Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program
NCT Number: NCT06515665
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer
Interventions: BEHAVIORAL: therapeutic foot orthosis
Sponsor: Hacettepe University
Collaborators: Gulhane Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-30
Completion Date: 2024-12-30
Locations: University of Health Science, Ankara, Kecıoren, 06018, Turkey

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.

Primary Outcome Measures: Balance Evaluation of Individuals with Diabetic foot, time up and go test, Before and after 6 week|Performance Evaluation of Individulas With Diabetic Foot, one minute walk test, before and after 6 week|Wound Healing Evaluation of Individulas With Diabetic Foot, Photos will be taken with a phone application called Imit measure., before and after 6 week
Secondary Outcome Measures: Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance, Comparing week six assessments, before and after 6 week|Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance, Comparing week six assessments, before and after 6 week|Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing, Comparing week six assessments, before and after 6 week