Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties

Sponsor
İlke KARA, PT (Other)
Overall Status
Recruiting
CT.gov ID
NCT05452551
Collaborator
Bitlis Eren University (Other), Medipol University (Other)
30
1
22.8
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties in Individuals With Diabetes
Actual Study Start Date :
Jul 6, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Muscle Tone (Hz) [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bitlis Eren University Bitlis Turkey 13000

Sponsors and Collaborators

  • İlke KARA, PT
  • Bitlis Eren University
  • Medipol University

Investigators

  • Study Director: Tülay Çevik Saldıran, PhD, Bitlis Eren University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
İlke KARA, PT, Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05452551
Other Study ID Numbers:
  • BEU-IK-02
First Posted:
Jul 11, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by İlke KARA, PT, Investigator, Dokuz Eylul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022