Clinical trial NCT03814460: Stroke and Assessment of Muscle Tone
Official title: Stroke and Myotonometer: Validity, Reliability and Discrimination Between the Mechanical and Sensory Component of Spasticity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Muscle Tone Abnormalities
Pain
Muscle Spasticity
Keywords: Topographical mapping
Muscle state of tension
Myotonometer
Pressure Pain Threshold
Muscle Thickness
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen Macarena
name: Hospitales Universitarios Virgen del Rocío
First posted: 2019-01-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with acute or chronic stroke will be recruited from large public hospitals. The control participants will be selected from the same population-based cohort

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


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.

Primary outcomes:
measure: Pressure Pain Threshold, assessed by Manual Pressure Algometry
timeFrame: One time assessment
measure: Muscle Tone Assessment, using the modified Tardieu Scale
timeFrame: One time assessment
Secondary outcomes:
measure: Muscle Stiffness, assessed by a myotonometer
timeFrame: One time assessment
measure: Muscle State of Tension (Muscle Tone), assessed by a myotonometer
timeFrame: One time assessment
measure: Muscle Thickness
timeFrame: One time assessment
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University of Sevilla
city: Seville
country: Spain
facility: Physiotherapy Department, University of Seville
Study officials:
affiliation: Physiotherapy Department, University of Sevilla, Spain
name: Isabel Garcia Bernal, PT
role: PRINCIPAL_INVESTIGATOR
References: