Clinical trial NCT05974020: Investigation of the Effect of Foot Intrinsic Muscle Training in Individuals With Diabetic Foot Syndrome
Official title: Investigation of the Effect of Foot Intrinsic Muscle Training on Foot Posture and Plantar Pressure Distribution in Individuals With Diabetic Foot Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Keywords: diabetic foot
exercise
plantar pressure
intrinsic mucle training
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this experimental randomized controlled study is to evaluate the effectiveness of the exercise program to be applied to prevent foot wounds, which is one of the leading foot problems that develop as a result of diabetes, based on foot posture and plantar pressure distribution.

Participants who meet the inclusion criteria and are between the ages of 18-65 will be randomly assigned to one of the two experimental groups or the control group.Participants will be assessed through surveys to evaluate their physical activity level, foot health and functionality, and sensory status of the feet. Measurements related to foot position and posture will be taken. The use of a pedobarography device will allow for the examination of plantar pressure distribution. Following these assessments, participants will receive general foot care instructions and information on appropriate footwear, along with the designated exercise program.

During routine check-ups and treatment procedures related to diabetes, blood glucose levels and HbA1c values taken from participants will be analyzed by the physician before and after the program to make comparisons. The study is planned to last for 12 weeks, and evaluations will be conducted before and after the program.

Detailed description: According to the literature, evaluations for preventing and treating diabetic foot ulcers commonly include plantar pressure measurements, and it is emphasized that methods involving plantar pressure technologies should be added to traditional evaluations to be more successful in preventing diabetic foot ulcers, even in high-risk individuals.

Based on the findings from previous research, it is believed that the reduced foot intrinsic muscle strength, which has not been extensively examined in its relationship with other factors, needs to be systematically investigated for its effects on foot related measurements and plantar pressure. Furthermore, there seems to be insufficient information regarding exercise interventions focusing on foot intrinsic muscle training for preventing ulcer development in diabetic foot. Therefore, the aim of the study is to examine the effects of foot intrinsic muscle training on foot posture and plantar pressure distribution in individuals with diabetic foot syndrome. By elucidating these factors, it is hoped that the exercise protocol focusing on foot intrinsic muscle training, implemented to prevent ulcer formation, will contribute to the literature and reduce the burdens associated with the disease.

Hypotheses of the study:

H0: Foot intrinsic muscle training has no effect on plantar pressure in individuals with diabetic foot syndrome.

H1: Foot intrinsic muscle training has an effect on plantar pressure in individuals with diabetic foot syndrome.

H2: Foot intrinsic muscle training has no effect on foot posture in individuals with diabetic foot syndrome.

H3: Foot intrinsic muscle training has an effect on foot posture in individuals with diabetic foot syndrome.

In this study, individuals with diabetic foot syndrome between the ages of 18-65 will be included. The study is designed as a randomized controlled trial, and the participants will be divided into three groups: one control group (Group 1) and two experimental groups (Group 2 and Group 3). The sample size was determined using the G-power program. According to the results obtained, it was calculated that a total of 30 individuals should be included in the study, with 10 participants in each group, considering a statistical power level of 82% and a significance level of 5%.

As part of the research, investigators will gain insights into participants' foot health through questionnaire questions, complete observational analyses of foot and foot-related measurements, evaluate participants' plantar pressure distribution using pedobarographic analysis, and implement exercise protocols focusing on foot intrinsic muscle training.

The study was designed with evaluation and treatment protocols. Demographic information and physical activity levels of the participants to be included in the study will be recorded. The measurements related to the foot will include evaluation of foot posture, goniometric measurements, assessment of tactile sensation, plantar pressure distribution analysis, and questionnaire evaluations. In addition to all these assessments, participants' blood values will be examined by the doctor before and after treatment.

The treatment protocols consist of general foot care instructions and information about appropriate footwear selection, along with exercise protocols. Group 1 - Control Group participants will receive only general foot care instructions and education on appropriate footwear selection. Group 2 participants will receive general foot care instructions and education on appropriate footwear selection, along with an exercise protocol focusing on foot intrinsic muscle training. Group 3 participants will receive general foot care instructions and education on appropriate footwear selection, foot intrinsic muscle training, and in addition, an aerobic exercise protocol. The treatment protocols will be implemented for 12 weeks, and pre- and post-treatment evaluations will be repeated to compare the results.

Eligibility criteria: Inclusion Criteria:

* Agree to participate in the study voluntarily
* Be between the ages of 18-65
* Being diagnosed with type 1 or type 2 diabetes

Exclusion Criteria:

* Refusing to participate in the study or wanting to leave the study
* Presence of severe deformity and/or orthopedic problem in the foot
* Presence of foot ulcer
* History of lower extremity surgery
* History of lower extremity amputation
* Having serious comorbidities (renal failure, severe retinopathy, cardiac problems, neurological problems)

Primary outcomes:
measure: Plantar Pressure Distribution
timeFrame: 3 months
Secondary outcomes:
measure: Foot Posture
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri University
state: Üsküdar
Study officials:
affiliation: Saglik Bilimleri University
name: Dilara Akar
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273.
citation: Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, LeMaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK. Comprehensive foot examination and risk assessment. A report of the Task Force of the Foot Care Interest Group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Phys Ther. 2008 Nov;88(11):1436-43. doi: 10.1093/ptj/88.11.1436. No abstract available.