Clinical trial NCT06519396: Achilles Tendon and Balance in Prediabetes
Official title: Ultrasonographic Achilles Tendon Measurements and Static and Dynamic Balance in Prediabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreDiabetes
Keywords: Achilles Tendon
Balance
Prediabetes
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: ultrasonographic measurement of achilles tendon
timeFrame: baseline
measure: balance measurement
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Fulya Bakilan
Study officials:
affiliation: Eskişehir Osmangazi University
name: Fulya Bakilan
role: STUDY_DIRECTOR
References: