Children’s Off-the-Shelf Stability Therapeutic Footwear: a mixed method analysis to define their design and purpose.

Footwear is commonly used within the first line of clinical intervention option in children with mobility impairments. It has been used in many roles to assist mobility, from correction of congenital skeletal alignment to support of foot and ankle structures. However, an evidence-based consensus of the different roles and types of clinical footwear has never been achieved. Off-the-shelf stability therapeutic footwear (OSSTF) is a range of commercial clinical footwear that is not bespoke but is taken from stock that is available immediately. Manufacturers propose that this footwear assists stability in gait for mobility-impaired children, however, as identified through scoping and systematic reviews within this thesis this footwear has not been defined. There is a paucity of information on the terms and definitions to identify this footwear and for what mobility impairments it should be prescribed including the purpose of treatment. Also, the design characteristics that will influence its effect as an intervention are not defined. A lack of uniform understanding of intervention leads to inconsistent practice for all stakeholders, clinicians, researchers, and manufacturers.

This thesis has utilised a mixed method approach across a series of studies to provide consistency to the disparate nature of the evidence base concerning footwear interventions, with a specific focus on OSSTF. A conceptual framework for children’s clinical footwear has been established with definitions for therapeutic footwear and its groups/subgroups provided. Assessment of the design and material characteristics of a range of available OSSTF informed a Delphi study which provided expert consensus on prescription criteria, purpose, and clinical outcomes for OSSTF. It also provided consensus on salient design characteristics of OSSTF to assist stability and ergonomic function. The effect of these design characteristics were then quantitatively tested in-situ on footwear using a novel mechanical testing methodology. The testing demonstrated which design characteristics had the greatest effect on the stiffness of OSSTF to simulated foot and ankle movements. Building on these results a preliminary assessment tool to assist clinicians in identifying and scoring OSSTF footwear was developed.

This collective work in this thesis has provided consistent terms and definitions to define and group children’s therapeutic footwear. It has also provided an expert consensus preliminary criteria prescription for OSSTF and objectively identified how this footwear will act as an intervention. Although further in-vivo testing of the effects of OSSTF on children identified from the prescription criteria is still required, the conceptual basis of OSSTF established in this thesis will inform clinical decision-making, research reporting and manufacturing of OSSTF for children living with mobility impairments.