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Outcome Measures Toolkit

Lower Limb Orthotics Outcome Measures Toolkit 

Clinical Practice Resources

Summary

This toolkit identifies outcome measures (OMs) recommended for routine clinical assessment in adults receiving lower extremity orthoses from certified orthotists.

Table One

Recommended Patient-Report Outcome Measures

Core patient-reported tools recommended for routine clinical use in lower-limb orthotic care.

  • Falls and fall-related injuries (for example, 3-, 6-, or 12-month intervals)
  • Orthotic Patient-Reported Outcomes – Mobility (OPRO-M™)
  • Orthosis Comfort Score
  • EQ-5D-5L™
Table Two

Recommended Performance-Based Outcome Measures

Core performance-based tools recommended to assess function, walking ability, and mobility.

  • 10-meter Walk Test (10mWT)
  • Timed Up and Go (TUG)
  • 2-minute Walk Test (2MWT)

Purpose

This toolkit identifies outcome measures (OMs) recommended for routine clinical assessment in adults receiving lower extremity orthoses from certified orthotists.





Introduction

Evidence-based clinical practice promotes consistency between practitioners, demonstrates the value of the services provided, and improves quality of care. Use of OMs to objectively measure baseline status, the effectiveness of interventions, and inform clinical decision-making is a tenet of evidence-based practice.

Limited knowledge, resources, and time are major barriers to OM utilization in clinical practice.1 This document aims to address these barriers by recommending OMs that are most suitable for routine clinical care.

Orthotists are encouraged to administer a combination of these OMs during patient encounters to inform care and demonstrate intervention effectiveness and value. Administration of at least one OM is recommended at initial evaluation, at or shortly after orthosis delivery, and at regular follow-up appointments such as three months, six months, and one year.

Administration of all recommended measures at any given visit may not be necessary or feasible; however, systematic, objective, and thoughtful evaluation of the patient’s greatest unmet needs is encouraged.

Methods

This toolkit was developed by a work group within the Outcomes Research Committee of the American Academy of Orthotists and Prosthetists according to internal guidelines for development.2 Members consulted content experts and reviewed secondary knowledge sources in lower-limb orthotics research,3-5 including a 2021 scoping review of instruments used to assess quality of care for individuals with custom ankle-foot orthoses.6

OMs considered for the toolkit were drawn from measures routinely used in orthotics practice, measures with which members of the work group were familiar, and measures identified through multiple sources. OMs included in the toolkit were evaluated for their ability to measure select constructs of patient health, as defined by the International Classification of Functioning, Disability and Health (ICF).

The work group identified and reviewed 25 OMs used clinically or in research among adults with lower-limb paresis or deformity. Eight of these were patient-reported measures assessing patient perception or experience, three were clinician-reported measures assessing patient symptoms or function, and 14 were performance-based measures objectively assessing patient capacity while performing predefined activities.

It is important to note that none of the OMs has been validated specifically for assessing the effects of orthosis use, but rather for assessing safety, mobility, and function in patients with neurological conditions that commonly result in the need for orthoses.

The list of available OMs was reviewed with a focus on clinical feasibility and the presence or absence of psychometric data. Factors considered included predictive validity, patient safety, cost, licensing requirements, time burden, space, portability, ease of administration, current utilization trends, and anticipated acceptability by clinicians. Due to the lack of consistency in psychometric evaluation in the literature, direct comparison between measures was not attempted. Overall psychometric quality of OMs was subjectively considered by the work group.

To support the goal of widespread clinical adoption, development of a concise recommendation was prioritized. The work group was also sensitive to each OM’s potential for supporting intervention or reimbursement decisions and considered similar projects by international groups.7,8

The toolkit received input from an expert advisory panel consisting of orthotists, therapists, researchers, and other stakeholders and was approved by the Academy’s Research Council. It will be reviewed and updated in the future as relevant evidence and methods for OM selection emerge in lower-limb orthotics.

ICF Basis Set

CF Code Category Description
b280-b289 Pain
b455 Exercise tolerance
b810 Protective functions of skin
d230 Carrying out daily routine
d410 Changing basic body position
d415 Maintaining body position
d450 Walking
d455 Moving around
d465 Moving around using equipment
Table 3. Lower Limb Orthotics Outcome Measures Toolkit ICF Basis Set

Toolkit OM Recommendations

The recommended patient-report outcome measures for the orthotic treatment of adult individuals receiving lower-limb orthoses include:

  • Falls and fall-related injuries9 (for example, 3-, 6-, or 12-month intervals)
  • Orthotic Patient-Reported Outcomes – Mobility (OPRO-M™)10
  • Orthosis Comfort Score11
  • EQ-5D-5L™12

The recommended performance-based outcome measures for the orthotic treatment of adult individuals receiving lower-limb orthoses include:

  • 10-meter Walk Test (10mWT)13
  • Timed Up and Go (TUG)14
  • 2-minute Walk Test (2MWT)15

Practitioners are encouraged to include a combination of patient-report and performance-based mobility measures in evaluation of mobility, since patient perception may differ from functional capacity.

Functional capacity is known to vary over time and may be influenced by patient and environmental factors including orthosis comfort and fit, limb pain, fatigue, assistive-device use, transient impairments, or changes in health status. Consequently, when OM data changes, orthotists should consider other relevant factors to help explain the change.

For example, a reduction in patient-reported mobility measured with the Orthotic Patient-Reported Outcomes – Mobility (OPRO-M™) or observed mobility measured with the Timed Up and Go (TUG) test may be accompanied by a reduction in the Orthosis Comfort Score (OCS). That reduction in orthosis comfort could help explain the reduction in actual or perceived mobility.

Recommendations for Additional Research

The following OMs should be further investigated in research to evaluate psychometric properties or establish clinical interpretability with regard to orthosis use:

  • Modified Emory Functional Ambulation Profile (mEFAP)16
  • Functional Ambulation Categories (FAC)17
  • Patient-Specific Functional Scale (PSFS)18

Acknowledgements

The working group expresses thanks to members of the expert advisory panel: Stefania Fatone, PhD; Allen W. Heinemann, PhD; and Geoff S. Balkman, PhD.*

*This toolkit does not necessarily reflect the views of expert advisory panel members or their host institutions.

Suggested Citation

Citation Kannenberg A, Wilken J, Weber E. Outcomes Research Committee. American Academy of Orthotists and Prosthetists (AAOP). Outcome Measures Toolkit Summary: Lower Limb Orthotics. Bethesda, MD. 2024.

References

  1. Morgan SJ, Rowe K, Fitting CC, Gaunard IA, Kristal A, Balkman GS, Salem R, Bamer AM, Hafner BJ. Use of standardized outcome measures for people with lower limb amputation: a survey of prosthetic practitioners in the United States. Arch Phys Med Rehabil. 2022;103(9):1786-1797. doi: 10.1016/j.apmr.2022.03.009. Epub 2022 Apr 6.
  2. Klenow TD, Kaluf B, Wurdeman S. Outcome Measure Toolkit Guidelines. Bethesda, MD: American Academy of Orthotists and Prosthetists (AAOP); 2018.
  3. “How-To” Video Series. https://oandp.org/page/HowToVideos
  4. O’Connor J, McCaughan D, McDaid C, Booth A, Fayter D, Rodriguez-Lopez R, Bowers R, Dyson L, Iglesias CP, Lalor S, O’Connor RJ, Phillips M, Ramdharry G. Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey, and costing analysis. NHS National Institute for Health Research, Health Technology Assessment (HTA), Volume 20, Issue 55, July 2016. DOI 10.3310/hta20550. https://njl-admin.nihr.ac.uk/document/download/2003689
  5. McDaid C, Fayter D, Booth A, O’Connor J, Rodriguez-Lopez R, McCaughan D, Bowers R, Iglesias CP, Lalor S, O’Connor RJ, Phillips M, Ramdharry G. Systematic review of the evidence on orthotic devices for the management of knee instability related to neuromuscular and central nervous system disorders. BMJ Open. 2017;7:e015927. doi:10.1136/bmjopen-2017-015927.
  6. Fatone S, Jerousek S, Slater BCS, Deutsch A, LaVela SL, Peterson M, Soltys T, McPherson V, Heinemann AW. Identifying instruments to assess care quality for individuals with custom ankle foot orthoses: a scoping review. Arch Phys Med Rehabil. 2021;102:702-734. https://doi.org/10.1016/j.apmr.2020.06.029
  7. Brehm M, Bus SA, Harlaar J, Nollet F. A candidate core set of outcome measures based on the International Classification of Functioning, Disability, and Health for clinical studies on lower limb orthoses. Prosthet Orthot Int. 2011;35(3):269-277. DOI: 10.1177/0309364611413496.
  8. Van Duijnhoven E, Koopman FS, Ploeger HE, Nollet F, Brehm MA. Effects of specialist care lower limb orthoses on personal goal attainment and walking ability in adults with neuromuscular disorders. PLoS One. 2023;18(1):e0279292. https://doi.org/10.1371/journal.pone.0279292
  9. Lee J, Geller AI, Strasser DC. Analytical review: focus on fall screening assessments. PM&R. 2013;5:609-21. doi: 10.1016/j.pmrj.2013.04.001.
  10. Balkman GS, Morgan SJ, Amtmann D, Baylor C, Hafner BJ. Development of a candidate item bank for measuring mobility of lower limb orthosis users. PM&R. 2023;15(4):445-455. doi: 10.1002/pmrj.12916. Epub 2023 Feb 10.
  11. DeZeeuw KG, Dudek N. Orthosis Comfort Score: Establishing initial evidence of reliability and validity in ankle foot orthosis users. Prosthet Orthot Int. 2019;43(5):478-484. doi: 10.1177/0309364619866611. Epub 2019 Aug 5.
  12. EuroQol Office: EQ-5D-5L. https://euroqol.org. Accessed 8/22/2023.
  13. Salbach NM, O’Brien K, Brooks D, et al. Reliability, measurement error and sensitivity to change of time-limited walk tests in people with stroke: a systematic review. Cerebrovasc Dis. 2013;35:765.
  14. Tyson S, Connell L. The psychometric properties and clinical utility of measures of walking and mobility in neurological conditions: a systematic review. Clin Rehabil. 2009;23:1018-33. doi: 10.1177/0269215509339004. Epub 2009 Sep 28.
  15. Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting neurologic impairment. Arch Phys Med Rehabil. 2001;82(1):9-13. doi: 10.1053/apmr.2001.9396.
  16. Scrivener K, Sherrington C, Schurr K. A systematic review of the responsiveness of lower limb physical performance measures in inpatient care after stroke. BMC Neurol. 2013;13:4. doi: 10.1186/1471-2377-13-4.
  17. Geroin C, Mazzoleni S, Smania N, Gandolfi M, Bonaiuti D, Gasperini G, Sale P, Munari D, Waldner A, Spidalieri R, Bovolenta F, Picelli A, Posteraro F, Molteni F, Franceschini M; Italian Robotic Neurorehabilitation Research Group. Systematic review of outcome measures of walking training using electromechanical and robotic devices in patients with stroke. J Rehabil Med. 2013;45:987-96. doi: 10.2340/16501977-1234.
  18. Pathak A, Wilson R, Sharma S, Pryymachenko Y, Ribeiro DC, Chua J, Abbott JH. Measurement Properties of the Patient-Specific Functional Scale and Its Current Uses: An Updated Systematic Review of 57 Studies Using COSMIN Guidelines. J Orthop Sports Phys Ther. 2022 May;52(5):262-275. doi: 10.2519/jospt.2022.10727. Epub 2022 Feb 5.