Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy

NCT05521217 | Unknown

• 1 other identifier: E-10840098-772.02-3771
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscle Tone Poor; Spinal Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Children with Spinal Muscular Atrophy

The patients were included if they were between 0 to 4 yeats, with a diagnosis of Spinal Muscular Atrophy.

Diagnostic Test: MyotonPRO

Healthy children

The healthy age-matched control group was included.

Diagnostic Test: MyotonPRO

Interventions

MyotonPRO DIAGNOSTIC_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.

Children with Spinal Muscular Atrophy; Healthy children

Eligibility Criteria

• Age: 1 Month - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Children of families who disagreed to participate in the study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (2)

Seval Kutlutürk Yıkılmaz

Istanbul, Kavacık, 34810, Turkey (Türkiye)

Location

Seval Kutlutürk Yıkılmaz

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Hypotonia; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Officials

• Seval Kutlutürk Yıkılmaz

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: August 30, 2022
• Study Start: August 26, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-08

Locations

TU (2)