Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515665
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-13
Brief Title:
Effectiveness of Diabetic Recovery Shoes and Artificial Intelligence Supported Structured Exercise Program
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 testsAwareness 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 testsAwareness 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None