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Clinical Trials/NCT03814460
NCT03814460
Completed
Not Applicable

Stroke and Myotonometer: Validity, Reliability and Discrimination Between the Mechanical and Sensory Component of Spasticity

University of Seville2 sites in 1 country65 target enrollmentFebruary 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Seville
Enrollment
65
Locations
2
Primary Endpoint
Muscle Tone Assessment, using the modified Tardieu Scale
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Spasticity is defined as a state of increased muscle tone, which evokes an increased resistance to a passive and fast stretching of the muscle. Indeed, the degree of spasticity depends, among other things, on the stretching velocity performed to the muscle. However, most of the tools used in the clinical setting to assess spasticity do not take into account the relationship between increased muscle tone and speed of stretching. Instead of that, muscle tone is usually assessed in a relaxed position of the muscle.

Likewise, to date, despite the functional disabilities related to the presence of chronic pain after a stroke, no previous study has correlated muscle tone and pressure pain sensitivity within this population

Registry
clinicaltrials.gov
Start Date
February 2, 2019
End Date
August 25, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alberto Marcos Heredia-Rizo

Assistant Professor. Physiotherapy Department

University of Seville

Eligibility Criteria

Inclusion Criteria

  • Be older than 18 years
  • Clinical diagnosis of stroke, confirmed using a MRI.
  • No previous history of other strokes.
  • Increases muscle tone in upper and lower extremities (punctuation equal to or superior to 1 in the Tardieu Scale, Ashworth Scale)
  • Ability to understand the study goals, follow simple instructions and provide informed consent.
  • Score equal to or superior to 24 in the Minimental State Examination.

Exclusion Criteria

  • Any other confirmed neurological disorder that may influence muscle tone (multiple sclerosis, Parkinson, muscle dystrophies...)
  • A chronic musculoskeletal disorder in the upper or lower limb.
  • Previous history of surgery in the upper or lower extremities.
  • Changes in the medication intake that may affect muscle tone assessments in the 48 hours before data collection.
  • Having received botulin toxin in gastrocnemius or biceps brachii muscles in the 30 days before data collection.
  • A concomitant acute infection during data collection.
  • A previous epileptic crisis in the week before the study or during the study.

Outcomes

Primary Outcomes

Muscle Tone Assessment, using the modified Tardieu Scale

Time Frame: One time assessment

The modified Tardieu Scale is the most common tool used in the clinical setting to evaluate the muscle tone. The muscle response to a slow and fast stretching will be performed. During the fast stretching, the joint angle in which the muscle responds with difficulty will be collected using an electrogoniometer.

Pressure Pain Threshold, assessed by Manual Pressure Algometry

Time Frame: One time assessment

A handheld electronic pressure algometer with a 1-cm2 contact probe will be used. Pressure pain thresholds (PPTs), as the minimum necessary pressure force to evoke pain, will be assessed bilaterally over biceps brachii and the gastrocnemius muscles (medial and lateral). Assessments will be made using a topographical mapping covering myotendinous and muscle belly sites in the above mentioned muscles. A 30-second break will be used between assessments to prevent bruising, and an average of the two measures over each site will be calculated for the statistical analysis. Pressure algometry is reliable in healthy individuals, and in stroke patients

Secondary Outcomes

  • Muscle State of Tension (Muscle Tone), assessed by a myotonometer(One time assessment)
  • Muscle Thickness(One time assessment)
  • Muscle Stiffness, assessed by a myotonometer(One time assessment)

Study Sites (2)

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