Orthosis Comfort Score: Establishing initial evidence of reliability and validity in ankle foot orthosis users.

Abstract

Comfort of an orthosis is an important characteristic that is likely to dictate use of and satisfaction with a device. However, instruments to assess only orthosis user comfort do not exist. The Prosthetic Socket Fit Comfort Score, developed previously for prosthesis users, may be adapted to serve this purpose. This study's purpose was to assess the validity and reliability of the Orthosis Comfort Score, a self-report instrument adapted from the Prosthetic Socket Fit Comfort Score. This is a prospective, observational study designed to establish initial evidence of validity and reliability for an outcome measure that assesses comfort. Ankle foot orthosis users completed the Orthosis Comfort Score and two validated patient satisfaction questionnaires. An orthotist documented an assessment of fit. Post-visit Orthosis Comfort Scores were documented after the appointment and 2-4 weeks later. Orthosis Comfort Scores were compared to the patient satisfaction questionnaires, assessment of fit and orthosis use (hours per week). There were 46 study participants. Orthosis Comfort Scores had a moderate positive correlation with their orthotist's assessment of fit, very strong positive correlations with patient satisfaction questionnaires and fair positive correlation with orthosis use (all correlations p < 0.05). This study demonstrates initial evidence for the validity and reliability of the Orthosis Comfort Score in ankle foot orthosis users. The Orthosis Comfort Score is a simple patient-reported outcome measure that can be readily incorporated into clinical practice or research study to obtain a rapid assessment of comfort. It can be used to facilitate communication about device fit, evaluate comfort over time and/or assess changes in comfort with a new device.