Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy

• Conditions: Muscle Tone Poor; Spinal Muscular Atrophy
• Interventions: Diagnostic Test: MyotonPRO

• Registration Number: NCT05521217
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-26
• Study First Submitted: 2022-08-27
• Study First Submitted QC: 2022-08-27
• Study First Posted: 2022-08-30
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy children	MyotonPRO	The healthy age-matched control group was included.
Children with Spinal Muscular Atrophy	MyotonPRO	The patients were included if they were between 0 to 4 yeats, with a diagnosis of Spinal Muscular Atrophy.

Primary Outcome Measures

Name	Time	Method
Biomechanical and Viscoelastic Properties	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.

Trial Locations

Locations (1)

Seval Kutlutürk Yıkılmaz; 🇹🇷 Istanbul, Turkey