Focal Muscular Vibration in Patients With Severe Acquired Brain Injury
Brain Injuries, Spasticity, Muscle
About this trial
This is an interventional treatment trial for Brain Injuries
Eligibility Criteria
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.
Sites / Locations
- UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
G-FMV (Group Focal Muscular Vibration)
G-CON (Group Conventional)
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.
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...)