Correlation Between Clinical Assessment and Neurophysiological Assessment in Spinal Cord Injury

NCT06680063 | Completed

• 1 other identifier: MU-CIRB 2023/119.0504-1
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Incomplete Spinal Cord Injury; Spastic Tetraplegia; Spastic Paraplegia; Spinal Cord Injury

Keywords

Spinal cord injury; H-reflex; Spasticity

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 day

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Spinal cord injury people from Sirindhorn National Medical Rehabilitation Institute (SNMRI)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol University

Nakhon Pathom, Salaya, 73170, Thailand

Location

MeSH Terms

Conditions

Quadriplegia; Paraplegia; Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: November 8, 2024
• Study Start: August 23, 2024
• Primary Completion: September 30, 2024
• Study Completion: January 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

TH (1)