The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters

NCT06846476 | Completed

• 1 other identifier: MedipolU-OPZ-YU-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Postural control and plantar pressure are affected by many parameters in diabetic individuals. It is considered important to examine the relationship between changes in plantar pressure distribution and postural balance, physiological expenditure index and gait parameters in diabetic individuals. Within the scope of this project, based on the above mentioned reasons, we plan to produce a personalised off loading insoles designed for diabetic foot.

Conditions

Diabetic Foot Ulcer (DFU); Orthoses; Postural Balance; Plantar Pressure Distrubution

Keywords

Diabetic Foot; Insole; Postural Balance; Plantar Pressure

Outcome Measures

Primary Outcomes (1)

• Postural Balance

  Postural balance assessment in the study will be performed with 'Becure Balance System (Becure Global GmbH)'. It is planned to perform balance assessment of individuals on the device with eyes open-closed, single foot-double foot. After the participant is positioned on the balance board, balance evaluations will be made in different situations such as eyes open-closed, single foot-double foot. Changes in the centre of gravity on the x and y axes with the eyes open and closed, and changes in postural oscillation will be examined with the results of the distance of movement expressing the changes in the centre of gravity. The postural balance assessment conducted in the study provides all the parameters mentioned above in centimeters. These values represent postural sway.

  the evaluation of balance and postural control will be carried out before and in the 3rd month of insoles use and the effects on individuals will be compared.

Secondary Outcomes (1)

• The Physiological Cost Index (PCI)

  Evaluation will be made before and in the 3rd month of insoles use.

Study Arms (1)

All participants

EXPERIMENTAL

Using diabetic insole and will participate in all assessment methods.

Other: Insole; Other: Demographic Information and Anamnesis Form; Other: Pedobarographic analysis; Other: Postural balance; Other: The Foot Functional Index (FFI); Other: Sensory Evaluation; Other: Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0); Other: 6 Minute Walk Test (6MWT); Other: Pulse Oximeter Heart Rate and Oxygen Saturation

Interventions

Insole OTHER

The production process of the insoles will be produced by Computer Aided Design and Computer Aided Manufacturing (CAD-CAM) method by making plantar pressure analysis and physical evaluation of the individual. The insoles will be designed to reduce the load in areas where the pressure is high with off loading technique. The design of the insoles to be produced individually will be made by the researcher (expert orthotist). The materials to be used in the production of insoles will be determined according to the needs of the participant and materials suitable for diabetic individuals will be preferred. In this context; mostly Ethyl Vinyl Acetate (EVA) and materials with cellular air permeability on the upper surface will be used.

All participants

Demographic Information and Anamnesis Form OTHER

Demographic information and anamnesis form; demographic information of the participant, disease history, physical condition of the foot, skin condition, medications used, allergic status, surgical history, presence of edema, discolouration and temperature increase.

All participants

Pedobarographic analysis OTHER

Pedobarographic analysis and evaluation of postural balance are widely used by clinicians and researchers to examine the foot structure and to determine the loading patterns of the foot. The data are obtained with electronic sensors placed on the platform where the gait takes place. The sensors are directly connected to the platforms and the computer system programmed to perform foot analysis. With the pedobarography device, pressure distribution data in the foot are obtained in both static and dynamic conditions. Foot plantar pressure analysis and postural balance will be performed using the EsCoSCAN® static and dynamic pedobarographic assessment device. During the analysis, the individual will be made to stand without moving while looking straight ahead in the standing position for static analysis. This evaluation will be performed before and 3 months after the use of insoles.

All participants

Postural balance OTHER

Postural balance assessment in the study will be performed with 'Becure Balance System (Becure Global GmbH)'. Individuals will be evaluated for balance on the device with eyes open-closed, single foot-double foot. This evaluation will be performed before and 3 months after the use of insoles.

All participants

The Foot Functional Index (FFI) OTHER

The Foot Functional Index (FFI) consists of pain, disability and activity limitation and contains a total of 23 items. Pain and disability titles consist of 9 questions each. The pain item measures the severity of foot pain in different situations. The 9 items in the inability heading assess the severity of the difficulty in performing functional activities due to the person's foot problems. The activity limitation heading consists of 5 items and measures the activity limitations of the person due to foot problems. AFI is a self-completed scale. Individuals answer the questions with a Visual Analogue Scale (VAS), taking into account their foot condition one week ago. A high score indicates more pain, inability and activity limitation. This evaluation will be performed before and 3 months after the use of insoles.

All participants

Sensory Evaluation OTHER

Diabetic foot ulcer (DFU), which is one of the microvascular complications of diabetes, frequently occurs in association with loss of protective sensation due to peripheral neuropathy, ischaemia due to peripheral arterial insufficiency, poor foot care and infection. Loss of pressure sensation caused by peripheral nerve damage will be evaluated with 'Semmes Weinstein' monoflaments. The 5.07 nylon monoflament used in the test was produced to bend when 10 g force was applied. This pressure is applied to specific points on the plantar and dorsal aspect of the foot. This evaluation will be performed before and 3 months after the use of insoles.

All participants

Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0) OTHER

It is a standardised and widely used questionnaire developed to examine the satisfaction of individuals using orthotics with the device they use. In 2020, a Turkish validity and reliability study was conducted. QUEST 2.0 consists of 12 items. Of these, 8 items question the assistive device and 4 items question service satisfaction. Scale scoring is calculated with a 5-point Likert scale (1=Not satisfied at all, 5=Very satisfied). This evaluation will be performed after the use of insoles.

All participants

6 Minute Walk Test (6MWT) OTHER

Participants will walk for 6 minutes at a speed of their choice in a flat and suitable area of 30 metres. The distance walked in 6 minutes will be recorded in metres.

All participants

Pulse Oximeter Heart Rate and Oxygen Saturation OTHER

Heart rate and oxygen saturation (SpO2) will be recorded by pulse oximetry before and after the 6MWT. The pulse oximeter is a non-invasive device that attaches to a person's fingertip.

All participants

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 40 and 65,
• Wagner Classification stages 0 or 1,
• He has type I or type II diabetes,
• No history of amputation surgery,
• Individuals using shoes suitable for insoles will be included in the study.

You may not qualify if:

• \- Using an assistive device (long-walking device, walker, canadiene, etc.),
• He has a history of amputation,
• He has a Charcot foot deformity,
• The one with the open wound,
• Physical disability that may restrict joint movement,
• Individuals using shoes that are not suitable for insoles will not be included in the study.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34794, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Foot Orthoses; Postural Balance; Oxygen Saturation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Proprioception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Metabolism

Study Officials

• YAGMUR UYSAL

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: There will be only one group in our study. This group will be evaluated before and in the 3rd month of insoles use.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 26, 2025
• Study Start: December 24, 2024
• Primary Completion: May 8, 2025
• Study Completion: August 15, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)