Validity and Reliability Study of the Muscle Excitability Scale in Spinal Cord Injury Patients

Study Overview
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Brief Summary
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The aim of the study is to verify validity and reliability of the Muscle excitability scale (MES), which has been developed to access muscle susceptibility to spasms and/or clones as part of spastic motor behavior in spinal cord injured patients.

Detailed Description
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The muscle excitability scale (MES) is intended for patients after spinal cord injury. The objective is to evaluate a motor response (muscle spasms or clones) to a sensory or motor stimulus. A sensory stimulus is created by thumb and pointfinger compression of cutaneous tissue on the inside part of the middle thigh and calf. A motor stimulus is created by passive movement of the lower limb to flexion and extension. The MES grades from 0 to 4 reflect the muscle spastic or clonic tendency and the extent of this motor response (from isolated to generalized). Two investigators will examine a spastic motor behavior in 50 chronic SCI subjects using MES, Modificated Ashworth Scale (MAS) and Penn Spasms Frequency Scale (PSFS) to verify the validity and reliability of the MES.

Official Title
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Muscle Excitability Scale for Assessment of Spastic Reflexes in Spinal Cord Injury. Part II: Validity and Reliability Study

Conditions
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Spasticity, Muscle, Spinal Cord Injuries

Intervention / Treatment
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* Procedure: Manual examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spasticity in Spinal Cord Injury Exclusion Criteria: Parallel brain injury Cognitive deficit affecting cooperation Acute infection or other sudden complication Recent change of antispastic medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Manual examination|With the patient in a supine position, squeeze the skinfold between your thumb and pointfinger on the inner aspect of the middle third of the thigh and on the inner aspect of the middle third of the calf. Place your hand under the proximal calf and the heel and move the leg into maximum flexion at the hip and knee joints. After the response, if any, is completed, move the limb back into full extension. Each of these movements lasts for one second.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Excitability Scale | Scoring from 0 to 4; 0 = no motor response (muscle spasm or clonus) to a tactile stimulus or passive movement; 4 = generalized motor response to both a tactile stimulus and passive movement | through study completion, an average of 1 year | 
| Modified Ashworth Scale | Scoring from 0 to 4; 0 = no increase in muscle tone; 4 = affected part(s) rigid in flexion or extension | through study completion, an average of 1 year | 
| Penn Spasm Frequency Scale | Scoring 0 to 4; 0 = no spasms; 4 = spasms occurring more than 10 times per hour | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of validity and reliability index of Muscle Excitability Scale | To determine validity, inter-rater and intra-rater reliability of the Muscle Excitability Scale | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, Spinal cord injury, Validity, Reliability