Efficacy of Focal Muscular Vibration in the Treatment of Upper Limb Spasticity in Subjects With Stroke Outcomes: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Modified Ashworth Scale (MAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Change in Modified Ashworth Scale (MAS)
时间窗: 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.
次要结局
- 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))
研究者
Irene Giovanna Aprile
MD, PhD
Fondazione Don Carlo Gnocchi Onlus