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

NCT04266964 | Completed

• 1 other identifier: SCI_MES_2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Spasticity, Muscle; Spinal Cord Injuries

Keywords

Spasticity; Spinal cord injury; Validity; Reliability

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Calculation of validity and reliability index of Muscle Excitability Scale

  through study completion, an average of 1 year

Interventions

Manual examination PROCEDURE

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.

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

Spasticity in spinal cord injury

You may qualify if:

• Spasticity in Spinal Cord Injury

You may not qualify if:

• Parallel brain injury
• Cognitive deficit affecting cooperation
• Acute infection or other sudden complication
• Recent change of antispastic medication

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (2)

Department of Rehabilitation and Sports Medicine, University Hospital Motol

Prague, 150 06, Czechia

Location

Paraple Center - rehab center for SCI people

Prague, 150 06, Czechia

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; 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

Study Officials

• Jiri Kriz, MD, PhD

  Spinal Cord Unit, University Hospital, Motol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 12, 2020
• Study Start: January 2, 2020
• Primary Completion: January 31, 2023
• Study Completion: February 25, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CZ (2)