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Clinical Trials/NCT04266964
NCT04266964
Completed
Not Applicable

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

University Hospital, Motol2 sites in 1 country50 target enrollmentJanuary 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spasticity, Muscle
Sponsor
University Hospital, Motol
Enrollment
50
Locations
2
Primary Endpoint
Muscle Excitability Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2020
End Date
February 25, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Motol
Responsible Party
Principal Investigator
Principal Investigator

Assoc. Prof. Jiri Kriz, MD, PhD

Clinical Professor

University Hospital, Motol

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Calculation of validity and reliability index of Muscle Excitability Scale(through study completion, an average of 1 year)

Study Sites (2)

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