Lower leg muscle strengthening does not redistribute plantar load in diabetic polyneuropathy: a randomised controlled trial

Tom Melai, Nicolaas C Schaper, T Herman Ijzerman, Ton Lh de Lange, Paul Jb Willems, Valéria Lima Passos, Aloysius G Lieverse, Kenneth Meijer, Hans Hcm Savelberg, Tom Melai, Nicolaas C Schaper, T Herman Ijzerman, Ton Lh de Lange, Paul Jb Willems, Valéria Lima Passos, Aloysius G Lieverse, Kenneth Meijer, Hans Hcm Savelberg

Abstract

Background: Higher plantar pressures play an important role in the development of plantar foot ulceration in diabetic polyneuropathy and earlier studies suggest that higher pressures under the forefoot may be related to a decrease in lower leg muscle strength. Therefore, in this randomised controlled trial we evaluated whether lower-extremity strength training can reduce plantar pressures in diabetic polyneuropathy.

Methods: This study was embedded in an unblinded randomised controlled trial. Participants had diabetes and polyneuropathy and were randomly assigned to the intervention group (n = 48) receiving strength training during 24 weeks, or the control group (n = 46) receiving no intervention. Plantar pressures were measured in both groups at 0, 12, 24 and 52 weeks. A random intercept model was applied to evaluate the effects of the intervention on peak pressures and pressure-time-integrals, displacement of center-of-pressure and the forefoot to rearfoot pressure-time-integral-ratio.

Results: Plantar pressure patterns were not affected by the strength training. In both the intervention and control groups the peak pressure and the pressure-time-integral under the forefoot increased by 55.7 kPa (95% CI: 14.7, 96.8) and 2.0 kPa.s (95% CI: 0.9, 3.2) over 52 weeks, respectively. Both groups experienced a high number of drop-outs, mainly due to deterioration of health status and lower-extremity disabilities.

Conclusions: Plantar pressures under the forefoot increase progressively over time in people with diabetic polyneuropathy, but in this study were not affected by strength training. Future intervention studies should take this increase of plantar pressure into account and alternative interventions should be developed to reduce the progressive lower extremity problems in these patients.

Trial registration: This study was embedded in a clinical trial with trial number NCT00759265.

Figures

Figure 1
Figure 1
Design, number of analyzed subjects and reasons for attrition. The numbers represent the subjects analyzed at different times of measurement (at t = 0, 12, 24 and 52 weeks), including attrition due to technical failure. The lost to follow-up includes the reason for drop-out, which was classified as related or unrelated to gait.
Figure 2
Figure 2
Estimated mean values over time for intervention (in black) and control groups (in white). (a-l). Represented outcome parameters are according to the final random intercept models (Table 2). Graphs have broken y-axes to improve readability. PP is peak pressure; PTI is pressure–time-integral; tCOP is center-of-pressure expressed as percentage of the stance phase for it to enter the forefoot; F/R-ratio is the forefoot to rearfoot PTI ratio. Significant time effects over 52 weeks and group differences are marked with: * = p ≤ 0.05, † = p ≤ 0.01, ‡ = p ≤ 0.001.

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