Focal Muscular Vibration to Treat Upper Limb Spasticity in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Spasticity following stroke is one of the most debilitating conditions and has a negative
      influence on the autonomy and quality of life, and greatly worsens the patient's degree of
      disability. Focal muscular vibration (FMV) is a non-invasive technique to treat spasticity.
      Has been showed the positive effects of FMV on spasticity in stroke subjects. FMV has been
      investigated on the antagonist muscle, as well as directly on the spastic muscle, showing in
      both cases a significant reduction in spasticity. However, isn't unclear which is the most
      effective in the treatment of spasticity.

      The objective of the study is to evaluate the efficacy of FMV of the muscles of the upper
      limb in subjects with subacute stroke, comparing the effects obtained by treating the spastic
      muscles directly versus to those obtained by treating the respective antagonist muscles.
    

Detailed description: 
      Stroke is the major cause of permanent disability with an incidence in Italy of 293 affected
      persons per 100,000 inhabitants. The onset of spasticity following stroke (20-46%) is one of
      the most disabling conditions and has a negative influence on the patient's autonomy and
      quality of life.

      The development of spasticity during the rehabilitation process of these patients is a very
      limiting factor for the functional recovery of the affected side. The onset of spasticity
      considerably worsens the patient's degree of disability.

      Focal muscular vibration (FMV) is a non-invasive technique to treat spasticity. Has been
      showed the positive effects of FMV on spasticity in stroke subjects.

      Introduced by Hagbarth and Eklund at the end of the 1960s, it is based on the tonic-vibratory
      reflex. Based on this mechanism, some authors suggest that the FMV should be applied to the
      antagonist muscle in order to obtain a significant reduction in spasticity. However the
      literature shows a reduction in spasticity through the application of FMV directly on the
      spastic muscle. These effects seem to be related to the stimulation of cortical motor areas.
      Nevertheless, it remains unclear which approach is most effective in treating of spasticity.

      Stroke is a very common pathology, as well as a rehabilitative and social problem which also
      affects welfare. Considering prevalence of spasticity in stroke patients and the effects on
      their functional recovery, it is important to identify the most effective treatment to
      guarantee a more suitable rehabilitation process. In addition to this, it is worth
      remembering that FMV is less invasive and has lower costs than botulinum toxin, the current
      gold standard in the treatment of spasticity.

      The objective of the study is to evaluate the efficacy of FMV of the muscles of the upper
      limb in subjects with subacute stroke, comparing the effects obtained by treating the spastic
      muscles directly versus to those obtained by treating the respective antagonist muscles.
      Specifically, the two approaches will be compared on: (i) the reduction of the degree of
      spasticity, assessed by clinical scales and with an instrumental protocol; (ii) motor
      performance of the patient, using a robotic system; (iii) pain reduction.
    

Intervention name(s): FMV_flex; FMV_ext
Intervention type(s): Device; Device
Intervention description(s): Fisiocomputer EVM (Endomedica, Italy) for application of FMV to flexor muscles of the upper limb (brachial biceps and carpal flexors).; Fisiocomputer EVM (Endomedica, Italy) for application of FMV to extensors muscles of the upper limb (triceps brachial and carpus extensors).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Upper limb; Rehabilitation; Focal Muscular Vibration