Muscle Tone PoorNCT05521217
Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy
An observational study of Muscle Tone Poor and Spinal Muscular Atrophy, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The primary aim of the study was to measure the intra-rater and inter-rater reliability of MyotonPRO in measuring postural muscle tone and mechanical properties in individuals with spinal muscular atrophy (SMA). Read more about this study
- Who is it for?
- Ages 1 month to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Poor, Spinal Muscular Atrophy
- What is being tested?
- MyotonPRO
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 26 Aug 2022to 15 Oct 2022
- 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 1 month to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study was to be conducted with children with a diagnosis of Spinal Muscular Atrophy (SMA) followed in the Pediatric Chest Diseases Outpatient Clinic at Bağcılar Medipol Mega University Hospital and Istanbul Medipol Hospital, and with their families meeting the inclusion criteria of the study.
Who may be able to join
- Between 0-4 years old
- Diagnosed with spinal muscular atrophy (SMA)
- Children who continue their medical treatment at home and are not in intensive care
- Children of families who agreed to participate in the study and approved the informed consent form.
Who cannot join
- Children of families who disagreed to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Seval Kutlutürk Yıkılmaz
Istanbul, Kavacık, 34810
Seval Kutlutürk Yıkılmaz
Istanbul, 34810
About this study
Official title: Quantification of the Postural Muscles Mechanical Properties of Individuals With Spinal Muscular Atrophy Using Myotonometer: Intra- and Inter Examiner Reliability
The primary aim of the study was to measure the intra-rater and inter-rater reliability of MyotonPRO in measuring postural muscle tone and mechanical properties in individuals with spinal muscular atrophy (SMA). The secondary aim is to question the existence of a relationship between the functional levels of individuals with SMA and their muscle tone and biomechanical properties. It is assumed that the outputs to be obtained from this research will form the norm data for moyotonometer evaluation in children with SMA.
Read the detailed description
It seems to be important to examine peripheral changes in the pathogenesis of SMA. Although it shows that the target center in SMA is alpha motor neurons located in the anterior horn of the spinal cord, considering the interaction network of interneurons, cerebellum, neuromuscular junction, gamma-alpha motor neuron pool, descending and ascending pathways, and reflex arc, it has potential to be investigated in individuals with SMA. This suggests that it may have important consequences for peripheral mechanisms. It may be important to examine muscle mechanical properties to reveal any potential correlations between SMA types and disease progression. In addition, moyotonometer results can be a key evaluation method in examining treatment efficacy, diagnosis and disease course. However, in order for these activities to be observed with myotonometer, first of all, the reliability of its use in individuals with SMA should be questioned.
- Conditions
- Muscle Tone Poor, Spinal Muscular Atrophy
- Being tested
- MyotonPRO
- Medical subject headings
- Muscle Hypotonia, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyotonPRODiagnostic test
Evaluation of biomechanics and viscoelastic properties of posture muscle in children with Spinal Muscular Atrophy.
The biomechanical and viscoelastic properties of the posture muscle in children with Spinal Muscular Atrophy. will be measured with the MyotonPRO device.
| Study group | Role | What they receive |
|---|---|---|
| Children with Spinal Muscular Atrophy | The patients were included if they were between 0 to 4 yeats, with a diagnosis of Spinal Muscular Atrophy. Receives: Diagnostic Test: MyotonPRO | |
| Healthy children | The healthy age-matched control group was included. Receives: Diagnostic Test: MyotonPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical and Viscoelastic Properties
The biomechanical and viscoelastic properties of the plantar fascia will be measured with MyotonPRO device. The MyotonPRO (Tallin, Estonia) is a portable hand-held myotonometer. This device is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by different parameters such as tone, elasticity, and stiffness. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start26 Aug 2022
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Tone PoorStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seval Kutlutürk Yıkılmaz, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521217
- Sponsor's protocol ID
- E-10840098-772.02-3771
- Status last verified
- Aug 2022
- First submitted
- 27 Aug 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Postural Muscles Mechanical Properties of Individuals With Spinal Muscular Atrophy Using Myotonometer: Intra- and Inter Examiner Reliability
- ClinicalTrials.gov ID
- NCT05521217
- Acronym / sponsor ID
- E-10840098-772.02-3771
- Conditions
- Muscle Tone Poor, Spinal Muscular Atrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 30 Aug 2022 (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.
The primary aim of the study was to measure the intra-rater and inter-rater reliability of MyotonPRO in measuring postural muscle tone and mechanical properties in individuals with spinal muscular atrophy (SMA). The secondary aim is to question the existence of a relationship between the functional levels of individuals with SMA and their muscle tone and biomechanical properties. It is assumed that the outputs to be obtained from this research will form the norm data for moyotonometer evaluation in children with SMA.
Detailed description
It seems to be important to examine peripheral changes in the pathogenesis of SMA. Although it shows that the target center in SMA is alpha motor neurons located in the anterior horn of the spinal cord, considering the interaction network of interneurons, cerebellum, neuromuscular junction, gamma-alpha motor neuron pool, descending and ascending pathways, and reflex arc, it has potential to be investigated in individuals with SMA. This suggests that it may have important consequences for peripheral mechanisms. It may be important to examine muscle mechanical properties to reveal any potential correlations between SMA types and disease progression. In addition, moyotonometer results can be a key evaluation method in examining treatment efficacy, diagnosis and disease course. However, in order for these activities to be observed with myotonometer, first of all, the reliability of its use in individuals with SMA should be questioned.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Spinal Muscular Atrophy | – | Diagnostic Test: MyotonPROThe patients were included if they were between 0 to 4 yeats, with a diagnosis of Spinal Muscular Atrophy. |
| Healthy children | – | Diagnostic Test: MyotonPROThe healthy age-matched control group was included. |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study was to be conducted with children with a diagnosis of Spinal Muscular Atrophy (SMA) followed in the Pediatric Chest Diseases Outpatient Clinic at Bağcılar Medipol Mega University Hospital and Istanbul Medipol Hospital, and with their families meeting the inclusion criteria of the study.
Key inclusion criteria (4 listed)
- Between 0-4 years old
- Diagnosed with spinal muscular atrophy (SMA)
- Children who continue their medical treatment at home and are not in intensive care
- Children of families who agreed to participate in the study and approved the informed consent form.
Key exclusion criteria (1 listed)
- Children of families who disagreed to participate in the study
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 |
|---|---|---|
| MyotonPROEvaluation of biomechanics and viscoelastic properties of posture muscle in children with Spinal Muscular Atrophy. The biomechanical and viscoelastic properties of the posture muscle in children with Spinal Muscular Atrophy. will be measured with the MyotonPRO device. | Diagnostic test | Children with Spinal Muscular Atrophy, Healthy children |
Primary outcome
Biomechanical and Viscoelastic Properties
Time frame: Day 1.
The biomechanical and viscoelastic properties of the plantar fascia will be measured with MyotonPRO device. The MyotonPRO (Tallin, Estonia) is a portable hand-held myotonometer. This device is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by different parameters such as tone, elasticity, and stiffness. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: Undecided
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.
Seval Kutlutürk Yıkılmaz principal investigator
Medipol University
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 Muscle Tone Poor and Spinal Muscular Atrophy, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Biomechanical and Viscoelastic Properties (time frame: Day 1.). 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 25 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.