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

Medipol University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06846476

MedipolU-OPZ-YU-01

Details and patient eligibility

About

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.

Full description

Excessive localized loading on the plantar surface leads to repeated microtrauma and the development of diabetic foot ulcers. The plantar region, subjected to constant weight-bearing pressure, develops chronic wounds due to dangerous vascularity. Excessive plantar pressure is considered the primary risk factor for plantar ulcers in diabetic individuals; custom insoles are considered the gold standard in treatment for off-loading plantar pressure.

The off-loading technique, which reduces plantar pressure, is an effective ulcer prevention strategy for neuropathic feet with impaired sensation and increased plantar load and tissue stress.

A review of the literature shows that previous studies have clearly demonstrated that off-loading insoles are effective in reducing abnormal plantar pressure in a specific area and that they also have some effect on the pressure distribution in surrounding areas. However, the potential impact of this positive effect on postural balance, postural control, and individuals' physiological expenditure and energy consumption has not been sufficiently studied.

Therefore, it is considered important to investigate the relationship between changes in plantar pressure distribution, postural balance, physiological expenditure index, and walking parameters in diabetic individuals.

Enrollment: 25 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• - 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

All participants

Experimental group

Description:

Using diabetic insole and will participate in all assessment methods.

Treatment:

Other: Pulse Oximeter Heart Rate and Oxygen Saturation

Other: Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0)

Other: Pedobarographic analysis

Other: 6 Minute Walk Test (6MWT)

Other: The Foot Functional Index (FFI)

Other: Sensory Evaluation

Other: Demographic Information and Anamnesis Form

Other: Postural balance

Other: Insole