Diabetes Mellitus Clinical Trial
— DMumecPROOfficial title:
Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
Verified date | July 2023 |
Source | Bitlis Eren University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 10, 2022 |
Est. primary completion date | May 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Okan University Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Tülay Çevik Saldiran | Okan University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Fear of Falling | Fear of falling will be assessed using the Falls Efficacy Scale International questionnaire. In this scale, scores are treated as continuous variables ranging from 16 to 64, where 16 indicates no concern and 64 indicates severe concern about falling. Participants in this study were further classified as having had low concern (score of 16-19), moderate concern (score of 20-27), or high concern (score =28) about falling. | Day 1. | |
Secondary | Lower Limb Function | The Short Physical Performance Battery will be used for Lower limb function assessment. It is an objective measure of lower-extremity function that includes 4-meter gait speed at usual pace, three standing balance tests, and time to complete five chair rises Composite scores range from 0 to 12 with higher scores reflecting better performance. | Day 1. |
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