Clinical Trials Directory

Trials / Completed

CompletedNCT06519396

Achilles Tendon and Balance in Prediabetes

Ultrasonographic Achilles Tendon Measurements and Static and Dynamic Balance in Prediabetes

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
Eskisehir Osmangazi University · Academic / Other
Sex
All
Age
40 Years – 65 Years
Healthy volunteers
Accepted

Summary

The aim was to evaluate the Achilles tendon size and static and dynamic balance, as well as the role of Achilles tendon on balance in prediabetes. A total of 96 patients were divided into three groups: 1)the control group, consisting of patients without diabetes; 2)the prediabetes group; 3)the diabetes mellitus group. Ultrasonographic measurements of Achilles tendon sizes were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance was assessed.The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.

Detailed description

Background/Aims: There is a lack of studies that examine balance problems and Achilles tendon thickness in prediabetes, despite their common occurrence in diabetes. The aim was to evaluate the Achilles tendon size and static and dynamic balance, as well as the role of Achilles tendon on balance in prediabetic patients. Methods: A total of 96 patients were divided into three groups: 1)the control group, consisting of patients without diabetes; 2)the prediabetes group; 3)the diabetes mellitus group. Ultrasonographic measurements of Achilles tendon sizes (thickness, width and area) were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance (the Fall Index, Stability Indexes) was assessed using a Tetrax device. The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.

Conditions

Interventions

TypeNameDescription
DEVICEultrasonography evaluationUltrasonographic measurements of the Achilles tendon were taken using Samsung Sonoace X7 ultrasound system equipped with an 8-13MHz linear transducer. After assuming a prone position on the examination table, the patients placed their feet against the wall and flexed their ankles to ensure optimal contact between the probe and the tendon. Measurements were taken separately on the right and left sides for each patient. Initially, the probe was positioned perpendicular to the long axis of the tendon for an axial plane assessment, followed by measurements of thickness (anterior-posterior), width (medial-lateral), and area at the level of the medial malleolus. The thickness and width measurements utilized the tendon's major axes, while the area measurements were automatically calculated by the device through continuous tracing of the tendon circumference in the same section
DEVICEtetrax device evaluationA Tetrax device was used to assess static balance. The patient was positioned on the platform and subjected to tests in eight different positions. For each position, a test measurement was made for a duration of 32 seconds, for a total of approximately 5 minutes. The normal eyes-open position was taken as the reference. The effects of vision on balance were observed in the eyes-closed position. Balance is dependent on the back of the heels and the lower vertebrae in this position. Conversely, in the eyes-closed position with the head tilted 30 degrees forward, there is a load on the upper vertebrae and neck. Following the measurements, the Tetrax software program was used to calculate the Fall Index and Stability Index

Timeline

Start date
2023-02-01
Primary completion
2023-11-20
Completion
2023-11-30
First posted
2024-07-25
Last updated
2024-07-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06519396. Inclusion in this directory is not an endorsement.