two groups receiving perturbation-based training (PBT) or walking exercise without perturbation (control). Written informed consent will be obtained from participants prior to the baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenience sampling in the local community. Both groups will receive two sessions of treadmill walking at their comfortable speed. Perturbations will be induced during treadmill walking only for the PBT group. As informed from previous literature, two sessions of PBT could have improved postural stability for up to 1.5 years. Between-group differences in behavioural and MRI findings will be examined before and after training to identify training-induced changes in postural stability, brain structures, and functional connectivities. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.

Вмешательства

  • Поведенческое Perturbation-based balance training (PBT)
    It will be a two-session training with each session lasting for approximately an hour. Perturbations will be induced during treadmill walking. Participants will be instructed to recover their balance and continue walking after the perturbations.
  • Поведенческое Walking exercise (control)
    It will be a two-session training with each session lasting for approximately an hour. The same training duration and format will be used as the PBT group, except that no perturbations will be induced during the treadmill walking.

Первичные конечные точки

  • Gray matter density in arbitrary units by structural Magnetic Resonance Imaging [Срок оценки: pre-intervention, and within 1-week after the intervention]
  • Brain connectivity derived from the correlation between the Blood-oxygen-level-dependent (BOLD) signals from different brain regions in arbitrary units obtained during functional MRI [Срок оценки: pre-intervention, and within 1-week after the intervention]
Вторичные конечные точки (12)
  • Postural stability [Срок оценки: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • Number of laboratory-falls [Срок оценки: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • Number of real-life-falls [Срок оценки: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.]
  • Step time of the recovery steps in milliseconds (ms) [Срок оценки: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • Step length of the recovery steps in millimeters (mm) [Срок оценки: pre-intervention, within 1 week after intervention and 4 months after intervention]
  • Trunk angle [Срок оценки: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • Hip height in millimeters (mm) [Срок оценки: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • Responsive postural adjustment upon translation [Срок оценки: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • Responsive postural adjustment upon tilting [Срок оценки: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • Muscle activation onset latency in milliseconds [Срок оценки: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention]
  • Balance confidence [Срок оценки: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention, and at the last prospective fall follow-up]
  • Cognitive flexibility and executive function [Срок оценки: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention]

Критерии участия

Критерии включения

  • Aged ≥ 60 years old
  • Community-dwelling
  • Right-handed
  • Able to communicate effectively in Cantonese or Mandarin
  • Able to walk independently on level ground for ≥ 30 minutes
  • Abbreviated Mental Test (Hong Kong version) score ≥ 6

Критерии исключения

  • Metal implants (e.g. pacemaker, artificial cochlea)
  • Uncorrected vision or hearing impairment
  • Osteoporosis
  • Hip or knee replacement within the last year
  • Musculoskeletal, cardiovascular, mental, or neurological disorders (such as Parkinson's disease) which can affect MRI examination, balance control, or exercise participation.

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT06573658 · HSEARS20230928002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗