ClinicalTrials.Veeva

Menu

Differential Assessment of Hypertonia

C

Chang Gung University

Status

Enrolling

Conditions

SCI - Spinal Cord Injury
PD - Parkinson's Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06596187
SCI_PD_001

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

Healthy Participants
Experimental group
Description:
To establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD).
Treatment:
Procedure: Continuous passive motion device (CPM) of ankle - fast
Procedure: Continuous passive motion device (CPM) of ankle - slow
PD Patients
Experimental group
Description:
To establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD).
Treatment:
Procedure: Continuous passive motion device (CPM) of ankle - fast
Procedure: Continuous passive motion device (CPM) of ankle - slow
SCI Patients
Experimental group
Description:
To establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD).
Treatment:
Procedure: Continuous passive motion device (CPM) of ankle - fast
Procedure: Continuous passive motion device (CPM) of ankle - slow

Trial contacts and locations

1

Loading...

Central trial contact

Ya-Ju Chang, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems