Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
DMumecPRO
1 other identifier
observational
50
1 country
1
Brief Summary
In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2022
CompletedJuly 27, 2023
July 1, 2023
8 months
September 20, 2021
July 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biomechanical and Viscoelastic Properties
The biomechanical and viscoelastic properties of the plantar fascia will be measured with MyotonPRO device. The MyotonPRO (Tallin, Estonia) is a portable hand-held myotonometer. This device is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by different parameters such as tone, elasticity, and stiffness. 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.
Day 1.
Secondary Outcomes (2)
Fear of Falling
Day 1.
Lower Limb Function
Day 1.
Study Arms (2)
Diabetic Group
The patients were included if they were of 18 years or older, with a diagnosis of diabetes mellitus for more than three years.
NonDiabetic Group
The healthy age-matched control group was included.
Interventions
The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.
Eligibility Criteria
Patients with a diagnosis of diabetes mellitus for more than three years or individuals without a history of diabetes mellitus affirmed by a normal range of fasting blood sugar and hemoglobin A1C levels.
You may qualify if:
- Diagnosed with diabetes mellitus for more than three years
- Individuals without a history of diabetes mellitus affirmed by a normal range of fasting blood sugar and hemoglobin A1C levels.
- Age≥18 years
You may not qualify if:
- History of central nervous system conditions
- No visual and vestibular impairments
- Amputation of the lower limb
- History of fracture
- Surgery of lumbar and lower limb
- Having pain resulting in movement difficulty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tülay Çevik Saldıranlead
- Okan Universitycollaborator
Study Sites (1)
Okan University Hospital
Istanbul, 34959, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
September 20, 2021
First Posted
September 29, 2021
Study Start
September 20, 2021
Primary Completion
May 30, 2022
Study Completion
July 10, 2022
Last Updated
July 27, 2023
Record last verified: 2023-07