Incomplete Spinal Cord InjuryNCT06680063
Correlation Between Clinical Assessment and Neurophysiological Assessment in Spinal Cord Injury
An observational study of Incomplete Spinal Cord Injury and Spastic Tetraplegia, run by Mahidol University at 1 site in Thailand.
Trial summary
This study is a cross-sectional study that aims to explore the correlation between clinical assessment and neurophysiological assessment in SCI. The clinical outcome assessment are modified-Modified Ashworth scale (m-MAS) and lower extremity motor score. The neurophysiological outcome is H-reflex outcome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Incomplete Spinal Cord Injury, Spastic Tetraplegia, Spastic Paraplegia
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- 23 Aug 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spinal cord injury people from Sirindhorn National Medical Rehabilitation Institute (SNMRI)
Who may be able to join
- Individuals with any level of SCI with age between 18-70 years.
- Onset of injury between 1-30 month.
- Presentation of H-reflex.
Who cannot join
- Having history of other neurological disease e.g. stroke
- Absent of H-reflex.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a cross-sectional study that aims to explore the correlation between clinical assessment and neurophysiological assessment in SCI. The clinical outcome assessment are modified-Modified Ashworth scale (m-MAS) and lower extremity motor score. The neurophysiological outcome is H-reflex outcome.
Read the detailed description
Spinal cord injury (SCI) cause disruption of descending control pathway in spinal cord. The disruption of descending control induce impaired motor and sensory function below the level of injury, as well as the electrical signal from supraspinal pathway. During spinal shock phase, spinal motoneuron become hypoexcitability, as resulting in muscle hypotonicity or flaccidity in clinical manifestation. The spinal motoneuron gradually increase during sub-acute to chronic phase as resulting in development of spasticity in SCI. Development of spasticity is realted to increase of spinal motoneuron excitability, which shown in a decrease in H-reflex latency and increase in Hmax/Mmax ratio. A previous study shown a medium correlation between Hmax/Mmax ratio and MAS in SCI and stroke people. Moreover, the MAS shown a strong correlation with Fugle-meyer score in stroke people. However, it remains unclear in correlation between clinical outcome and neurophysiological outcome assessment of spasticity, and the correlation of spasticity and the motor function in SCI.
This study aims to explore the correlation between clinical assessment and neurophysiological assessment of spasticity in SCI.The clinical outcome assessment are modified-Modified Ashworth scale (m-MAS) and lower extremity motor score (LEMS). The lower extremity motor score is obtained from American Spinal Injury Association (ASIA) imapirement scale. The neurophysiological outcome assessment is H-reflex methode. All particiants who will participated into this study will be assessed the m-MAS, LEMS and H-reflex.
- Conditions
- Incomplete Spinal Cord Injury, Spastic Tetraplegia, Spastic Paraplegia, Spinal Cord Injury
- Keywords
- Spinal cord injury, H-reflex, Spasticity
- Medical subject headings
- Quadriplegia, Paraplegia, Spinal Cord Injuries, Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
modified-Modified Ashworth scale
The modified-Modified Ashworth scale is a clinical outcome to evaluate level of spasticity in neurological patient. The MAS consists of 6 grading scale, range from 0 to 5; (i) 0: no increase in muscle tone or normal, (ii) 1: slight increase in muscle tone, with a cathch and release or minimal resistance at the end of the range of motion, (iii) 4: slight increase in muscle tone, manifested as a cathch, followed by minimal resistance through the remainder (less than half) of the range of motion, (iv) 3: a marked increase in muscle tone throughout most of the range of motion, but affected parts still easily moved, (v) 4: considered increase in muscle tone, passive movement difficult, (vi) 4: affected parts rigid in flexion or extension.
Measured: 1 day
Lower extremity motor score
The lower extremity motor score (LEMS) is obtained from American Spinal Injury Association (ASIA) imapirment scale. The ASIA imapirment scale consists of motor, sensory and anorectal examination. This assessment is an standard assessment form for SCI. The lower extremity motor score assess 5 key lower extremity muscles. which are hip flexors, knee extensors, ankle plantar flexors, ankle dorsiflexors and long toe extensors. These 5 key muscles represent motor recovery throughout myotome of the body. Grading of this assessment range from 0 to 5, according to mannual muscle testing grading system.
Measured: 1 day
Soleus H-reflex
A most reliable are for assess spinal motoneuron excitability is soleus H-reflex. The stimulation electrode place over the popletial fossa to stimulate tibial nerve. Two disposal surface electrode place over 1/3 of lower leg which is over the soleus muscle. Data from the assessment are H-reflex latency, H-reflex amplitude, M-wave response amplitude.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start23 Aug 2024
- Primary completion30 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680063
- Sponsor's protocol ID
- MU-CIRB 2023/119.0504-1
- Status last verified
- Jun 2025
- First submitted
- 1 Oct 2024
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Clinical Assessment and Neurophysiological Assessment in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06680063
- Acronym / sponsor ID
- MU-CIRB 2023/119.0504-1
- Conditions
- Incomplete Spinal Cord Injury, Spastic Tetraplegia, Spastic Paraplegia, Spinal Cord Injury
- Keywords
- Spinal cord injury, H-reflex, Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 8 Nov 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.
This study is a cross-sectional study that aims to explore the correlation between clinical assessment and neurophysiological assessment in SCI. The clinical outcome assessment are modified-Modified Ashworth scale (m-MAS) and lower extremity motor score. The neurophysiological outcome is H-reflex outcome.
Detailed description
Spinal cord injury (SCI) cause disruption of descending control pathway in spinal cord. The disruption of descending control induce impaired motor and sensory function below the level of injury, as well as the electrical signal from supraspinal pathway. During spinal shock phase, spinal motoneuron become hypoexcitability, as resulting in muscle hypotonicity or flaccidity in clinical manifestation. The spinal motoneuron gradually increase during sub-acute to chronic phase as resulting in development of spasticity in SCI. Development of spasticity is realted to increase of spinal motoneuron excitability, which shown in a decrease in H-reflex latency and increase in Hmax/Mmax ratio. A previous study shown a medium correlation between Hmax/Mmax ratio and MAS in SCI and stroke people. Moreover, the MAS shown a strong correlation with Fugle-meyer score in stroke people. However, it remains unclear in correlation between clinical outcome and neurophysiological outcome assessment of spasticity, and the correlation of spasticity and the motor function in SCI.
This study aims to explore the correlation between clinical assessment and neurophysiological assessment of spasticity in SCI.The clinical outcome assessment are modified-Modified Ashworth scale (m-MAS) and lower extremity motor score (LEMS). The lower extremity motor score is obtained from American Spinal Injury Association (ASIA) imapirement scale. The neurophysiological outcome assessment is H-reflex methode. All particiants who will participated into this study will be assessed the m-MAS, LEMS and H-reflex.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal cord injury people from Sirindhorn National Medical Rehabilitation Institute (SNMRI)
Key inclusion criteria (3 listed)
- Individuals with any level of SCI with age between 18-70 years.
- Onset of injury between 1-30 month.
- Presentation of H-reflex.
Key exclusion criteria (2 listed)
- Having history of other neurological disease e.g. stroke
- Absent of H-reflex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modified-Modified Ashworth scale
Time frame: 1 day
The modified-Modified Ashworth scale is a clinical outcome to evaluate level of spasticity in neurological patient. The MAS consists of 6 grading scale, range from 0 to 5; (i) 0: no increase in muscle tone or normal, (ii) 1: slight increase in muscle tone, with a cathch and release or minimal resistance at the end of the range of motion, (iii) 4: slight increase in muscle tone, manifested as a cathch, followed by minimal resistance through the remainder (less than half) of the range of motion, (iv) 3: a marked increase in muscle tone throughout most of the range of motion, but affected parts still easily moved, (v) 4: considered increase in muscle tone, passive movement difficult, (vi) 4: affected parts rigid in flexion or extension.
Lower extremity motor score
Time frame: 1 day
The lower extremity motor score (LEMS) is obtained from American Spinal Injury Association (ASIA) imapirment scale. The ASIA imapirment scale consists of motor, sensory and anorectal examination. This assessment is an standard assessment form for SCI. The lower extremity motor score assess 5 key lower extremity muscles. which are hip flexors, knee extensors, ankle plantar flexors, ankle dorsiflexors and long toe extensors. These 5 key muscles represent motor recovery throughout myotome of the body. Grading of this assessment range from 0 to 5, according to mannual muscle testing grading system.
Soleus H-reflex
Time frame: 1 day
A most reliable are for assess spinal motoneuron excitability is soleus H-reflex. The stimulation electrode place over the popletial fossa to stimulate tibial nerve. Two disposal surface electrode place over 1/3 of lower leg which is over the soleus muscle. Data from the assessment are H-reflex latency, H-reflex amplitude, M-wave response amplitude.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incomplete Spinal Cord Injury and Spastic Tetraplegia, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jun 2025. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified-Modified Ashworth scale (time frame: 1 day). The study lists 3 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 25 Jun 2025.