Focal Muscular Vibration in Patients with Severe Acquired Brain Injury

NCT05464160 | Completed

• 1 other identifier: 4237
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Reduction of spasticity, assessed by Modified Ashworth Scale (MAS)

  The Modified Ashworth Scale (MAS) is a scale for the assessment of spasticity consisting of 6 different categories, based on the score assigned in relation to the degree of perceived resistance to passive mobilization.

  Change from Baseline MAS at 3 weeks and at 6 weeks

Secondary Outcomes (8)

• Reduction of disability, assessed by Disability Rating Scale (DRS)

  Change from Baseline DRS at 3 weeks and at 6 weeks

• Reduction of disability, assessed by modified Barthel Index (mBI)

  Change from Baseline mBI at 3 weeks and at 6 weeks

• Reduction of pain, assessed by Faces Pain Scale (FPS)

  Change from Baseline FPS at 3 weeks and at 6 weeks

• Reduction of pain, assessed by Nociception Coma Scale-revised (NCS-r)

  Change from Baseline NCS-r at 3 weeks and at 6 weeks

• Reduction of pain, assessed by Critical-Care Pain Observational Tool (C-POT)

  Change from Baseline C-POT at 3 weeks and at 6 weeks

Study Arms (2)

G-FMV (Group Focal Muscular Vibration)

EXPERIMENTAL

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.

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

G-CON (Group Conventional)

ACTIVE COMPARATOR

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...)

Other: Conventional Rehabilitation

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.

G-FMV (Group Focal Muscular Vibration)

Conventional Rehabilitation 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...)

G-CON (Group Conventional)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

Related Publications (5)

• Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863.

  PMID: 31868686 BACKGROUND

• Lucente G, Valls-Sole J, Murillo N, Rothwell J, Coll J, Davalos A, Kumru H. Noninvasive Brain Stimulation and Noninvasive Peripheral Stimulation for Neglect Syndrome Following Acquired Brain Injury. Neuromodulation. 2020 Apr;23(3):312-323. doi: 10.1111/ner.13062. Epub 2019 Nov 14.

  PMID: 31725939 BACKGROUND

• Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.

  PMID: 20834043 BACKGROUND

• Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.

  PMID: 24842220 BACKGROUND

• Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.

  PMID: 22402727 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luca Padua, MD, PhD

  Fondazione Policlinico Universitaria A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 19, 2022
• Study Start: October 15, 2021
• Primary Completion: July 8, 2022
• Study Completion: October 31, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)