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NOT YET RECRUITING
NCT06515665
NA

Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program

Sponsor: Hacettepe University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the effectiveness of the diabetic recovery sandal and artificial intelligence supported structured exercise program in individuals diagnosed with diabetic foot receiving hyperbaric oxygen therapy. The study will include 66 individuals between the ages of 40-65 who have received a diagnosis of diabetic foot from a specialist doctor, have a forefoot wound and receive hyperbaric oxygen therapy. The included individuals will be randomly divided into 3 groups. All participants will be provided with appropriate wound care and dressing and will be randomly divided into 3 groups. Artificial intelligence assisted exercise (exercise group) will be applied to the 1st group. Group 2 will receive artificial intelligence-assisted exercises and healing sandals. For 6 weeks, diabetic foot exercises and diabetic recovery sandal use will be provided (Exercise + sandal group). 3 groups will not receive any contribution (Control group). Balance, performance, wound healing and muscle strength evaluations will be performed before and after the application. Balance assessments will be evaluated by timed get up and walk test, performance by 1 min walk test, wound healing by Imitto measure phone application and muscle strength assessments by manual muscle tests.Awareness of the use of recovery sandals, hyperbaric oxygen therapy and foot exercises will be increased. Attention will be drawn to the creation of new education programs for people with low education or perception, and necessary measures will be taken in cases where risk is identified. In addition, early detection of recurrent ulcers or amputations in individuals who may increase the level of amputation will increase the risk of hospitalization and at the same time increase the cost of care that needs to be spent during hospitalization.

Official title: Investigation of the Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program in Individuals with Diabetic Foot Receiving Hyperbaric Oxygen Therapy

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-09-30

Completion Date

2026-12-30

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

BEHAVIORAL

therapeutic foot orthosis

They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.

Locations (1)

University of Health Science

Ankara, Kecıoren, Turkey (Türkiye)