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

Sponsor
Hacettepe University
Study ID
NCT06515665
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • therapeutic foot orthosis — BEHAVIORAL
    They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.

Study Details

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.

Key Dates

First listed
Jul 23, 2024
Start date
Sep 30, 2025
Status verified
Mar 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: therapeutic foot orthosis
    foot orthosis will be applied to this group of participants. For 6 weeks they will be asked to use these foot orthoses. Before and after evaluations will be repeated.
  • Active Comparator: exercises
    this group of participants will be exercised with foot orthoses accompanied by artificial intelligence. For 6 weeks, they will be asked to use these foot orthoses and do their exercises. Before and after evaluations will be repeated.
  • Active Comparator: control
    this group of participants will be assessed at the beginning and end of the 6 weeks without any intervention.

Primary Outcome Measure

Balance Evaluation of Individuals with Diabetic foot [ Time Frame: Before and after 6 week ]

Central Contacts

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