Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties

NCT ID: NCT05452551

Last Updated: 2023-04-07

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-06

Study Completion Date

2022-06-01

Brief Summary

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The study aims to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

Detailed Description

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Therefore, changes occur in standing weight-bearing points, loading zones, and gait biomechanics. The thickened plantar fascia increases the risk of developing diabetic foot with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in individuals with diabetes than in healthy individuals. The myotonometer studies showed that chronic diabetes history increases dynamic stiffness, which is one of the mechanical properties of the plantar fascia, and that as the severity of the disease increases, fascial stiffness also increases. The aim of the study is to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

Conditions

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Diabetes Diabetes Mellitus Plantar Fascia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Myotonometric measurement

MyotonPRO is a non-invasive myotonometer used to evaluate the viscoelastic properties of soft tissues. Data collection will be carried out by three researchers experienced in the use of myotonometer. Before the evaluations, participant and repeated measurement information for both researchers will be recorded on the device. All assessments will be made bilaterally. The first researcher will perform two measurements 30 minutes apart from the measurement point standardized with MyotonPRO to evaluate the plantar mechanical properties. Then, the second researcher will take two measurements with MyotonPRO from the same point with 30 minutes intervals. One day later, the first researcher will measure again from the same reference point once.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Body mass index \< 30 kilogram/meter square
* Willing to participate in the study
* Diagnosed with Type 2 Diabetes
* HbA1c level ≥ 6.5% mmol/mol
* Fasting plasma glucose ≥126 mg/dl
* Random plasma glucose ≥ 200 mg/d

Exclusion Criteria

* History of lower extremity injuries
* Ulceration localized on plantar fascia
* Age ≥ 65 years
* Any use of medication that will affect muscle tone
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role collaborator

Medipol University

OTHER

Sponsor Role collaborator

İlke KARA, PT

OTHER

Sponsor Role lead

Responsible Party

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İlke KARA, PT

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tülay Çevik Saldıran, PhD

Role: STUDY_DIRECTOR

Bitlis Eren University

Locations

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Bitlis Eren University

Bitlis, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BEU-IK-02

Identifier Type: -

Identifier Source: org_study_id

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