Stroke and Assessment of Muscle Tone

NCT03814460 | Completed DMC

• 1 other identifier: Myoton18
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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

Conditions

Stroke; Muscle Tone Abnormalities; Pain; Muscle Spasticity

Keywords

Topographical mapping; Muscle state of tension; Myotonometer; Pressure Pain Threshold; Muscle Thickness

Outcome Measures

Primary Outcomes (2)

• Pressure Pain Threshold, assessed by Manual Pressure Algometry

  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

  One time assessment

• Muscle Tone Assessment, using the modified Tardieu Scale

  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.

  One time assessment

Secondary Outcomes (3)

• Muscle Stiffness, assessed by a myotonometer

  One time assessment

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

  One time assessment

• Muscle Thickness

  One time assessment

Study Arms (3)

Control Group

A control group of healthy subjects with no previous history of neurological disorders or conditions. This group pf participants will be selected in a similar population based-cohort than the other two study groups.

Diagnostic Test: Assessment of Tone, Pain and Thickness

Acute Stroke Group

In this group, participants who suffered a previous stroke within 3 months before data collection will be included.

Diagnostic Test: Assessment of Tone, Pain and Thickness

Chronic Stroke Group

In this group, only participants who have suffered a previous stroke of more than 3 months duration before data collection will be included.

Diagnostic Test: Assessment of Tone, Pain and Thickness

Interventions

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

Acute Stroke Group; Chronic Stroke Group; Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead
• Hospital Universitario Virgen Macarena: collaborator
• Hospitales Universitarios Virgen del Rocío: collaborator

Study Sites (2)

Physiotherapy Department, University of Seville

Seville, 41009, Spain

Location

University of Sevilla

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Stroke; Pain; Muscle Spasticity

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Isabel Garcia Bernal, PT

  Physiotherapy Department, University of Sevilla, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor. Physiotherapy Department

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 24, 2019
• Study Start: February 2, 2019
• Primary Completion: August 25, 2019
• Study Completion: August 25, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

ES (2)