Can Upper Limb Robotic Rehabilitation Plus Muscle Vibration Improve Motor Function? A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Assessment of spasticity-MAS
研究概览
简要总结
Muscle vibration (MV) has been suggested as a useful non-pharmacological approach to control spasticity. Armeo Power® (AP) is a robotic exoskeleton for rehabilitation allowing early rehabilitation treatment. The objective of our study was to determine whether AP training coupled with MV applied on antagonist muscles of the spastic upper limb (UL) can reduce the spasticity of agonist muscles. We enrolled 20 chronic post-stroke patients, who underwent 40 daily sessions of AP training. Ten subjects (group-A) received muscle MV (on triceps brachii, deltoid, and supraspinatus), whereas the other 10 (group-B) underwent a sham vibration.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a first ever supra-tentorial unilateral (left hemisphere) ischemic stroke experienced more than three months before the enrollment;
- •a deficit of shoulder abductor, arm flexor, and elbow extensor muscles ranging from 2 to 4 on the Medical Research Council scale (MRC);
- •a spasticity of biceps brachii (BB), pectoralis major (PM), and latissimus dorsi (LD) (namely, spastic agonist muscles) ranging from 1+ to 3 on the Modified Ashworth Scale (MAS);
- •age between 50 and 80 years; and (v) Caucasian ethnicity.
排除标准
- •history of concomitant neurodegenerative diseases or brain surgery;
- •severe cognitive (Mini-Mental State Examination score <23 points) or language impairment (Boston Disability Aphasia Quotient <4/5);
- •severe neglect (Catherine Bergego Scale >15/30);
- •systemic, bone, or joint disorders, tumors, changes in either central or peripheral sensitivity as well as visual impairments able to interfere with the aims and methods of the research;.(v) concomitant use of drugs for spasticity;
- •botulin toxin treatment in the last eight months;.(vii) TMS contraindications;
- •history of psychosis;
- •limited passive range of motion (shoulder abduction <60°, elbow extension <30°, specified by a goniometric assessment).
结局指标
主要结局
Assessment of spasticity-MAS
时间窗: Six months
The primary outcomes consisted in the effects of MV and Armeo Power® on spasticity by a clinical (MAS from spastic agonist muscles causing arm adduction, inward rotation, and flexion, and forearm flexion)
次要结局
- Fugl-Meyer Assessment of UL motor recovery after stroke -FMA(Six months)
研究者
Rocco Salvatore Calabrò
Principal investigator
IRCCS Centro Neurolesi "Bonino-Pulejo"