University of Health Science
Ankara, Kecıoren, 06018, Turkey (Türkiye)
NCT Number: NCT06515665
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.
Trial opening soon.
Get Notified40 year–65 year
All sexes
Interventional
Not applicable
Ankara, Kecıoren, 06018, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
They will be asked to behaviorally wear this shoe and perform the exercises daily for 6 weeks.
Other names: exercises
Time frame: Before and after 6 week
time up and go test
Time frame: before and after 6 week
one minute walk test
Time frame: before and after 6 week
Photos will be taken with a phone application called Imit measure.
Time frame: before and after 6 week
Comparing week six assessments
Time frame: before and after 6 week
Comparing week six assessments
Time frame: before and after 6 week
Comparing week six assessments
Contact information is provided by the study sponsor or research team.
Hacettepe University
Other
Investigation of the Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program in Individuals with Diabetic Foot Receiving Hyperbaric Oxygen Therapy
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