Skip to main content
OpenTrials
Completed

NCT Number: NCT03814460

Stroke and Assessment of Muscle Tone

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscle Tone Abnormalities Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Physiotherapy Department, University of Seville, Seville, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Assessment of Tone, Pain and Thickness

Diagnostic Test

Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness. The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Muscle Stiffness, assessed by a myotonometer

    Time frame: One time assessment

    The stiffness of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the so-called MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.

    Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.

  2. Muscle State of Tension (Muscle Tone), assessed by a myotonometer

    Time frame: One time assessment

    The tone of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.

    Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.

  3. Muscle Thickness

    Time frame: One time assessment

    The thickness of the assessed muscles will be evaluated using ecography. Muscle thickness will be assessed in one point corresponding to a myotendinous site and one point corresponding to a muscle belly location in both, the biceps brachii and gastrocnemius muscles.

    Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Hospital Universitario Virgen Macarena
  • Hospitales Universitarios Virgen del Rocío

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2019
Registry last updated
Sep 23, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.