Equistasi® - Preliminary information report available in Italy

Technology and indications

Equistasi® is a registered CE-marked wearable Class I medical device that looks like a common plaster (10×20×0.5 mm ) but is composed by nanotechnology fibres able to transform the body temperature into mechanical vibratory energy (0.8 N, 9000 Hz), named focal vibration, which generates a variation of muscle length of max 0.02 mm.

The hospital that requested the technology intends to use it for the reduction of falls in patients with Parkinson’s disease. The device is currently indicated for use in patients with Parkinson’s disease, multiple sclerosis and athletes to achieve gait improvements, which are related to the optimisation of the neuromuscular system.

Diffusion of the technology in Italy

At present, no units of the device have been used across the country.

Comparators

The device is proposed in addition to standard physical rehabilitation therapy.

Preliminary evidence summary

Searches of secondary studies identified three relevant guidelines for the management of Parkinson’s disease but none of them mentions focal vibrations therapy.

Searches of primary studies identified five relevant studies on the Equistasi® device. One study was performed on healthy subjects and was then excluded. Of the remaining four studies, only one was available in full-text (Volpe D et al. PlosOne 2014; 9(11): e112065) while the others were conference abstracts. The study was a RCT on 40 patients with Parkinson’s disease; an active device was used in 20 patients while the other 20 had an inactive device. Both groups received physical rehabilitation therapy.

Searches of ongoing studies identified two studies, a single-arm study of 64 patients and a RCT of 126 patients. Only the first aims to assess the reduction of falls. Both studies are performed in Italy and expected to be completed between 2018 and 2020.

Conclusions

Even if the included study shows a reduction of falls among the patients in which the Equistasi® device was used, such results should be considered preliminary since the sample size was small. No definitive conclusions can be drawn given the available evidence.

See the full report in Italian here.

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