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Набор скоро начнётся NCT07724093

Effects of Powered Hip Flexion Device in Persons With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis (MS) Relapsing Remitting

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: Powered Hip Flexion Orthosis (Hypershell X).
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis (MS) Relapsing Remitting. Базовые параметры: 18 лет — 80 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

The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series

Обзор

The purpose of this study is to assess the immediate effects of a commercially available non-FDA regulated powered hip flexion assist device (Hypershell X, Shenzhen, China) on walking ability in persons with MS. The main question it aims to answer is: Does a powered hip flexion device provide immediate improvements in walking ability over short distances for people with MS?

Подробное описание

Individuals with multiple sclerosis (MS) frequently experience problems with walking that may include difficulty with advancing the leg during the swing phase of gait which can lead to a loss of independence and a higher risk of falls. To improve walking ability in this population, devices such as ankle-foot orthoses (AFO) and functional electrical stimulation (FES) are commonly used. However, recent advances in technology and robotics have led to the development of affordable and commercially available battery powered exoskeletons marketed towards improving activities such as hiking, running and cycling. There is emerging but limited evidence that hip flexion-assisting devices can modify kinematics and muscle activity during gait in people with MS, with several small-scale studies showing tolerability and shifts toward more normal hip motion during walking. However, there are no studies on the use of new commercially available powered hip flexion assist devices. Therefore, the purpose of this case series is to assess the immediate effects on walking ability of a commercially available, non-FDA regulated, powered hip flexion assist device (Hypershell X, Shenzhen, China).

Вмешательства

  • Устройство Powered Hip Flexion Orthosis (Hypershell X)
    Participants will perform a series of 10 meters walks while wearing the hip flexion assist device under the following conditions. 1) No assistance (passive mode) 2) 25% power assistance 3) 50% power assistance 4) 75% power assistance During the trial subjects will wear motion sensors that provide the following gait parameters: speed, step and stride length, foot clearance, foot angle at heel strike, circumduction, single and double support time.

Первичные конечные точки

  • Gait speed [Срок оценки: Day 1 (immediate effect of device use)]
  • Foot clearance [Срок оценки: Day 1 (immediate effect of device use)]
Вторичные конечные точки (3)
  • Step length [Срок оценки: Day 1 (immediate effect of device use)]
  • Circumduction [Срок оценки: Day 1 (immediate effect of device use)]
  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) [Срок оценки: Day 1 (immediate effect of device use)]

Критерии участия

Критерии включения

  • Age 18-80
  • Diagnosis of relapsing remitting, primary progressive or secondary progressive MS
  • Unilateral or bilateral hip flexion weakness (Manual muscle testing score of 3 or less)
  • Ability to walk at least 30 meters without requiring rest and without physical support or assistance from another person.
  • Waist circumference 26-48", Height 5 '- 6'2", Weight 100-230lbs

Критерии исключения

  • Prior regular use of a hip flexion orthosis within the past 6 months.
  • Cognitive or communication deficits that would limit ability to participate safely.
  • Significant pain or deformity of the lower extremities that could impact walking ability.
  • Severe spasticity (Modified Ashworth Score of 3 or 4) of the hips or lower extremities that could impact walking ability.
  • Any other neurological conditions that may affect gait.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Dayton — Dayton

Идентификаторы

NCT: NCT07724093 · IRB-FY2026-240

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗