Differential Assessment of Hypertonia

NCT06596187 | Recruiting

• 1 other identifier: SCI_PD_001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (1)

• M-wave Latency

  Before CPM, immediately after CPM

Other Outcomes (4)

• Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).

  Baseline

• Overall the Parkinson's Disease Questionnaire-39 (PDQ-39) Score

  Baseline

• Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score

  Baseline

Study Arms (3)

Healthy Participants

EXPERIMENTAL

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; Procedure: Continuous passive motion device (CPM) of ankle - slow

PD Patients

EXPERIMENTAL

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; Procedure: Continuous passive motion device (CPM) of ankle - slow

SCI Patients

EXPERIMENTAL

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; Procedure: Continuous passive motion device (CPM) of ankle - slow

Interventions

Continuous passive motion device (CPM) of ankle - fast PROCEDURE

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

Also known as: fast CPM

Healthy Participants; PD Patients; SCI Patients

Continuous passive motion device (CPM) of ankle - slow PROCEDURE

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

Also known as: slow CPM

Healthy Participants; PD Patients; SCI Patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Musculoskeletal injuries on legs.
• Osteoporosis.
• SCI subjects:
• Current musculoskeletal or joint injuries in the lower limbs.
• History of central or peripheral neuromuscular diseases.
• Presence of a pacemaker.
• Current use of antispastic or antidepressant medications.
• Current venous thromboembolism or osteoporosis.
• Impairment of the soleus H-reflex arc.
• PD subjects:
• \- Clinical diagnosis of Parkinson disease.
• Musculoskeletal injuries on legs
• Osteoporosis.
• Any peripheral or central nervous system injury or disease patients.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Parkinson Disease; Muscle Spasticity; Muscle Rigidity

Interventions

carboxypeptidase M

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ya-Ju Chang, PhD

CONTACT

+88632118800; yjchang@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

TW (1)