SCI - Spinal Cord InjuryNCT06596187
Differential Assessment of Hypertonia
A study testing Continuous passive motion device (CPM) of ankle - fast and Continuous passive motion device (CPM) of ankle - slow in people with SCI - Spinal Cord Injury and PD - Parkinson's Disease, run by Chang Gung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury, PD - Parkinson's Disease
- What is being tested?
- Continuous passive motion device (CPM) of ankle - fast and Continuous passive motion device (CPM) of ankle - slow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Oct 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease.
Who cannot join
- Musculoskeletal injuries on legs.
- Osteoporosis.
- SCI subjects:
- Inclusion Criteria 1. Participants with chronic spinal cord injury, with injury duration greater than one year.
- Current musculoskeletal or joint injuries in the lower limbs.
- History of central or peripheral neuromuscular diseases.
Show all 14Show fewer
- 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:
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- SCI - Spinal Cord Injury, PD - Parkinson's Disease
- Being tested
- Continuous passive motion device (CPM) of ankle - fast, Continuous passive motion device (CPM) of ankle - slow
- Keywords
- Spasticity, Post activation depression, Passive motion device (CPM), Rigidity
- Medical subject headings
- Spinal Cord Injuries, Parkinson Disease, Muscle Spasticity, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous passive motion device (CPM) of ankle - fastProcedure or surgery
Also called fast CPM
Continuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions
Continuous passive motion device (CPM) of ankle - slowProcedure or surgery
Also called slow CPM
Continuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | To establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD). Receives: 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). Receives: 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). Receives: Procedure: Continuous passive motion device (CPM) of ankle - fast; Procedure: Continuous passive motion device (CPM) of ankle - slow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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: Measured continuously during CPM
Secondary 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)
Measured: Before CPM, immediately after CPM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596187
- Sponsor's protocol ID
- SCI_PD_001
- Status last verified
- Oct 2024
- First submitted
- 6 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Assessment of Hypertonia Related to CNS Impairment
- ClinicalTrials.gov ID
- NCT06596187
- Acronym / sponsor ID
- SCI_PD_001
- Conditions
- SCI - Spinal Cord Injury, PD - Parkinson's Disease
- Keywords
- Spasticity, Post activation depression, Passive motion device (CPM), Rigidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Procedure: Continuous passive motion device (CPM) of ankle - fast, Procedure: Continuous passive motion device (CPM) of ankle - slowTo establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD). |
| PD Patients | Experimental | Procedure: Continuous passive motion device (CPM) of ankle - fast, Procedure: Continuous passive motion device (CPM) of ankle - slowTo establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD). |
| SCI Patients | Experimental | Procedure: Continuous passive motion device (CPM) of ankle - fast, Procedure: Continuous passive motion device (CPM) of ankle - slowTo establish the relationship between changes in foot pressure during ankle joint movement, muscle tone, and Post-Activation Depression (PAD). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson disease.
Key exclusion criteria (14 listed)
- Musculoskeletal injuries on legs.
- Osteoporosis.
- Inclusion Criteria 1. Participants with chronic spinal cord injury, with injury duration greater than one year.
- Current musculoskeletal or joint injuries in the lower limbs.
- History of central or peripheral neuromuscular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous passive motion device (CPM) of ankle - fastAlso: fast CPMContinuous passive motion device (CPM) of ankle at 1HZ(60rpm) for 10 repetitions | Procedure or surgery | Healthy Participants, PD Patients, SCI Patients |
| Continuous passive motion device (CPM) of ankle - slowAlso: slow CPMContinuous passive motion device (CPM) of ankle 0.25HZ (15rpm) for 10 repetitions | Procedure or surgery | Healthy Participants, PD Patients, SCI Patients |
Primary outcome
H-reflex Amplitude
Time frame: Before CPM, immediately after CPM
The peak-to-peak amplitude of the H-reflex measured in the soleus muscle to assess spinal motor neuron excitability. Unit: Millivolts (mV)
M-wave Amplitude
Time frame: Before CPM, immediately after CPM
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)
Level of Post-Activation Depression (PAD) of the H-reflex.
Time frame: Before CPM, immediately after CPM
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.
H/M ratio
Time frame: Before CPM, immediately after CPM
The H/M ratio is calculated by dividing the amplitude of the H-reflex by the amplitude of the M-wave.
Muscle Tone (Frequency, Hz)
Time frame: Before CPM, immediately after CPM
This 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)
Time frame: Before CPM, immediately after CPM
Elasticity, 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)
Time frame: Before CPM, immediately after CPM
This 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)
Time frame: Before CPM, immediately after CPM
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)
Plantar foot pressure distribution and peak pressure
Time frame: Measured continuously during CPM
Foot pressure will be measured using a pressure sensors during ankle movement.
1 secondary outcome
M-wave Latency
Time frame: Before CPM, immediately after CPM
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous passive motion device (CPM) of ankle - fast and Continuous passive motion device (CPM) of ankle - slow in people with SCI - Spinal Cord Injury and PD - Parkinson's Disease, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ju Chang, PhD (+88632118800 ext. 5515, yjchang@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H-reflex Amplitude (time frame: Before CPM, immediately after CPM). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.