A comfort assessment of existing cervical orthoses

Purpose: identify location and intensity of discomfort experienced by healthy participants wearing cervical orthoses. Method: convenience sample of 34 healthy participants wore Stro II, Philadelphia, Headmaster, and AspenVista® cervical orthoses for four-hour periods. Participants reported discomfort level (scale 0-6) and location. Results: participants reported mean discomfort for all orthoses over the four-hour test between ‘a little discomfort’ and ‘very uncomfortable’ (mean discomfort score=1.64, SD=1.50). Seven participants prematurely stopped tests due to pain and six reported maximum discomfort scores. Significant linear increase in discomfort with duration of wear was found for all orthoses. Significantly less discomfort was reported with Stro II than Headmaster and Philadelphia. Age correlated with greater perceived discomfort. Orthoses differed in the location discomfort was experienced. Conclusion: existing cervical orthoses cause discomfort influenced by design and duration of wear with orthoses' design the more significant factor. This work informed the design of a new orthosis and future orthoses developments

Assessment of the Sheffield Support Snood, an innovative cervical orthosis designed for people affected by neck weakness

The aim of this study was to quantify the biomechanical features of the Sheffield Support Snood (SSS), a cervical orthosis specifically designed for patients with neck weakness. The orthosis is designed to be adaptable to a patient’s level of functional limitation using adjustable removable supports, which contribute support and restrict movement only in desired anatomical planes. Methods: The SSS was evaluated along with two commercially available orthoses, the Vista and Headmaster. The orthoses were compared in a series of flexion, extension, axial-rotation and lateral bending movements. Characterisation was performed with twelve healthy subjects with and without the orthoses. Two Inertial-Magneto sensors, placed on forehead and sternum, were used to quantify the neck range of motion (ROM). Findings: In its less rigid configuration, the SSS was effective in limiting movements only in the desired planes, preserving free movement in other planes, whereas the headmaster was only effective in limiting the flexion. The percentage of ROM achieved with the SSS in its rigid configuration is equivalent (P > 0.05, effect size < 0.4) to that achieved with the Vista, both in trials performed reaching the maximum amplitude (ROM reduction: 25%-34% vs 24%-47%) and at maximum speed (ROM reduction: 24%-29% vs 25%-43%). Interpretation: The SSS is effectively adaptable to different tasks and in its rigid configuration offers a support comparable to the Vista, although it has a less bulky structure. The chosen method is suitable for the assessment of ROM movements while wearing neck orthoses and easily translatable in a clinical context

Usability Engineering in Practice: Developing an intervention for post-stroke therapy during a global pandemic

This paper provides an overview of the usability engineering process and relevant standards informing the development of medical devices, together with adaptations to accommodate situations such as global pandemics where use of traditional face-to-face methods is restricted. To highlight some of those adaptations, a case study of a project developing a novel electronic rehabilitation device is referenced, which commenced in November 2020 amidst the COVID-19 pandemic. The Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) project, led by Sheffield Teaching Hospitals NHS Foundation Trust (STH), aimed to design, manufacture and trial an intervention for use to treat upper arm spasticity after stroke. Presented is an outline and discussion of the challenges experienced in developing the SHAPES health technology intended for at-home use by stroke survivors and in implementing usability engineering approaches. Also highlighted, are the benefits that arose, which can offer easier involvement of vulnerable users and add flexibility in the ways that user feedback is sought. Challenges included: restricted travel; access to usual prototyping facilities; social distancing; infection prevention and control; availability of components; and changing work pressures and demands. Whereas benefits include: less travel; less time commitment; and greater scope for participants with restricted mobility to participate in the process. The paper advocates a more flexible approach to usability engineering and outlines the onward path for development and trialling of the SHAPES technology