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

NCT04444375 | Completed

• 1 other identifier: 60116787-020/71494
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; plantar pain; body mass index; obesity; balance; foot pain; disability

Outcome Measures

Primary Outcomes (3)

• the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)

  balance

  6 months

• Foot Function Index

  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.

  6 months

• Manchester Foot Pain and Disability Index

  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.

  6 months

Study Arms (1)

obese, non-obese

obese and non-obese diabetic patients

Diagnostic Test: balance test

Interventions

balance test DIAGNOSTIC_TEST

balance test

obese, non-obese

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Diabetes Mellitus

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Mehmet Duray

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

Recruitment Detection, Audiologic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mehmet Duray

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 23, 2020
• Study Start: December 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)