Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus

Completed

• Conditions: Diabetes Mellitus
• Interventions: Diagnostic Test: balance test

• Registration Number: NCT04444375
• Lead Sponsor: Suleyman Demirel University

Brief Summary

Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common risk factors for plantar pain and related disability. The aim of our study was to evaluate the relationship between plantar pain, balance and foot function in diabetic DM patients has with different BMI.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Study First Submitted: 2020-05-29
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-23
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• having plantar pain
• and no change in BMI by more than 10% for at least 3 months
• being volunteer to participate to the study

Exclusion Criteria

• having musculoskeletal surgery for foot
• having neurological, orthopedic, and cardiovascular diseases
• vision and hearing problems that may cause balance disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese, non-obese	balance test	obese and non-obese diabetic patients

Primary Outcome Measures

Name	Time	Method
the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)	6 months	balance
Foot Function Index	6 months	Foot Function Index of 23 items, and evaluates the pain, disability and activity limitation. The each of the pain and insufficiency subscales consist of 9 items and the activity limitation subscale includes 5 items. Patients score their foot pain level with Visual Analogue Scale (VAS) in various situations during the last 1 week. To calculate the scores of the index, the score of each item are summed, then divided by possible the maximum score can be obtained from the FFI. Higher scores indicate greater pain, disability and activity limitation level.
Manchester Foot Pain and Disability Index	6 months	Manchester Foot Pain and Disability Index consists of 4 subsections including 9 questions for inadequacy, 5 questions for pain, 3 questions for concern and 2 questions for difficulty. Each item is scored between 0-2. The total score is calculated by summing the scores from all items. Higher scores indicate worse health situation.

Trial Locations

Locations (1)

Mehmet Duray; 🇹🇷 Isparta, Turkey