Differential Assessment of Hypertonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorChang Gung University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Musculoskeletal injuries on legs.
Osteoporosis.
Current musculoskeletal or joint injuries in the lower limbs.
History of central or peripheral neuromuscular diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous passive motion device (CPM) of ankle - fast
Procedure/SurgeryContinuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions
Continuous passive motion device (CPM) of ankle - slow
Procedure/SurgeryContinuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Healthy ParticipantsExperimental treatment 2 interventions
Group B: PD PatientsExperimental treatment 2 interventions
Group C: SCI PatientsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
H-reflex Amplitude
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 CPM2
M-wave Amplitude
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 CPM3
Level of Post-Activation Depression (PAD) of the H-reflex.
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 CPM4
H/M ratio
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 CPMSecondary outcomes
1
M-wave Latency
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
Before CPM, immediately after CPMOther outcomes
1
Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).
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
Baseline2
Overall the Parkinson's Disease Questionnaire-39 (PDQ-39) Score
An aggregated score derived from the eight dimension scores, providing a comprehensive measure of the individual's quality of life.
Time frame
Baseline3
Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score
: 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
Baseline4
Total The Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score
The sum of scores from all 14 items, providing an overall measure of motor impairment severity.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov