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Clinical Trials/NCT04444375
NCT04444375
Completed
Not Applicable

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

Suleyman Demirel University1 site in 1 country54 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Suleyman Demirel University
Enrollment
54
Locations
1
Primary Endpoint
the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
May 30, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mehmet Duray

Principal Investigator

Suleyman Demirel University

Eligibility Criteria

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

Outcomes

Primary Outcomes

the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)

Time Frame: 6 months

balance

Foot Function Index

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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