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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 31, 2023

Detailed Description

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Muscle Excitability Scale
    • Time Frame: through study completion, an average of 1 year
    • 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
  • Modified Ashworth Scale
    • Time Frame: through study completion, an average of 1 year
    • Scoring from 0 to 4; 0 = no increase in muscle tone; 4 = affected part(s) rigid in flexion or extension
  • Penn Spasm Frequency Scale
    • Time Frame: through study completion, an average of 1 year
    • Scoring 0 to 4; 0 = no spasms; 4 = spasms occurring more than 10 times per hour

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Motol
  • Provider of Information About this Clinical Study
    • Principal Investigator: Assoc. Prof. Jiri Kriz, MD, PhD, Clinical Professor – University Hospital, Motol
  • Overall Official(s)
    • Jiri Kriz, MD, PhD, Principal Investigator, Spinal Cord Unit, University Hospital, Motol

References

Kriz J, Hlinkova Z. Muscle excitability scale – a novel tool for evaluation of spastic motor behaviors in spinal cord injury patients. In: Proceedings from the 55th ISCoS Annual Scientific Meeting; September 14-16, 2016; Vienna, Austria. Abstract 186.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.