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NCT Number: NCT05452551

Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Plantar Fascia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bitlis Eren University

Bitlis, 13000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myotonometric measurement

Other

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.

Primary outcomes

  1. Muscle Tone (Hz)

    Time frame: Day 1

    The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. 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. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant. The oscillation frequency (Hz) represents the resting muscle tone.

  2. Stiffness (N/m)

    Time frame: Day 1

    The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. 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. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.

  3. Logarithmic decrement

    Time frame: Day 1

    The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. 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. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.

Sponsors and collaborators

Lead sponsor

İlke KARA, PT

Other

Collaborators

  • Bitlis Eren University
  • Medipol University

Registry information

Official study title

Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties in Individuals With Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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