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Идёт набор NCT06596187

Differential Assessment of Hypertonia

Без фазы С лечением SCI - Spinal Cord Injury PD - Parkinson's Disease

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: Continuous passive motion device (CPM) of ankle - fast, Continuous passive motion device (CPM) of ankle - slow.
Кому может быть актуально
Состояния в реестре: SCI - Spinal Cord Injury, PD - Parkinson's Disease. Базовые параметры: от 20 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 →
Официальное название

Differential Assessment of Hypertonia Related to CNS Impairment

Обзор

Spasticity and rigidity are common symptoms of central nervous system injuries, such as spinal cord injury and Parkinson's disease, and result in distinct patterns of increased resistance during passive joint movements. Spasticity is characterized by a velocity-dependent increase in stretch reflexes, accompanied by exaggerated tendon responses, while rigidity is marked by consistent resistance throughout the range of motion, traditionally considered independent of stretch velocity. However, recent studies suggest that rigidity may also be influenced by stretch velocity. This study aims to investigate muscle tone by examining spasticity, rigidity, and normal muscle function through neural and biomechanical changes. Standard clinical tools, such as the Modified Ashworth Scale and Unified Parkinson's Disease Rating Scale, along with additional assessments like the Myoton and Post-Activation Depression (PAD), will be employed.

Подробное описание

Spasticity and rigidity are common symptoms resulting from central nervous system injuries (e.g., spinal cord injury and Parkinson's disease). During passive joint movement, spasticity and rigidity manifest as two distinct patterns of increased resistance. Spasticity is a type of hypertonia characterized by a stretch reflex that increases with speed, accompanied by exaggerated tendon reflexes. Rigidity, on the other hand, is another form of hypertonia, where resistance increases during passive movement and remains consistent throughout the range of motion.

The degree of rigidity is traditionally considered independent of stretch velocity, which is one of the key differences from spasticity. However, recent studies have found that rigidity may also increase with stretch velocity. Despite attempts to distinguish different types of hypertonia based on stretch velocity, these efforts have largely been unsuccessful. Many factors influence muscle tone, which can be broadly categorized into changes in neural and biomechanical properties. The Modified Ashworth Scale and the Unified Parkinson's Disease Rating Scale are the most commonly used clinical tools for assessing spasticity and rigidity. Additionally, devices such as the Myoton or laboratory parameters like Post-Activation Depression (PAD) are also used for assessment.

Вмешательства

  • Процедура Continuous passive motion device (CPM) of ankle - fast
    Continuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions
  • Процедура Continuous passive motion device (CPM) of ankle - slow
    Continuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions

Первичные конечные точки

  • H-reflex Amplitude [Срок оценки: Before CPM, immediately after CPM]
  • M-wave Amplitude [Срок оценки: Before CPM, immediately after CPM]
  • Level of Post-Activation Depression (PAD) of the H-reflex. [Срок оценки: Before CPM, immediately after CPM]
  • H/M ratio [Срок оценки: Before CPM, immediately after CPM]
  • Muscle Tone (Frequency, Hz) [Срок оценки: Before CPM, immediately after CPM]
  • Elasticity (Dynamic Stiffness, N/m) [Срок оценки: Before CPM, immediately after CPM]
  • Stiffness (Decay, ms) [Срок оценки: Before CPM, immediately after CPM]
  • Mechanical Stress (Creep, s) and Relaxation (S) [Срок оценки: Before CPM, immediately after CPM]
  • Plantar foot pressure distribution and peak pressure [Срок оценки: Measured continuously during CPM]
Вторичные конечные точки (1)
  • M-wave Latency [Срок оценки: Before CPM, immediately after CPM]

Критерии участия

Health subjects:

Критерии исключения

  • Musculoskeletal injuries on legs.
  • Osteoporosis.

SCI subjects:

Inclusion Criteria 1. Participants with chronic spinal cord injury, with injury duration greater than one year.

Критерии исключения

  • Current musculoskeletal or joint injuries in the lower limbs.
  • History of central or peripheral neuromuscular diseases.
  • Presence of a pacemaker.
  • Current use of antispastic or antidepressant medications.
  • Current venous thromboembolism or osteoporosis.
  • Impairment of the soleus H-reflex arc.

PD subjects:

Критерии включения

\- Clinical diagnosis of Parkinson disease.

Критерии исключения

  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.

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
Фундаментальное исследование

Центры проведения

Тайвань · 1 центр
  • Chang Gung University — Taoyuan

Идентификаторы

NCT: NCT06596187 · SCI_PD_001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗