BACKGROUNDS: Different and new approaches have been proposed to prevent the risk of falling of elderly people, particularly women. AIMS: This study investigates the possibility that a new protocol based on the focal mechanical muscle vibration may reduce the risk of falling of elderly women. METHODS: A pragmatic randomized controlled triple-blind trial with a 6-month follow-up after intervention randomized 350 women (mean age 73.4 years +/- 3.11), members of local senior citizen centers in Rome, into two groups: vibrated group (VG) and control group (CG). For VG participants a mechanical vibration (lasting 10 min) was focally applied on voluntary contracted quadriceps muscles, three times a day during three consecutive days. CG subjects received a placebo vibratory stimulation. Subjects were tested immediately before (T0) and 30 (T1) and 180 (T2) days after the intervention with the Performance-Oriented Mobility Assessment (POMA) test. All subjects were asked not to change their lifestyle during the study. CG underwent sham vibratory treatment. RESULTS: While CG did not show any statistically significant change of POMA at T1 and T2, VG revealed significant differences. At T2, about 47% of the subjects who completed the study obtained the full score on the POMA test and about 59% reached the full POMA score. CONCLUSIONS: The new protocol seems to be promising in reducing the risk of falling of elderly subjects.

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