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Standardised classification system for bespoke thermoplastic ankle foot orthoses.

N Eddison1, A Healy2, D Buchanan3

  • 1Centre for Biomechanics and Rehabilitation Technologies, School of Life Sciences and Education, Staffordshire University, Leek Road, Stoke-on-Trent ST4 2DF, United Kingdom; The Royal Wolverhampton NHS Trust, New Cross Hospital, Wednesfield Road, Wolverhampton WV10 0QP, United Kingdom.

Foot (Edinburgh, Scotland)
|August 29, 2022
PubMed
Summary

This study evaluates a new, standardized way to categorize custom-made plastic leg braces. By testing how consistently experts identify different brace types, the researchers found that their system is highly reliable and easy to use. This tool helps clinicians and scientists communicate more clearly about the specific devices they study or provide to patients.

Keywords:
Ankle foot orthosesClassification systemsEvidence based medicineOrthoticsTerminologyorthotic device identificationclinical reliability studyrehabilitation technology standardsorthotics terminology framework

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Area of Science:

  • Rehabilitation medicine and thermoplastic ankle foot orthoses classification research
  • Clinical orthotics and prosthetics engineering

Background:

Ambiguity in describing custom medical braces hinders consistent clinical communication and research reporting. No standardized terminology currently exists to categorize these devices based on their specific structural and functional features. This lack of uniformity complicates comparisons across different patient cohorts and treatment protocols. Prior research has shown that inconsistent descriptions lead to confusion among healthcare providers and technical staff. That uncertainty drove the development of a structured framework for identifying these orthotic devices. This paper addresses the need for a reliable method to classify bespoke thermoplastic ankle foot orthoses. The authors aim to provide a common language for professionals involved in orthotic care. This initiative seeks to improve the quality of evidence-based practice through better documentation and reporting standards.

Purpose Of The Study:

The researchers aimed to validate a new classification system designed for bespoke thermoplastic ankle foot orthoses. This project addresses the lack of a uniform method for describing these custom-made medical devices. Current descriptive practices often suffer from significant ambiguity, which hinders effective communication among healthcare teams. The authors sought to create a structured approach based on the specific design and function of each orthosis. They intended to test whether this framework could provide consistent results across different observers. By establishing this tool, the team hoped to improve the accuracy of documentation in both clinical and research environments. This study was motivated by the need for reproducible data in the field of orthotic care. The investigation ultimately seeks to support the development of more robust evidence-based practices through standardized reporting.

Main Methods:

The investigators designed a reliability study to validate a new framework for categorizing custom orthotic devices. They recruited sixty-three experts, including clinicians, researchers, and technicians, to participate in an online assessment. These individuals evaluated thirty-six distinct photographs of various orthoses using the proposed criteria. A follow-up session occurred two weeks later with fifty-three of the original participants to measure consistency. The team calculated Fleiss' kappa statistics to quantify both inter-observer and intra-observer agreement levels. Participants also completed surveys regarding the clarity, utility, and ease of use of the tool. This review approach synthesized data from both the quantitative reliability scores and the qualitative feedback provided by the experts. The study design ensured that the validation process accounted for diverse professional perspectives within the orthotics field.

Main Results:

The study achieved high reliability scores, with a mean inter-observer Fleiss' kappa of 0.932. Intra-observer agreement reached a mean value of 0.944, demonstrating strong consistency over the two-week testing period. Key findings from the literature indicate that 98.3% of the participants rated the system as easy to use. Furthermore, 85.7% of the experts stated they would incorporate this method into their professional practice. The data show that 90.5% of the participants perceived the classification framework as clear. Additionally, 84% of the respondents explicitly identified the system as a useful tool for their work. These results confirm that the proposed criteria are both reliable and well-received by experienced professionals. The findings suggest that the system effectively addresses the need for standardized terminology in orthotic care.

Conclusions:

The proposed framework demonstrates excellent reliability for categorizing custom-made thermoplastic ankle foot orthoses. High agreement scores among diverse observers suggest the system is robust for professional use. This tool effectively minimizes confusion when describing specific device designs in clinical or academic settings. Standardized terminology facilitates reproducible comparisons between different patient groups in future studies. The authors propose that this system supports the advancement of evidence-based orthotic care. Consistent reporting will likely improve the quality of future evaluations within the field. This classification method provides a clear, practical solution for professionals managing these complex medical devices. Adoption of this system may enhance communication across the multidisciplinary teams responsible for patient rehabilitation.

The researchers report that the system achieved a Fleiss' kappa of 0.932 for inter-observer agreement and 0.944 for intra-observer agreement. These high values indicate that different experts, as well as the same individual over time, consistently categorized the devices using the provided framework.

The study utilized an online questionnaire featuring thirty-six photographs of various thermoplastic ankle foot orthoses. This digital approach allowed sixty-three independent experts to evaluate the devices remotely, ensuring a broad assessment of the system's usability and clarity across different professional backgrounds.

The participants consisted of sixty-three healthcare professionals, researchers, and technicians. Their collective expertise in prescribing, fitting, reviewing, or manufacturing these devices was necessary to ensure the validation reflected real-world clinical and technical requirements for accurate orthotic identification.

The study relied on photographic data to represent the diverse range of bespoke thermoplastic orthoses. This visual medium served as the primary input for observers to apply the classification criteria, testing whether the system could accurately capture design features without requiring physical access to the devices.

Approximately 98.3% of the participants found the system easy to use, while 90.5% described the framework as clear. These measurements confirm that the design successfully balances technical precision with practical accessibility for the intended professional audience.

The authors suggest that this framework will reduce descriptive ambiguity in clinical practice. By providing a standardized language, the researchers propose that professionals can conduct more reproducible comparisons, which they claim is vital for future evaluations of evidence-based orthotic care.