Achilles Tendon and Balance in Prediabetes

Ultrasonographic Achilles Tendon Measurements and Static and Dynamic Balance in Prediabetes

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Device: ultrasonography evaluation; Device: tetrax device evaluation

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Eskisehir, Turkey
    • Fulya Bakilan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional study was conducted with 90 patients who were admitted to a Physical Medicine and Rehabilitation outpatient clinic. The patients were divided into three groups: 1) the control group (patients who were neither prediabetic nor diabetic; 2) the prediabetes group (prediabetic patients); and 3) the Diabetes Mellitus group (patients with Type 2 Diabetes Mellitus).

Description

Inclusion Criteria:

• being between 40 and 65 years old

Exclusion Criteria:

• extremity amputation
• vitamin B12 deficiency
• Type 1 Diabetes Mellitus
• prior exposure to neurotoxic agents
• peripheral neuropathy for reasons such as chronic kidney failure, liver failure, - hypothyroidism, hereditary and inflammatory peripheral neuropathies, neuromuscular diseases, malignancies
• anti-neuropathic drug usage
• radiculopathy
• nerve trauma or surgery
• vasculitis and autoimmune disorders
• peripheral vascular disease
• pregnancy
• vestibular and cerebellar problems
• history of lower extremity surgery
• presence of medication affecting balance
• history of alcoholism
• presence of visual impairment.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Patients in the control group had FPG< 100 mg/dl or 75g oral glucose tolerance test: second hour plasma glucose <140mg/dl and HbA1c values <5.7%.	Device: ultrasonography evaluation; Ultrasonographic 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; Device: tetrax device evaluation; A 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
Prediabetes; The diagnosis of prediabetes was also confirmed through the patients' medical records. Patients with FPG 100-125 mg/dl or 75g oral glucose tolerance test: second hour plasma glucose 140-199 mg/dl and HbA1c values 5.7-6.4% was included in the prediabetes group.	Device: ultrasonography evaluation; Ultrasonographic 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; Device: tetrax device evaluation; A 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
Diabetes; The diagnosis of Type 2 Diabetes was confirmed through the patients' medical records. Patients with FPG≥ 126mg/dl or 75g oral glucose tolerance test: second hour plasma glucose ≥200mg/dl and HbA1c ≥6.5% were included in the diabetes group.	Device: ultrasonography evaluation; Ultrasonographic 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; Device: tetrax device evaluation; A 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasonographic measurement of achilles tendon	measurements of thickness (anterior-posterior), width (medial-lateral), and area of achilles tendon at the level of the medial malleolus were made	baseline
balance measurement	Static balance measurement were made with Tetrax Device	baseline

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Study Director: Fulya Bakilan, Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Prediabetes; Achilles Tendon
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: Achilles

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