Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetes; Plantar Fascia
• Intervention / Treatment: Other: Myotonometric measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Bitlis, Turkey, 13000
    • Bitlis Eren University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: İlke KARA, PT
• Collaborators: Medipol University; Bitlis Eren University
• Investigators: Study Director: Tülay Çevik Saldıran, PhD, Bitlis Eren University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: BEU-IK-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No