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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05521217
Other study ID # E-10840098-772.02-3771
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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