Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy

Spinal Muscular Atrophy Clinical Trial

Official title:

Quantification of the Postural Muscles Mechanical Properties of Individuals With Spinal Muscular Atrophy Using Myotonometer: Intra- and Inter Examiner Reliability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05521217
• Other study ID #: E-10840098-772.02-3771
• Status: Enrolling by invitation
• Start date: August 26, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: August 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Muscle Hypotonia
• Muscle Tone Poor
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Spinal Muscular Atrophy

Intervention

Diagnostic Test:
• MyotonPRO
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.

Locations

Country	Name	City	State
Turkey	Seval Kutlutürk Yikilmaz	Istanbul	Kavacik
Turkey	Seval Kutlutürk Yikilmaz	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1.