Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties

NCT05452551 | Completed

• 1 other identifier: BEU-IK-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus; Plantar Fascia

Keywords

Diabetes

Outcome Measures

Primary Outcomes (3)

• Muscle Tone (Hz)

  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.

  Day 1

• Stiffness (N/m)

  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.

  Day 1

• Logarithmic decrement

  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.

  Day 1

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults between 18-35 years old diagnosed with Type 2 Diabetes

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• İlke KARA, PT: lead
• Bitlis Eren University: collaborator
• Medipol University: collaborator

Study Sites (1)

Bitlis Eren University

Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tülay Çevik Saldıran, PhD

  Bitlis Eren University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: July 6, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)