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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT06515665
• Lead Sponsor: Hacettepe University

Brief 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.

Detailed Description

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. It is also expected to provide evidence to health professionals working in this field.

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Study Start: 2025-09-30
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• individuals were ability to walk 10 meters with a maximum of one support,
• at most one amputated toe, no thumb,
• accessible to electronic devices with internet,
• no vision and hearing problems,
• no problems that may affect cooperation,
• receiving Hyperbaric Oxygen Therapy.

Exclusion Criteria

• having major amputations,
• having an orthopedic or other neurological problem,
• having a congenital disability,
• having proximal lower extremity,
• amputation excluding the finger,
• having bilateral finger amputation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound Healing Evaluation of Individulas With Diabetic Foot	before and after 6 week	Photos will be taken with a phone application called Imit measure.
Performance Evaluation of Individulas With Diabetic Foot	before and after 6 week	one minute walk test
Balance Evaluation of Individuals with Diabetic foot	Before and after 6 week	time up and go test

Secondary Outcome Measures

Name	Time	Method
Comparing the effectiveness of the diabetic recovery orthosis and exercises on performance	before and after 6 week	Comparing week six assessments
Comparing the effectiveness of the diabetic recovery orthosis and exercises on balance	before and after 6 week	Comparing week six assessments
Comparing the effectiveness of the diabetic recovery orthosis and exercises on wound healing	before and after 6 week	Comparing week six assessments

Trial Locations

Locations (1)

University of Health Science; 🇹🇷 Ankara, Kecıoren, Turkey