Chang Gung University
Taoyuan, 333, Taiwan
Location status: Recruiting
NCT Number: NCT06596187
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Taoyuan, 333, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Health subjects:
Exclusion criteria
SCI subjects:
Inclusion criteria
1. Participants with chronic spinal cord injury, with injury duration greater than one year.
Exclusion criteria
PD subjects:
Inclusion criteria
Exclusion criteria
Continuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions
Other names: fast CPM
Continuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions
Other names: slow CPM
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: Measured continuously during CPM
Foot pressure will be measured using a pressure sensors during ankle movement.
Time frame: Before CPM, immediately after CPM
The time from the onset of electrical stimulation to the onset of the M-wave response in the soleus muscle, used to assess changes in peripheral nerve conduction velocity. Unit: Milliseconds (ms)
Time frame: Baseline
Muscle spasticity levels will be assessed using the Modified Ashworth Scale (MAS), which evaluates resistance during passive soft-tissue stretching. This measure will be used to evaluate changes in muscle tone before and immediately after the intervention. Unit: MAS score (ordinal scale from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates rigidity in flexion or extension)
Time frame: Baseline
An aggregated score derived from the eight dimension scores, providing a comprehensive measure of the individual's quality of life.
Time frame: Baseline
: An aggregated score derived from all the individual items within the questionnaire, providing a comprehensive measure of the impact of spasticity on the patient's quality of life.
Time frame: Baseline
The sum of scores from all 14 items, providing an overall measure of motor impairment severity.
Contact information is provided by the study sponsor or research team.
Chang Gung University
Other
Differential Assessment of Hypertonia Related to CNS Impairment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05022095
Central Nervous System Diseases, Muscle Hypertonia
Nottwil, Canton of Lucerne, Switzerland
View Trial DetailsNCT07052344
Central Nervous System Diseases, Nervous System Diseases
Miami, Florida, United States
View Trial DetailsNCT06853015
Central Nervous System Diseases, Nervous System Diseases
Chicago, Illinois, United States
View Trial DetailsNCT05638191
Central Nervous System Diseases, Cervical Spinal Cord Injury
Vancouver, British Columbia, Canada
View Trial Details