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Completed

NCT Number: NCT04266964

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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