Clinical trial NCT05521217: Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy
Official title: Quantification of the Postural Muscles Mechanical Properties of Individuals With Spinal Muscular Atrophy Using Myotonometer: Intra- and Inter Examiner Reliability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Tone Poor
Spinal Muscular Atrophy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Children of families who disagreed to participate in the study

Primary outcomes:
measure: Biomechanical and Viscoelastic Properties
timeFrame: Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Seval Kutlutürk Yıkılmaz
state: Kavacık
city: Istanbul
country: Turkey
facility: Seval Kutlutürk Yıkılmaz
Study officials:
affiliation: Medipol University
name: Seval Kutlutürk Yıkılmaz
role: PRINCIPAL_INVESTIGATOR
References: