RESUMEN
INTRODUCTION: Frail older people with diabetes often present with or develop walking impairments, in part due to lower-limb sensory-motor neuropathy. Several studies suggest a possible improvement of balance control using somatosensory stimulation. We undertook a novel randomized control trial, the aim of which was to observe whether use of this device for 1 month improves walking speed as measured in the 10-m fast walking speed test standardized to body size at month 1 (M1) (FWS). Secondary outcomes were the differences between intervention (VS) and control (C) in the 10-m normal walking speed test, step length, short physical performance battery, timed up and go test, and posturographic measures. METHODS: Subjects were aged ≥ 70 years and had had type 2 diabetes for at least 2 years. The intervention (VS) at home consisted of 22-min daily vibrating sequences with noise intensity set at 90% of the tactile threshold for each foot. The same device was used in group C but noise was set to 0. Compliance was retrieved from the device. RESULTS: Among 56 subjects, 27 were in the VS group and 29 in the C group; 35 subjects were frail, 15 were prefrail ,and 6 were non-frail. Bilateral neuropathy was present in 17 subjects. More than half of sessions were done in 36 subjects with no discernible difference according to intervention. At M1 there were no discernible differences in FWS between the groups [VS: 0.96 (0.53) cm s-1 cm-1, C: 0.94 (0.47) cm s-1 cm-1]. There were also no discernible differences in other outcomes, irrespective of the presence of bilateral neuropathy. CONCLUSION: In a cohort of frail, prefrail, or non-frail older subjects with diabetes, a 1-month intervention using a vibrating insole device did not alter measures of walking speed and related measures. Larger studies with longer term and different stimulation protocols are required to test this hypothesis more fully.
RESUMEN
The application of a stochastic mechanical noise has been shown to improve plantar touch sensitivity in patients with diabetic neuropathy and balance control. The present work aimed to test the feasibility of a specially designed vibrating device on gait and posture in older patients with type 2 diabetes with special interest on potential side effect (sensation of needles or tingling, dizziness or falls) before further investigations. For this, gait and balance tests were performed in 29 older out and in-patients (mean age 84 years, Barthel index ≥ 60/100) immediately before and after a 19 min plantar vibrating sequence, as well as 15 min after. These tests included posturographic measurements under eyes closed and static conditions and clinical gait tests (Short Physical Performance Battery and Timed-Up and Go tests). The results showed that no side effect was measured immediately, 15 min and up to 30 days after the vibration sequence. Besides, postural and clinical gait tests showed global positive effects at immediate and 15 min follow-up. Further investigation are now necessary to determine whether a daily stimulation sequence for a given time would lead to long-term positive effects on daily living (NCT01654341; https://clinicaltrials.gov/ct2/show/NCT01654341).