Differential Assessment of Hypertonia

Differential Assessment of Hypertonia Related to CNS Impairment

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.

Study Overview

• Status: Recruiting
• Conditions: SCI - Spinal Cord Injury; PD - Parkinson's Disease
• Intervention / Treatment: Procedure: Continuous passive motion device (CPM) of ankle - fast; Procedure: Continuous passive motion device (CPM) of ankle - slow

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Ju Chang, PhD; Phone Number: 5515 +88632118800; Email: yjchang@mail.cgu.edu.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung University
    • Contact: Ya-Ju Chang, PhD; Phone Number: 5515 88632118800; Email: yjchang@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria

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

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

1. Musculoskeletal injuries on legs
2. Osteoporosis.
3. Any peripheral or central nervous system injury or disease patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Participants; To establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD).	Procedure: Continuous passive motion device (CPM) of ankle - fast; Continuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions; Other Names: fast CPM; Procedure: Continuous passive motion device (CPM) of ankle - slow; Continuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions; Other Names: slow CPM
Experimental: PD Patients; To establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD).	Procedure: Continuous passive motion device (CPM) of ankle - fast; Continuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions; Other Names: fast CPM; Procedure: Continuous passive motion device (CPM) of ankle - slow; Continuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions; Other Names: slow CPM
Experimental: SCI Patients; To establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD).	Procedure: Continuous passive motion device (CPM) of ankle - fast; Continuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions; Other Names: fast CPM; Procedure: Continuous passive motion device (CPM) of ankle - slow; Continuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions; Other Names: slow CPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before CPM, immediately after CPM
H/M ratio	The H/M ratio is calculated by dividing the amplitude of the H-reflex by the amplitude of the M-wave.	Before CPM, immediately after CPM
Muscle Tone (Frequency, Hz)	This parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness	Before CPM, immediately after CPM
Elasticity (Dynamic Stiffness, N/m)	Elasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse	Before CPM, immediately after CPM
Stiffness (Decay, ms)	This parameter quantifies the rate at which the muscle returns to its initial state after the impulse, indicating the muscle's stiffness.	Before CPM, immediately after CPM
Mechanical Stress (Creep, s) and Relaxation (S)	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)	Before CPM, immediately after CPM
Plantar foot pressure distribution and peak pressure	Foot pressure will be measured using a pressure sensors during ankle movement.	Measured continuously during CPM
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)	Before CPM, immediately after CPM
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)	Before CPM, immediately after CPM

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Before CPM, immediately after CPM

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Baseline
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)	Baseline

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Rigidity; Spasticity; Post activation depression; Passive motion device (CPM)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Trauma, Nervous System; Spinal Cord Diseases; Parkinson Disease; Spinal Cord Injuries
• Other Study ID Numbers: SCI_PD_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No