A non-invasive biomechanical device and treatment for patients following total hip arthroplasty: results of a 6-month pilot investigation

Ganit Segal, Yaron Bar-Ziv, Steven Velkes, Vadim Benkovich, Gilad Stanger, Eytan M Debbi, Ronen Debi, Amit Mor, Avi Elbaz, Ganit Segal, Yaron Bar-Ziv, Steven Velkes, Vadim Benkovich, Gilad Stanger, Eytan M Debbi, Ronen Debi, Amit Mor, Avi Elbaz

Abstract

Background: The purpose of the study was to examine the effect of a foot-worn biomechanical device on the clinical measurements and gait patterns of patients with total hip arthroplasty (THA).

Methods: Nineteen patients, up to 3 months post-THA, were enrolled to the study. Patients underwent a computerized gait analysis to calculate spatiotemporal parameters and completed the Western Ontario and McMaster Universities osteoarthritis index and the SF-36 health survey. Patients then began therapy with a non-invasive foot-worn biomechanical device coupled with a treatment methodology (AposTherapy). Patients received exercise guidelines and used the device daily during their regular activities at their own environment. Follow-up examinations were conducted after 4, 12, and 26 weeks of therapy. Repeated measures ANOVA was used to evaluate changes over time. The clinical significance of the treatment effect was evaluated by computing the Cohen's effect sizes (ES statistic).

Results: After 26 weeks of therapy, a significant improvement was seen in gait velocity (50.3%), involved step length (22.9%), and involved single limb support (16.5%). Additionally, a significant reduction in pain (85.4%) and improvement in function (81.1%) and quality of life (52.1%) were noted.

Conclusions: Patients following THA demonstrated a significant improvement in gait parameters and in self-assessment evaluations of pain, function, and quality of life. We recommend further RCTs to examine the effect of this therapy compared to other rehabilitation modalities following THA and compared to healthy matched controls.

Trial registration: Clinical trial registration number NCT01266382.

Figures

Figure 1
Figure 1
Apos System. (A) Biomechanical device comprising of two individually calibrated elements and a foot-worn platform. The elements are attached under the hindfoot and forefoot regions of the platform. (B) The biomechanical elements are available in different degrees of convexity and resilience. (C) The specially designed sole of the platform includes two mounting rails and a positioning matrix to enable flexible positioning of each biomechanical element.
Figure 2
Figure 2
Changes in gait velocity, step length, and single limb support following 6 months of AposTherapy. A significant improvement was seen in all gait variables. All P values were <0.05. SLS, single limb support; GC, gait cycle.

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