Effects of a Home-Based Foot–Ankle Exercise Program with Educational Booklet for Foot Dysfunctions in People with Diabetic Neuropathy: Results of the FOCA-II Randomized Controlled Clinical Trial

Abstract

Exercise rehabilitation and education are important strategies for preventing the progression of diabetic neuropathy-related musculoskeletal deficits. The purpose of this randomized controlled trial was to investigate the effect of an 8-week home-based foot–ankle exercise program using an educational booklet on clinical outcomes (foot muscle strength and functionality; functional balance; diabetic neuropathy symptoms and severity; tactile and vibratory sensitivities; plantar pressure distribution; and foot–ankle, knee, and hip biomechanics during gait). Fifty participants with neuropathy were randomly allocated into an intervention group (59.1 ± 6.4 years, 23.5 ± 4.8 kg/m2, males = 6, females = 19) that performed the exercises for 8 weeks and a control group (56.5 ± 9.4 years, 22.9 ± 3.6 kg/m2, males = 5, females = 20) that received usual care recommendations. Generalized estimating equation method and intention-to-treat approaches were adopted. No significant differences were found for any clinical outcome after 8 weeks. Heel contact area increased in the intervention group compared to controls (p = 0.043, mean difference = 2.7 cm) and heel peak pressure was increased in controls compared to intervention (group effect p = 0.020, mean difference = -64.16 kPa) at 8 weeks. Controls showed increased joint moments for the hip at heel strike (p = 0.007) and for the knee and hip at push off over 8 and 16 weeks (p < 0.001 and p = 0.009, respectively). Although the intervention is easy to perform and showed a good adherence (72%), home-based foot–ankle exercise programs are unlikely to sufficiently modify the main risk factors related to foot ulcers and to change foot–ankle kinematics and kinetics.