Background: 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.
Objectives: 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.
Study Design: This is a prospective, observational study designed to establish initial evidence of validity and reliability for an outcome measure that assesses comfort.
Methods: 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).
Results: 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 < 0.05).
Conclusion: This study demonstrates initial evidence for the validity and reliability of the Orthosis Comfort Score in ankle foot orthosis users.
Clinical Relevance: 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.
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