Focal Muscular Vibration in the Intensive Treatment of Spasticity in Patients with Severe Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Reduction of spasticity, assessed by Modified Ashworth Scale (MAS)
研究概览
简要总结
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.
详细描述
The present study aims to analyze the effects of focal muscle vibration in patients with sABI. This study is innovative for the setting, as it will take place for the first time within a neurorehabilitation hospital ward, for the intensity of the treatment as patients will undergo daily treatment sessions, for longer periods than protocols so far in the scientific literature. Finally, the cortical effects of the vibratory stimulus will be analyzed through the analysis of cortical neurophysiological correlates
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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+
排除标准
- •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.
研究组 & 干预措施
G-FMV (Group Focal Muscular Vibration)
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.
干预措施: Focal Muscular Vibration using the EVM EVO medical device (Endomedica, Italy) (Device)
G-CON (Group Conventional)
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...)
干预措施: Conventional Rehabilitation (Other)
结局指标
主要结局
Reduction of spasticity, assessed by Modified Ashworth Scale (MAS)
时间窗: Change from Baseline MAS at 3 weeks and at 6 weeks
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.
次要结局
- 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)
- 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 Pain Assessment IN Advanced Dementia (Painad)(Change from Baseline Painad at 3 weeks and at 6 weeks)
- Reduction of disability, assessed by Disability Rating Scale (DRS)(Change from Baseline DRS 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)
- Changes in electrocortical activity, assessed by electroencephalogram (EEG)(Change from Baseline EEG at 3 weeks and at 6 weeks)
- Changes in muscle activation, assessed by electromyography (EMG)(Change from Baseline EMG at 3 weeks and at 6 weeks)
研究者
PADUA LUCA
Associated Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS