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临床试验/NCT06596187
NCT06596187招募中不适用

Differential Assessment of Hypertonia Related to CNS Impairment

Chang Gung University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
2
主要终点
Elasticity (Dynamic Stiffness, N/m)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Parkinson disease.

排除标准

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

结局指标

主要结局

Elasticity (Dynamic Stiffness, N/m)

时间窗: Before CPM, immediately after CPM

Elasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse

H-reflex Amplitude

时间窗: Before CPM, immediately after CPM

The peak-to-peak amplitude of the H-reflex measured in the soleus muscle to assess spinal motor neuron excitability. Unit: Millivolts (mV)

M-wave Amplitude

时间窗: Before CPM, immediately after CPM

The peak-to-peak amplitude of the M-wave recorded in the soleus muscle to assess peripheral motor neuron excitability and muscle response. Unit: Millivolts (mV)

Level of Post-Activation Depression (PAD) of the H-reflex.

时间窗: Before CPM, immediately after CPM

The H-reflex will be elicited by electrical stimulation of the tibial nerve (or other motor nerves), and PAD will be assessed by measuring the reduction in H-reflex amplitude following a series of repetitive stimuli. The amplitude of the H-reflex after repeated stimulation will be compared to the baseline single stimulus.

H/M ratio

时间窗: Before CPM, immediately after CPM

The H/M ratio is calculated by dividing the amplitude of the H-reflex by the amplitude of the M-wave.

Muscle Tone (Frequency, Hz)

时间窗: Before CPM, immediately after CPM

This parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness

Stiffness (Decay, ms)

时间窗: Before CPM, immediately after CPM

This parameter quantifies the rate at which the muscle returns to its initial state after the impulse, indicating the muscle's stiffness.

Mechanical Stress (Creep, s) and Relaxation (S)

时间窗: Before CPM, immediately after CPM

These parameters measure the time it takes for muscle tissue to adapt to a sustained force (creep) and the time it takes for the muscle to return to a relaxed state after removing the force (relaxation)

Plantar foot pressure distribution and peak pressure

时间窗: Measured continuously during CPM

Foot pressure will be measured using a pressure sensors during ankle movement.

次要结局

  • M-wave Latency(Before CPM, immediately after CPM)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Ju Chang

Professor

Chang Gung University

研究点 (2)

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