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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266964
• Other study ID #: SCI_MES_2019
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: February 25, 2023

Study information

• Verified date: March 2023
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 25, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Czechia	Department of Rehabilitation and Sports Medicine, University Hospital Motol	Prague
Czechia	Paraple Center - rehab center for SCI people	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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