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Идёт набор NCT06981013

Effects of Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without 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: balance based torso weighting.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Balance-based Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis

Обзор

Rationale: The Balance-Based Torso-Weighting (BBTW) is a patented evaluation system that uses strategic placement of small or lightweight weights on the trunk to improve balance and stability. BBTW has been found to improve the upright mobility of people with multiple sclerosis, however the mechanism underlying the improvement of balance and gait is still unknown.1-2 Purpose: The purpose of this study is to investigate the immediate effects of BBTW on muscle activation of tibialis anterior and gastrocsoleus and sway using electromyography and force plates during balance tests in people with MS and healthy controls?

Подробное описание

Research Questions:

Question #1 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes open? Question #2 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes closed? Question #3 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes open? Question #4 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes closed? Question #5 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes open? Question #6 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes closed? Question #7 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes open? Question #8 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes closed? Research Design: Quasi-experimental design

Вмешательства

  • Другое balance based torso weighting
    The intervention in this study is the Balance-Based-Torso-Weighting (BBTW) which will be applied on individuals with MS and healthy controls. It involves the strategic placement of weights based on the assessment of the loss of balance in three dimensions: anterior-posterior, lateral, rotational to counteract the balance loss.4 The BBTW Evaluation Tool Kit will be used to determine the location of the weights. It consists of an adjustable testing vest; rigid orthotic; five pounds worth of weight

Первичные конечные точки

  • Muscle Activation of B lateral gastrocnemius and tibialis anterior [Срок оценки: Baseline and study completion, after an average of three hours]
  • Postural Sway as measured by center of pressure displacement [Срок оценки: Baseline and study completion, after an average of three hours]

Критерии участия

Inclusion Criteria for Individuals with Multiple Sclerosis group:

  • self-reported diagnosis of multiple sclerosis (MS)
  • age 18 to 75 years old
  • able to communicate in English
  • able to provide informed consent
  • able to tolerate up to three hours of testing with rest breaks
  • able to walk 20 meters with or without assistive device and without resting (equivalent to Expanded Disability Status Scale of 6.5 or less).

Inclusion criteria for the Healthy Control group:

  • able to communicate in English
  • able to provide informed consent
  • physical criteria that matched each participant with MS which included age (within 7 years), height (within 12.7 cm \[5 in\]), mass (within 9.1 kg \[20 lb\]) and sex.

Exclusion Criteria for Individuals with Multiple Sclerosis group:

  • exacerbation of MS within the past two months
  • had a diagnosis of a concurrent neurological disorder (head injury, stroke, Parkinson's disease, etc.)
  • reported pain that could be exacerbated by external perturbations during standing.

Exclusion Criteria for Healthy control group:

  • Known diagnoses
  • current pain that could affect balance.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of St. Augustine for Health Sciences — Saint Augustine

Идентификаторы

NCT: NCT06981013 · 23-1101-275

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗