Clinical trial NCT06680063: Correlation Between Clinical Assessment and Neurophysiological Assessment in Spinal Cord Injury
Official title: Correlation Between Clinical Assessment and Neurophysiological Assessment in Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Incomplete Spinal Cord Injury
Spastic Tetraplegia
Spastic Paraplegia
Spinal Cord Injury
Keywords: Spinal cord injury
H-reflex
Spasticity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Spinal cord injury people from Sirindhorn National Medical Rehabilitation Institute (SNMRI)

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Individuals with any level of SCI with age between 18-70 years.
* Onset of injury between 1-30 month.
* Presentation of H-reflex.

Exclusion Criteria:

* Having history of other neurological disease e.g. stroke
* Absent of H-reflex.

Primary outcomes:
measure: modified-Modified Ashworth scale
timeFrame: 1 day
measure: Lower extremity motor score
timeFrame: 1 day
measure: Soleus H-reflex
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nakhon Pathom
country: Thailand
facility: Mahidol University
state: Salaya
Study officials:
References: