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Идёт набор NCT06975059

Novel Shoe Device NUSHU to Measure Gait Analysis in Parkinson's Patients

Без фазы С лечением Parkinson's Disease (PD)

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: NUSHU shoe.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD). Базовые параметры: от 18 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

Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls

Обзор

Gait changes in Parkinson's disease are complex, variable, and difficult to detect during short clinic assessments. The aim of this study is to collect gait measurements in Parkinson's patients through sensors in a novel shoe device, NUSHU by Magnes AG. The shoe additionally provides vibrational feedback that can potentially help gait difficulties experienced by Parkinson's patients.

Вмешательства

  • Устройство NUSHU shoe
    The NUSHU shoe, created by Magnes AG, can measure real-time detection of gait analysis while providing vibrotactile stimulus to the study participant through machine learning sensors. This may provide a feedback mechanism that acts as therapy for gait difficulties.

Первичные конечные точки

  • Mean Score of Comfort Level of Device in Satisfaction Survey [Срок оценки: At Safety Follow Up (Week 18)]
  • Mean Score of Ease of Using Device in Satisfaction Survey [Срок оценки: At Safety Follow Up (Week 18)]
  • Ratio of Participants Who Completed Study to Total Number of Participants Enrolled [Срок оценки: Through study completion, 18 weeks]
Вторичные конечные точки (11)
  • Mean Change from Baseline to Week 12 in TUG test [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in FOG Questionnaire [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in MDS-UPDRS III [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stride Time [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stride Length [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Swing Time [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stance Time [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Velocity [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Cadence [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Swing Phase [Срок оценки: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stance Phase [Срок оценки: At Baseline and In 12 Weeks]

Критерии участия

Parkinson's Disease:

Критерии включения

  • Male or female ≥ 18 years of age.
  • A diagnosis of Parkinson's disease
  • Able to give written informed consent (as determined by the investigator)
  • Can converse in English and read and perform all study activities
  • Has willingness and ability to comply with study requirements

Критерии исключения

  • Diagnosis of an atypical parkinsonism syndrome, drug-induced parkinsonism, essential tremor, or other diagnoses that explain movement symptoms other than PD
  • A diagnosis of significant CNS disease other than PD such as stroke, multiple sclerosis, epilepsy
  • Persons with disorders other than PD significantly affecting gait as determined by the investigator
  • History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator
  • Inability to wear interventional device
  • Unable to ambulate independently at least with assistive walking device but without additional person assistance
  • Pregnant or planning pregnancy within study timeframe
  • Montreal Cognitive Assessment (MoCA) score < 22 at screening
  • Resides in a nursing home or assisted care facility

Healthy Controls:

Критерии включения

  • Male or female ≥ 18 years of age.
  • No neurological disease or other significant gait impairment as deemed by the study investigator

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
  • Weill Cornell — New York

Идентификаторы

NCT: NCT06975059 · 24-05027451

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗