CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05464160
NCT05464160N/ACompleted

Focal Muscular Vibration in the Intensive Treatment of Spasticity in Patients with Severe Acquired Brain Injury

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·interventional·Posted Jul 19, 2022·Updated Mar 20, 2025

In Brief

A clinical study evaluating Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy) and Conventional Rehabilitation for Brain Injuries and Spasticity, Muscle. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Severe acquired brain injury (sABI) is a group of disorders that cause long-term disability. Rehabilitation is essential to counteract bed immobilization, muscle failure, pain, and sensory deficits that can affect the clinical and rehabilitation pathway of these patients. Focal muscle vibration (FMV) is a tool that uses low-amplitude, high-frequency vibrations that when applied to muscle-tendon units. This technique, administered at specific frequencies, amplitudes and durations, can generate action potentials of the same frequency as the stimulus applied to the muscle or tendon. This makes it possible to activate selected afferent fibers and stimulate targeted brain areas with persistent effects over time (long-term potentiation). Regarding the effect of counteracting vibration spasticity, FMV is able to inhibit the reflex arc and induce reciprocal inhibition of functional agonist muscle. In addition, the strong proprioceptive stimulus generated by vibration is able to reach the primary motor and somatosensory cortex, enhancing cortical mechanisms that regulate co-contraction between agonist and antagonist muscles, thereby reducing muscle tone and joint stiffness. In many studies, this technique has been shown to be effective in reducing pain and joint stiffness by improving muscle contraction and motor control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 19, 2022
Enrollment StartOct 15, 2021
Primary CompletionJul 8, 2022
Study CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.0 years ago

Interventions

Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy)device

FMV will be applied 7 times per week for 3 weeks (21 total applications), using the "EVM EVO medical device" (Endomedica, Italy), applying an intensity of 100 Hz for a total of 23 minutes.

Conventional Rehabilitationother

Conventional treatment will focus on joint mobilization, muscle stretching, and neuromuscular facilitation activities, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive Neuromuscular Facilitation, etc...)