Stroke and Assessment of Muscle Tone

NCT ID: NCT03814460

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-02
• Study Completion Date: 2019-08-25

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Assessment of Tone, Pain and Thickness

Intervention Type: 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

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

Assessment of Tone, Pain and Thickness

Intervention Type: 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

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.

Assessment of Tone, Pain and Thickness

Intervention Type: 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

Interventions

Assessment of Tone, Pain and Thickness

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role: collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role: collaborator

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Alberto Marcos Heredia-Rizo

Assistant Professor. Physiotherapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabel Garcia Bernal, PT

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Department, University of Sevilla, Spain

Locations

Physiotherapy Department, University of Seville

Seville, , Spain

University of Sevilla

Seville, , Spain

Countries

Spain

Other Identifiers

Myoton18

Identifier Type: -

Identifier Source: org_study_id