Foot muscle measures of strength and cross-sectional area by ultrasound in the diabetic population.

Brief Name Ultrasound (US) examination of the Intrinsic Foot Muscles (IFM) Biofeedback device assessment of the IFM using ‘Archercise’ Why Diabetic Peripheral Neuropathy (DPN) is a prevalent and debilitating condition. One way of detecting and managing DPN is through the assessment of the Intrinsic Foot Muscles (IFM). Ultrasound (US) has been used to detect IFM muscular atrophy in DPN patients. US is an inexpensive, efficient, and safer imaging modality compared to other such as Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). US can also be used as a biofeedback tool for assessing and improving muscular activation when using real-time functions. In addition, exercise has been found to be beneficial in delaying the usual course of DPN, skin damage and ulceration. However, diabetic patients have lower physical activity rates due to limitations such as difficult access to therapy, poor compliance, and limited support to maintain exercise therapy. Therefore, this study aims to assess whether a newly developed biofeedback device, ‘Archercise’ – a foot muscle exercise and strengthening tool, can correlate IFM Cross-Sectional Area (CSA) measured by US with foot arch control and performance. From this, IFM muscular and functional changes can potentially be detected earlier. In addition IFM strength and control can be monitored and improved What Materials Consent form and Participant Information Statement All participants will receive an ethics approved consent form so that the potential participants have an adequate understanding of the proposed research and the implications of participations. A participant information statement will be provided that outlines in clear and simple terms the purpose of the research and how participants will be involved. Both these forms will be printed and handed to the participants or send electronically via email if the participant requests. Pre-study questionnaire Participants with answer and pre-study questionnaire via a REDCAP survey. The questions involved are: - Age - Sex - Weight - Body Mass Index (BMI) - Duration of Diabetes - Presence of Neuropathic Symptoms using Michigan Neuropathy Screening Instrument Foot Morphology Measures A digital height gauge with a carbide scribe will be used to measure dorsal arch height. An embedded platform will be used to measure full-foot length. Ultrasound Machine A Philips IU22 ultrasound system (Philips Healthcare Solutions, Bothell, WA, USA) with a 12-5 MHz linear array transducer will be used Archercise Device 'Archercise' (patent pending PCT/AU2016/050437) will be connected to a graphical user interface (GUI) based computer program to control the sensor footplate, receiving, displaying and saving sensor data in real-time. Information on these materials will be provided in an online appendix of the research paper Procedures Foot Morphology Measures 1) Dominant foot will be determined by which foot is used to step up onto a platform and kick a ball 2) Dorsal arch height will be measured both sitting and standing using a digital height gauge 3) Full foot length: participants will be seated with their ankles, knees and hips at 90 degrees with feet placed on an embedded platform to measure from mid-heel to longest toe tip Ultrasound Assessment The participant will have their US examination completed directly after answering their questionnaire A Philips IU22 ultrasound system (Philips Healthcare Solutions, Bothell, WA, USA) with a 12-5 MHz linear array transducer will be used on the dominant foot of the participant. Each participant will be allocated a coded number to be deidentified on data. Two intrinsic foot muscles Abductor Hallucis (AbH) and Extensor Digitorum Brevis (EDB) cross-sectional areas will be evaluated in both the longitudinal and transverse planes. Participants will be seated on a raised examination table with their leg relaxed and knee flexed 90 degrees. Assistance will be provided with any movements on and off the table, and participants will be informed when the electronic table will move to prevent discomfort and falls. Pillows will also be provided on the table for comfort and stability. The participant's foot will be stabilised on the researcher's lap, with the ankle relaxed and the plantar aspect of the foot facing towards the ground. Appropriate bony anatomy will be palpated to identify the correct location of the intrinsic foot muscles of interest, such as the navicular tubercle and the medial sesamoid bone. Ultrasound gel is placed between the transducer and the foot to remove air artefacts and ensure good contact with the anatomy. Once the thickest part of the muscle is identified, the transducer will be rotated at 90 degrees at 50% of the transducer length perpendicularly to the muscle to capture its maximal cross-sectional area. The cross-sectional area will then be determined using the manual trace tool function of the ultrasound system around the circumference of the muscle cross-section. Finally, the thickness will be measured using the calliper function. Repeated measurements at the exact location will be taken to ensure the accuracy and reliability of measures. Biofeedback Device Assessment Participants will then be moved to the Biofeedback device assessment station directly after their US examination 'Archercise' (patent pending PCT/AU2016/050437) will be connected to a graphical user interface (GUI) based computer program to control the sensor footplate, receiving, displaying, and saving sensor data in real-time. This will be used to determine intrinsic foot muscle performance and surrogate measures of strength. The testing procedures will use a previously developed protocol (Latey, 2018). Latey, P. (2018). Measuring and managing foot muscle weakness. Retrieved from http://hdl.handle.net/2123/19174 Available from The University of Sydney Sydney eScholarship database. Participants will be seated with knees flexed 90 degrees, double leg stance. The dominant foot will be placed on the biofeedback device with toes and heels on the appropriate sensors and the foot's arch supported under the device's bladder. The bladder of the device will be inflated under the arch, and the participants will be asked to maintain contact with the toe and heel pressure sensors while performing the arch exercises to the best of their ability. Four exercises will be undertaken. Data capture and exercise sequence will be 10 seconds preparation, 10 seconds test time and 10 seconds end (total 30 seconds). The endurance arch lift sequences will involve 10 seconds preparation, 60 seconds test time and 20 seconds end (total 90 seconds) 1. Speed: Sequential isotonic muscle contractions to elevate and lower the arch in as large a range as possible and as quickly as possible. 2. Arch Elevation: Gradual isotonic concentric contraction of the foot arch muscle to lift the arch as high as possible 3. Arch Lowering: Pre-test arch elevation, then a gradual isotonic eccentric contraction of the foot arch muscle to lower the arch. 4. Endurance: Elevate the arch and maintain that controlled elevation in an isometric contraction of the foot and arch muscles. Participants will visualise the data continuously during the exercises, with data points depending on their performance. Who provided Sonographer 20+ years experience Physiotherapist and Pilates Instructor 20+ years experience Diagnostic Radiographer + medical student 6+ years experience When and how much The intervention will be delivered over one session. This session will take approximately one hour to complete all components. Where Ultrasound Lab at The University of Sydney Where the Ultrasound Machine and Archercise Biofeedback device will be kept and used. Tailoring N/A Modifications N/A How Well N/A