Focal Muscular Vibration in Patients with Severe Acquired Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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The present study aims to analyze the effects of focal muscle vibration in patients with sABI. This study is innovative for the setting, as it will take place for the first time within a neurorehabilitation hospital ward, for the intensity of the treatment as patients will undergo daily treatment sessions, for longer periods than protocols so far in the scientific literature. Finally, the cortical effects of the vibratory stimulus will be analyzed through the analysis of cortical neurophysiological correlates

Conditions

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Brain Injuries Spasticity, Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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G-FMV (Group Focal Muscular Vibration)

Patients allocated in the G-FMV, in addition to conventional rehabilitation treatment, will be treated for 3 weeks with FMV, applied to the upper and/or lower limb, depending on the clinical status.

The G-FMV will perform the treatment at a frequency of 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. Specifically, four different trains of stimulation lasting 5 minutes each will be performed, interspersed with 1 minute of rest (20 minutes of treatment + 3 minutes of rest). FMV will be applied on agonist (major spasticity) muscles of the lower limb and/or upper limb, either single-district or multiple-district, according to clinical evidence of intervention. Stimulation will be conducted in a stand-alone session as an adjunctive modality to the rehabilitation project of physiotherapy and occupational therapy.

Group Type EXPERIMENTAL

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

Intervention Type 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.

G-CON (Group Conventional)

Patients allocated in the G-CONwill be treated for 3 weeks by specific conventional rehabilitation based on the clinical status.

The G-CON will carry out the normal physiotherapy and occupational therapy rehabilitation treatment, as per the rehabilitation project, for an equal total treatment time to the G-FMV. 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...)

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type OTHER

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...)

Interventions

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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.

Intervention Type DEVICE

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...)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18-75 years
* Picture of subacute sABI (20 days to 6 months after the acute event), of any etiology (traumatic, vascular, metabolic)
* Presence of spasticity in the affected limb as assessed by the Modified Ashwort Scale (MAS) ≥ 1+

Exclusion Criteria

* recent treatment with botulinum toxin (within 3 months);
* ongoing treatment with systemic muscle relaxant drugs (baclofen, tizanidine, benzodiazepines);
* deep vein thrombosis;
* central/peripheral accesses ipsilateral to the limb(s) to be treated;
* oncological diseases;
* epilepsy;
* open skin lesions or local infections.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No