Clinical trial NCT05431660: Diabetic Foot School and Biomechanics
Official title: Effects of Diabetic Foot School on Sensory, Balance and Lower Extremity Biomechanics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plantar pressure senses
timeFrame: immediately after the intervention.
Secondary outcomes:
measure: Vibration sense
timeFrame: immediately after the intervention
Other outcomes:
measure: Patient's Pain
timeFrame: immediately after the intervention
measure: Patient's Pain
timeFrame: immediately after the intervention
measure: lower extremity position sense (proprioception sense);
timeFrame: immediately after the intervention
measure: Lower extremity muscle strengths
timeFrame: immediately after the intervention
measure: Lower extremity strengths
timeFrame: immediately after the intervention
measure: balance
timeFrame: immediately after the intervention
measure: balance
timeFrame: immediately after the intervention
measure: The time-distance characteristics of the gait
timeFrame: immediately after the intervention
measure: Plantar pressures during walking
timeFrame: immediately after the intervention
measure: Individuals' information about diabetic foot
timeFrame: immediately after the intervention.
measure: Individuals' information about diabetic foot
timeFrame: immediately after the intervention.
measure: Individuals' information about diabetic foot
timeFrame: immediately after the intervention.
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Bahar KÜLÜNKOĞLU, assc. prof.
role: STUDY_DIRECTOR
References: