Skip to content

Differential Assessment of Hypertonia

Differential Assessment of Hypertonia Related to CNS Impairment

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06596187
Enrollment
45
Registered
2024-09-19
Start date
2024-10-09
Completion date
2026-08-31
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PD - Parkinson's Disease, SCI - Spinal Cord Injury

Keywords

Spasticity, Post activation depression, Passive motion device (CPM), Rigidity

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREContinuous passive motion device (CPM) of ankle - fast

Continuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions

PROCEDUREContinuous passive motion device (CPM) of ankle - slow

Continuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions

Sponsors

Chang Gung University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Health subjects:

Exclusion criteria

1. Musculoskeletal injuries on legs. 2. Osteoporosis. SCI subjects: Inclusion Criteria 1. Participants with chronic spinal cord injury, with injury duration greater than one year.

Design outcomes

Primary

MeasureTime frameDescription
Plantar foot pressure distribution and peak pressureMeasured continuously during CPMFoot pressure will be measured using a pressure sensors during ankle movement.
H/M ratioBefore CPM, immediately after CPMThe H/M ratio is calculated by dividing the amplitude of the H-reflex by the amplitude of the M-wave.
Muscle Tone (Frequency, Hz)Before CPM, immediately after CPMThis parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness
Elasticity (Dynamic Stiffness, N/m)Before CPM, immediately after CPMElasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse
Stiffness (Decay, ms)Before CPM, immediately after CPMThis 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)Before CPM, immediately after CPMThese 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)
H-reflex AmplitudeBefore CPM, immediately after CPMThe peak-to-peak amplitude of the H-reflex measured in the soleus muscle to assess spinal motor neuron excitability. Unit: Millivolts (mV)
M-wave AmplitudeBefore CPM, immediately after CPMThe 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.Before CPM, immediately after CPMThe 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.

Secondary

MeasureTime frameDescription
M-wave LatencyBefore CPM, immediately after CPMThe 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)

Other

MeasureTime frameDescription
Overall the Parkinson's Disease Questionnaire-39 (PDQ-39) ScoreBaselineAn aggregated score derived from the eight dimension scores, providing a comprehensive measure of the individual's quality of life.
Overall the Patient Reported Impact of Spasticity Measure(PRISM) ScoreBaseline: 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.
Total The Unified Parkinson's Disease Rating Scale (UPDRS) Part III ScoreBaselineThe sum of scores from all 14 items, providing an overall measure of motor impairment severity.
Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).BaselineMuscle 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)

Countries

Taiwan

Contacts

Primary ContactYa-Ju Chang, PhD
yjchang@mail.cgu.edu.tw+88632118800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026