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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04266964
Enrollment
50
Registered
2020-02-12
Start date
2020-01-02
Completion date
2023-02-25
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity, Muscle, Spinal Cord Injuries

Keywords

Spasticity, Spinal cord injury, Validity, Reliability

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.

Interventions

PROCEDUREManual 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.

Sponsors

University Hospital, Motol
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle Excitability Scalethrough study completion, an average of 1 yearScoring 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 Scalethrough study completion, an average of 1 yearScoring from 0 to 4; 0 = no increase in muscle tone; 4 = affected part(s) rigid in flexion or extension
Penn Spasm Frequency Scalethrough study completion, an average of 1 yearScoring 0 to 4; 0 = no spasms; 4 = spasms occurring more than 10 times per hour

Secondary

MeasureTime frameDescription
Calculation of validity and reliability index of Muscle Excitability Scalethrough study completion, an average of 1 yearTo determine validity, inter-rater and intra-rater reliability of the Muscle Excitability Scale

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026