Efficacy of Focal Muscular Vibration in the Treatment of Upper Limb Spasticity in Subjects With Stroke Outcomes: Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in Modified Ashworth Scale (MAS)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •first cerebral stroke
- •2 weeks up to 12 months post the acute event (subacute patients)
- •age between 35-80 years
- •single cortical or subcortical event
- •spastic paresis of the upper limb (Modified Ashworth Scale score ≥ 2)
- •ability to give written consent
- •compliance with the study procedures
Exclusion Criteria
- •comorbidities affecting the paretic upper limb (fractures, trauma or peripheral neuropathies)
- •cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
- •treatment with focal or systemic antispastic drugs (i.e. baclofen, thiocolchicoside, tizanidine).
Arms & Interventions
Group Flexors (A)
Group A was treated by applying FMV to the flexor muscles of the upper limb (brachial biceps and carpal flexors). Patients will be treated with FMV for three consecutive days: each session consisted of three sessions of 10 minutes each, interspersed with one minute of rest. A vibration frequency of 100 Hz has been applied, according to the literature.
Intervention: FMV_flex (Device)
Group Extensors (B)
Group b was treated by applying FMV to the extensors muscles of the upper limb (triceps brachial and carpus extensors). Patients will be treated with FMV for three consecutive days: each session consisted of three sessions of 10 minutes each, interspersed with one minute of rest. A vibration frequency of 100 Hz has been applied, according to the literature.
Intervention: FMV_ext (Device)
Outcomes
Primary Outcomes
Change in Modified Ashworth Scale (MAS)
Time Frame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.
Secondary Outcomes
- Change in Neuropathic Pain four Questions (DN4)(Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2))
- Change in ID Pain(Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2))
- Change in Neuropathic Pain Symptom Inventory (NPSI)(Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2))
- Change in Numerical Rating Scale (NRS)(Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2))
- Change in Motricity Index (MI)(Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2))
Investigators
Irene Giovanna Aprile
MD, PhD
Fondazione Don Carlo Gnocchi Onlus