Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I

Abstract

Background: This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN. Methods/design: Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be footankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance.

Effectiveness of Rebounder and Foot-ankle Exercises on Biomechanics and Quality of Life in Peripheral Neuropathy Patients

“…limbs leads to maintaining more accurate control of the posture, better nerve feedback, and enhancement of balance and walking patterns. Therefore, strengthening muscles, achieving neuromuscular coordination through exercise, and properly summoning motor units after exercises all contribute to improving balance and lowering the risk of falling [22,23]. Since all patients in the experimental groups were able to finish the intervention without injury or complaints, home exercises with a training manual can be utilized as an alternative treatment and part of self-care habits, because they may improve patient adherence to treatment and even reduce the waiting time in outpatient programs, alleviate the symptoms and severity of DPN, increase the functional status of the foot, attain functional balance and make useful biomechanical changes and prevent further complications in rehabilitation programs.…”

“…As the second part refers to general health, only the first part's scores will be used in this study. Each part is scored from 0-100, with 100 being the ideal situation and 0 representing the most terrible [22,23].…”

Could an Internet-Based Foot–Ankle Therapeutic Exercise Program Modify Clinical Outcomes and Gait Biomechanics in People with Diabetic Neuropathy? A Clinical Proof-of-Concept Study

“…The main trial was approved by the ethics committee of the School of Medicine of the University of Sao Paulo (CAAE: 90331718.4.0000.0065) and was prospectively registered at ClinicalTrials.gov on 8 July 2019 (NCT04011267). The full protocol is detailed elsewhere [31]. This clinical proof-of-concept study and the main trial were designed as a parallel-group, two-arm, superiority trial with a 1:1 allocation ratio.…”

The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease

“…Other web-based and remotely delivered methods of physical therapy and rehabilitation may provide further ways to improve gait in people with DPN [81]. A clinical trial is currently in progress to test whether a remotely delivered physical therapy program can improve DPN symptoms and severity as well as gait and function [14].…”