Summary of the Device Evidence Compendium on Orthotics for WHO APL2 - Orthotic Devices

Purpose and Rationale 

This document forms part of the AT2030 programme’s contribution to the WHO Assistive Product List (APL) 2 development process, delivered by the International Society of Prosthetics and Orthotics (ISPO) in collaboration with the Global Disability Innovation Hub. Its purpose is to systematically synthesise existing evidence relating to priority prosthetic and orthotic devices, in order to: 

• Support transparent prioritisation of assistive products with the greatest potential health and participation impact. 

• Inform the development of WHO Assistive Product Specifications, clarifying expected outcomes, performance requirements, and risk considerations. 

• Make comparative, evidence‑based summaries accessible to policymakers, implementers, innovators, and service providers. 

The document is not intended as a clinical guideline or technology recommendation. Instead, it functions as an evidence scaffold: consolidating what is currently known about need, benefits, risks, and use patterns, while clearly identifying evidence gaps relevant to global health, particularly in low‑ and middle‑income settings. 

What the Document Contains 

The document provides structured evidence summaries across a wide range of externally worn orthotic devices, following a consistent framework aligned with WHO APL2 requirements. For each device category, it documents: 

• Product description and scope, aligned to WHO coding. 

• User populations and functional needs, with an emphasis on long‑term and chronic use. 

• Intended use and usage patterns, including fitting and contextual considerations. 

• Global need and prevalence, where evidence exists, including epidemiology of associated conditions. 

• Benefits, spanning functional performance, activities and participation, and (where available) quality of life. 

• Risks and adverse consequences, noting both physical and psychosocial factors as well as adherence challenges. 

• Other considerations, including access, service delivery implications, and research limitations. 

The evidence base is drawn predominantly from systematic reviews, meta‑analyses, and high‑quality narrative reviews, reflecting the focus on existing reviews of evidence rather than generating new primary data. 

Why This Work Matters 

Consistent with the original proposal, this work responds to a recognised gap: while prosthetics and orthotics are widely used and clinically essential, their evidence base is fragmented, inconsistently reported across device types, and often focused on high‑income contexts or a narrow subset of products. By consolidating evidence across multiple device categories and body regions, the document: 

• Enables WHO and partner stakeholders to make comparable, well evidenced decisions in APL 2 inclusion. 

• Supports innovators and manufacturers by clarifying what outcomes matter, rather than prescribing specific technologies. 

• Highlights system‑level issues such as adherence, long‑term use burden, and access to trained fitting services. 

• Makes explicit where evidence is limited, absent, or poorly generalisable, informing future research and consultation priorities.