Clinical Topic

This Clinical Knowledge Summary (CKS) presents suitable clinical outcome measures to assess post-stroke orthotic management, the classification of measures in terms of the International Classification of Functioning, Disability, and Health (ICF), and the determination of effect sizes.

Background Information

While many systematic reviews have been published on outcome measures in stroke rehabilitation, these have not focused on clinical outcomes germane to lower limb orthotic management. This is an important distinction as the utility of a given outcome measure is ultimately dependent on its sensitivity to the changes associated with the target intervention. The classification of such measures within the International Classification of Functioning, Disability, and Health (ICF) ensures comprehensive outcomes assessment.

Given that the range of outcomes that have been used to validate the efficacy of orthotic interventions report their findings across a spectrum of units (i.e., meters, seconds, meters/second, etc.), the comparison between the utility of one outcome against another can be considered using the construct of effect size. Calculations of effect size are unitless and allow for direct comparisons between measures in different units. This facilitates a comparative analysis of which measures are most likely to detect the differences associated with a lower limb orthotic intervention.

The ICF is a globally accepted framework for monitoring and describing health outcomes and changes in health status from a broad biopsychosocial perspective.¹ This model facilitates the consideration of health in terms of the body's structure and function, the activities an affected individual is able to engage in, and their ability to participate in the world around them. Choosing measures from across the domains of the ICF ensures that the different elements of health, function, and disability are ultimately considered.

Clinical Practice Implications

Appropriate use of outcome measures in stroke rehabilitation is central to good clinical practice. The use of such measures is recognized as a means of monitoring patient status, assessing the effectiveness of an intervention, and contributing to the quality of care provided to patients. Given the overwhelming number of outcome measures available, it can be difficult to determine the most appropriate measure to apply in a clinical setting to measure the efficacy of orthotic interventions.

The target population in this exercise consisted of adult stroke survivors that utilized some level of lower limb orthoses. While these were predominantly ankle-foot-orthoses (AFOs), they also included foot orthoses, knee orthoses, knee-ankle-foot-orthoses, and functional electrical stimulation. Studies were considered if one type of orthotic intervention was compared against the absence of an orthosis or another design of orthotic devices. Outcomes were limited to those measures that can be readily performed in a clinical setting and excluded measures requiring instrumented analysis.

The authors identified 48 different outcome measures suitable for clinical application within the target population. Descriptions of these measures and instructions on how to apply them can be found via these resources:

• https://www.physio-pedia.com/Category:Outcome_Measures
• https://www.sralab.org/rehabilitation-measures.

The reviewed findings suggest that the most frequently applied outcomes measures were the 10-meter walk test (10 MWT)² and the timed-up-and-go test (TUG).³ The outcome measures that recorded large effect sizes in two or more studies were the 10 MWT, Functional Reach Test (FRT)^4, and Physiological Cost Index.⁵ The measure with the most promising performance in terms of its effect size was the 10MWT, with six of 18 studies recording large or very large effect sizes. By contrast, only one of 16 studies reporting the TUG identified a large or very large effect size, and none of the seven studies reporting on the six-meter walk test were classified as large or very large. While less utilized, the FRT was associated with large or very large effect sizes in two of three available studies. Large or very large effect sizes support the position that these measures are sensitive enough to quantify improvements associated with orthotic interventions in this target population.

Notably, most studies with large or very large effect sizes compared either an orthosis condition to a no orthosis condition or investigated the effects of an orthosis over time. Large effect sizes were rarely recorded in studies comparing two orthosis conditions. This suggests the need for alternate outcome measures that are sensitive enough to detect the more subtle differences in performance associated with different orthotic designs.

The most common ICF domain represented in outcomes assessment was measures of mobility. The limited number of studies using outcome measures representing other ICF domains such as participation may reflect a rather narrow perspective of the effects that orthoses may have on health and functioning.

Evidence

This systematic review comprised electronic searches in PubMed, Cochrane, Web of Science, CINAHL, Scopus, and Embase databases from inception through May 2020. Eighty-eight articles underwent full-text review. Fifty-four articles were included in the review.

Eligibility criteria for inclusion were the English language, peer-reviewed articles including randomized controlled trials, case-control studies, cohort studies, case series studies, and qualitative studies. Articles were only included if they investigated lower limb orthotic devices as an intervention.

All studies were assessed for methodological quality by both authors using the relevant standardized critical appraisal tool from the Joanna Briggs Institute. Minimum quality standards were established for inclusion in the review.

1. World Health Organization. Towards a common language for functioning, disability and health. Geneva (Switzerland): ICF; 2002
2. Collen F, Wade D. et al. Mobility after stroke: reliability of measures of impairment and disability. Disabil Rehabil. 1990;12(1);6-9.
3. Flansbjer UB, Holmback AM, et al. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005;37(2):75-82.
4. Outermans JC, van Pepper RP, et al. Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Clin Rehabil. 2010;24(11):979-987.
5. Danielsson A et al. Measurement of energy cost by the Physiologic Cost Index in walking after stroke. Arch Phys Med Rehabil. 2007;88(10):1298-1303.

Reference for Full Systematic Review

Ramstrand N, Stevens PM. Clinical outcome measures to evaluate the effects of orthotic management post-stroke: a systematic review. Disability and Rehabilitation. 2021 Jan 12:1-20.

Conflicts of Interest

The authors declare no conflicts of interest.

Acknowledgments

This effort was funded by the American Academy of Orthotists and Prosthetists.

Suggested Citation

Ramstrand N, Stevens PM. American Academy of Orthotists and Prosthetists (AAOP) Clinical Knowledge Summary: Clinical outcome measures to evaluate the effects of orthotic management post-stroke. Bethesda, MD. 2021.

Date of Publication: 4/12/2021