MedTrace Logo

Focal Muscular Vibration in Patients with Severe Acquired Brain Injury

NCT05464160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

  • Brain Injuries
  • Spasticity, Muscle

Interventions

DEVICE

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

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.

OTHER

Conventional Rehabilitation

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...)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Luca Padua, MD, PhD · Fondazione Policlinico Universitaria A. Gemelli IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-07-08
Completion
2024-10-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464160 on ClinicalTrials.gov