Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy

NCT ID: NCT05521217

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-26

Study Completion Date

2022-10-15

Brief Summary

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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

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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.

Conditions

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Muscle Tone Poor Spinal Muscular Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children with Spinal Muscular Atrophy

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

MyotonPRO

Intervention Type 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.

Healthy children

The healthy age-matched control group was included.

MyotonPRO

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seval Kutlutürk Yıkılmaz

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Seval Kutlutürk Yıkılmaz

Istanbul, Kavacık, Turkey (Türkiye)

Site Status

Seval Kutlutürk Yıkılmaz

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-10840098-772.02-3771

Identifier Type: -

Identifier Source: org_study_id

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