StrokeNCT03814460
Stroke and Assessment of Muscle Tone
An observational study of Stroke and Muscle Tone Abnormalities, run by University of Seville at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Muscle Tone Abnormalities, Pain
- What is being tested?
- Assessment of Tone, Pain and Thickness
- How many people
- 65 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Feb 2019to 25 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Physiotherapy Department, University of Seville
Seville, 41009
University of Sevilla
Seville, 41009
About this study
Official title: Stroke and Myotonometer: Validity, Reliability and Discrimination Between the Mechanical and Sensory Component of Spasticity
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
- Being tested
- Assessment of Tone, Pain and Thickness
- Keywords
- Topographical mapping, Muscle state of tension, Myotonometer, Pressure Pain Threshold, Muscle Thickness
- Medical subject headings
- Stroke, Pain, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Tone, Pain and ThicknessDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Assessment of Tone, Pain and Thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: One time assessment
Secondary outcomes (3)
Muscle Stiffness, assessed by a myotonometer
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.
Measured: One time assessment
Muscle State of Tension (Muscle Tone), assessed by a myotonometer
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.
Measured: One time assessment
Muscle Thickness
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.
Measured: One time assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start2 Feb 2019
- Primary completion25 Aug 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, Hospitales Universitarios Virgen del Rocío
- Responsible party
- Principal investigator, Alberto Marcos Heredia-Rizo, University of Seville
- Investigators
- Isabel Garcia Bernal, PT, Principal investigator, Physiotherapy Department, University of Sevilla, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814460
- Sponsor's protocol ID
- Myoton18
- Status last verified
- Sep 2019
- First submitted
- 21 Jan 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke and Myotonometer: Validity, Reliability and Discrimination Between the Mechanical and Sensory Component of Spasticity
- ClinicalTrials.gov ID
- NCT03814460
- Acronym / sponsor ID
- Myoton18
- Conditions
- Stroke, Muscle Tone Abnormalities, Pain, Muscle Spasticity
- Keywords
- Topographical mapping, Muscle state of tension, Myotonometer, Pressure Pain Threshold, Muscle Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, Hospitales Universitarios Virgen del Rocío
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: Assessment of Tone, Pain and ThicknessA 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. |
| Acute Stroke Group | – | Diagnostic Test: Assessment of Tone, Pain and ThicknessIn this group, participants who suffered a previous stroke within 3 months before data collection will be included. |
| Chronic Stroke Group | – | Diagnostic Test: Assessment of Tone, Pain and ThicknessIn this group, only participants who have suffered a previous stroke of more than 3 months duration before data collection will be included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Tone, Pain and ThicknessEvaluation 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 | Diagnostic test | Acute Stroke Group, Chronic Stroke Group, Control Group |
Primary outcome
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
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.
3 secondary outcomes
Muscle Stiffness, assessed by a myotonometer
Time frame: One time assessment
Muscle State of Tension (Muscle Tone), assessed by a myotonometer
Time frame: One time assessment
Muscle Thickness
Time frame: One time assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Garcia Bernal, PT principal investigator
Physiotherapy Department, University of Sevilla, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Muscle Tone Abnormalities, run by University of Seville at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold, assessed by Manual Pressure Algometry (time frame: One time assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.