Diabetic Foot School and Biomechanics

Study Overview
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Brief Summary
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The primary aim of the study is to establish a diabetic foot school. The secondary aim is to compare the effects of the training given to diabetic foot patients within the scope of the diabetic foot school, on sensory, balance, lower extremity biomechanics and the effectiveness of these individuals on the knowledge level of diabetic foot. With the evaluations to be made, the effectiveness of the diabetic foot school program will be proven and it will contribute to the literature with objective and evidence-based results. For these reasons, the hypotheses on which the research is based were formed as follows; H11 hypothesis: The diabetic foot school program applied in diabetic foot patients has an effect on foot biomechanical measurements and gait parameters. Hypothesis H12: In diabetic foot patients, the diabetic foot school program has an effect on the sensation of individuals. H13 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the balance of individuals. H14 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the diabetic foot and self-care behaviors of individuals.

Detailed Description
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The study will be carried out in a special gait analysis center. To work; Volunteers, aged 40-70 years, diagnosed with diabetic foot and having type 2 diabetes mellitus with neuropathic symptoms will be included. Participants will be randomly divided into two groups before starting. Trainings will be given to the 1st group within the scope of diabetic foot school, and an exercise program aiming to increase the mobility and strength of the foot will be implemented through video calls twice a week, face-to-face once a week for 8 weeks. The 2nd group will be given a booklet covering this training and they will be followed up with video calls 1 day a week for 8 weeks. In diabetic foot school education, foot anatomy and functions, biomechanics, diabetic foot causes, epidemiology, causes of pain will be explained and treatment methods, ergonomic information, exercises to be done, sensory education, appropriate positions in daily life activities, risky situations, points to be considered and foot care. information will be given. Before the research, individuals will be informed about the purpose and content of the study. Ulcer advanced to Wagner grade 3,4 or 5, standardized mini mental state assessment scale score below 18 points, body mass index over 30, gestational diabetes, malignant tumor, neurological and exacerbated systemic disease, charcot neuroarthropathy, length difference in the lower extremity, fracture, surgical operation and Individuals who have received training on diabetic foot before and who have received other treatments that may affect wound healing will be excluded from the study. All evaluations of both groups will be made by the same physiotherapist before and 8 weeks after the study. At the end of the study, individuals in the 2nd group will be included in the diabetic foot school training upon their wishes. Within the scope of the study, information such as demographic information, smoking status, medical history, ulcer history, previous ulcer locations, if any, medications they use, walking aids/orthotics/diabetic shoes, existing foot deformities will be recorded and Plantar pressure senses; With Semmes-Weinstein monofilaments, Vibration sense; With 128 Hz tuning fork, Pain; with neuropathic pain questionnaire (DN4) and visual analog scale (VAS), lower extremity position sense (proprioception sense); Acumar dual digital inclinometer, Lower extremity muscle strengths (hip flexor, extensor, knee flexor, extensor and ankle plantar flexor and dorsi flexors) with HandHeld Dynamometer muscle dynamometer, Lower extremity strengths with 'Stair Climbing Test (MICT)', their balance; With the 'Get Up and Walk Test' and the 'Functional Reach Test', The time-distance characteristics of the gait will be evaluated by means of a motion-detecting wireless sensor, BTS-G (G Sensor, BTS Bioengineering S.p.A., Italy). Plantar pressures during walking will be evaluated with Rsscan (v9 clinical 2mt plate advanced system) pedobarography. Individuals' knowledge about diabetic foot will be evaluated face to face with diabetic foot knowledge scale, foot self-care behaviors, diabetic foot self-care questionnaire and foot care behavior scale.

Official Title
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Effects of Diabetic Foot School on Sensory, Balance and Lower Extremity Biomechanics

Conditions
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Diabetic Foot

Intervention / Treatment
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* Other: education and exercise protocol about diabetic foot
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with diabetic foot between the ages of 40-70, Type 2 diabetes patients with neuropathic symptoms standard wound care protocol is applied (cleaning the wound with saline, covering it with gauze), sedentary who has not exercised regularly for six months, Able to walk at least 10 meters unaided, Volunteers Exclusion Criteria: Ulcer that has progressed to Wagner grade 3,4 or 5, standardized mini mental state assessment scale score below 18 points, body mass index over 30, gestational diabetes mellitus, malignant tumor, neurological and exacerbated systemic disease, Charcot neuroarthropathy, length difference in lower extremity, fracture, surgical operation and Individuals with previous training in diabetic foot and other treatments that may affect wound healing

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tele-rehabilitation group<br>1st group within the scope of diabetic foot school, and an exercise program aiming to increase the mobility and strength of the foot will be implemented through video calls twice a week, face-to-face once a week for 8 weeks. | Other: education and exercise protocol about diabetic foot<br>* In diabetic foot school education, foot anatomy and functions, biomechanics, diabetic foot causes, epidemiology, causes of pain will be explained and treatment methods, ergonomic information, exercises to be done, sensory education, appropriate positions in daily life activities, risky situations, points to be considered and foot care. information will be given.<br>|
| Active Comparator: face to face training group<br>The 2nd group will be given a booklet covering this training and they will be followed up with video calls 1 day a week for 8 weeks. | Other: control group<br>* diabetic foot school information booklet and weekly video conference meeting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plantar pressure senses | With Semmes-Weinstein monofilaments, In order to understand the test, individuals will be placed on the patient bed with their feet bare in the supine position, and several different points on the soles of the feet will be touched with a thick filament, first with the eyes open and then with the eyes closed, and the individual will be asked to answer yes when they feel the filament touch. . With each filament, each test point on the sole of the foot will be held for 2 seconds by applying pressure 3 times at right angles until the filament bends, and when the individual knows 1 of these 3 touches correctly, the relevant filament thickness will be recorded as the light touch-pressure threshold value for that test point of the individual. | immediately after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vibration sense | It will be evaluated over the first metatarsal head and medial malleolus with a 128 Hz tuning fork. The test will be explained by positioning the individuals as in other tests, and the actual evaluations will begin after the individual expresses that he/she understands the test. The physiotherapist will sit on a chair at the foot of the patient and touch the fork to the test point in an upright position, immediately after hitting the tip of the tuning fork to the foot. In the meantime, the individual was asked to say done as soon as he did not feel the vibration by running the digital stopwatch. The stopwatch will be stopped when the individual says done. Evaluation will be applied 3 times for each test point and the average of the time obtained from the three applications will be recorded as the individual's vibration sense score. | immediately after the intervention |