Lower Limb Orthotics Outcome Measures Toolkit Summary

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 to assess quality of care for individuals with custom ankle-foot orthoses.⁵ OMs considered for the toolkit were drawn from OMs that are routinely used in orthotics practice, that members of the work group were familiar with, and considered from 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, Table 3).

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, 3 were clinician-reported measures assessing patient symptoms or function, and 14 were performance-based measures objectively assessing patient capacity while performing pre-defined activities. It is important to note that none of the OMs has been validated specifically for assessing the effects of orthosis use but for assessing safety, mobility, and function of patients with neurological conditions that typically result in the necessity to use orthoses.

The list of available OMs were reviewed with a focus on clinical feasibility and the presence or absence of psychometric data. Factors 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.

Further, 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. The work group also 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. The toolkit will be reviewed and updated in the future as relevant evidence and methods for OM selection emerge in lower-limb orthotics.

Toolkit OM Recommendations

The recommended Patient-Report Outcome Measures for the orthotic treatment of adult individuals with lower-limb loss or difference include:

• Falls and fall-related injuries⁹ (e.g. 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 prosthetic treatment of adult individuals with lower-limb loss or difference 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.

Further, 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 change in health status. Consequently, when OM data changes, orthotists should consider other relevant factors to explain this 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). This reduction in orthosis comfort could 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 regards 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. Heinmann, PhD, Geoff S. Balkman, PhD. This toolkit does not necessarily reflect the views of expert advisory panel members or their host institutions.

Suggested 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. In: 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. _{DMcDaid 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. Brit Med J 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. Identfying 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. Phys Med Rehabil 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. Phys Med Rehabil 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.}