Combined Robot-assisted Upper Limb Training and Botulinum Toxin Treatment for Upper Limb Function and Spasticity: a Randomized Controlled Single-blinded Trial in 32 Chronic Stroke Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Fugl Meyer Upper Limb Assessment scale
研究概览
简要总结
To date, evidence of the effects of robotic training combined with OnabotulinumtoxinA focal treatment for spasticity is limited. The objective of this study were to compare the effects of robotic training against conventional rehabilitation on functional recovery, strength and spasticity, in stroke patients who underwent OnabotulinumtoxinA focal treatment for spasticity. We performed a single-blind, randomized, controlled trial involving 24 outpatients with diagnoses of stroke, divided in two groups (experimental and control group). Experimental group received specific robotic training for the upper limb with the device Armotion/Motore (Reha Technology AG, Olten, Switzerland). Our primary outcome was Fugl-Meyer Assessment Motor Scale (FMA). Secondary outcome were Action Research Arm Test (ARAT), Modified Ashworth Scale (MAS), Medical Research Council Scale (MRC) and surface Electromyography (EMG). 14 healthy age-matched controls underwent one session of sEMG acquisition to collect normative data.
详细描述
This single-blind RCT with two parallel group was conducted according to the tenets of the Declaration of Helsinki, the guidelines for Good Clinical practice, and the Consolidated Standards of Reporting Trials (CONSORT).
Target population was chronic post-stroke patients who attend to the Neurorehabilitation Unit (AOUI Verona) where they were assessed for eligibility.
Who satisfied inclusion and exclusion criteria were randomly allocated in one of two groups, experimental group ad control group. Each patient, underwent BoNT injection in the paretic limb. The dose of BoNT injected into the target muscle was based on the severity of spasticity in each case. Different commercial formulations of BoNT were used according to the pharmaceutical portfolio contracts of our Hospital (Onabotulinumtoxin A, Abobotulinumtoxin A and Incobotulinumtoxin A). The dose, volume and number of injection sites were set accordingly. A Logiq ® Book XP portable ultrasound system (GE Healthcare; Chalfont St. Giles, UK) was used to inject BoNT into the target muscle.
Prior of the start of the study authors designed the experimental and the control group protocols. Two physiotherapists, one for each group carried out the rehabilitation procedures. Patients of both groups received 10 individual sessions (45 min/session, 2 sessions/week, five consecutive weeks). Treatments were performed in the rehabilitative gym of the G.B. Rossi University Hospital Neurological Rehabilitation Unit.
A subgroup of patients in the experimental group were investigated by Electromyography during the "hand-to-mouth" motor task (ARAT sub-item). The subject seated in a comfortable position on a chair with backrest, the feet resting on the floor and the knees and hips flexed at 90°. The start position consisted of the hand of the examined side lying on the distal third of the thigh. Then, the patient was asked to touch his mouth with the palm of the hand at normal speed and return to the starting position. The patient was instructed not move the head toward the hand. No other indications regarding how to move the arm for not to influence the spontaneity of the movement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years;
- •diagnosis of ischemic or hemorrhagic first-ever stroke as documented by a computerized tomography scan or magnetic resonance imaging;
- •at least 6 months since stroke;
- •Modified Ashworth Scale (MAS) score (shoulder and elbow) ≤ 3 and ≥1+;
- •BoNT injection within the previous 12 weeks of at least one of muscles of the affected upper limb;
- •Mini-Mental State Examination (MMSE) score ≥24
- •Trunk Control Test score = 100/100.
排除标准
- •any type of rehabilitation intervention in the 3 months prior to recruitment;
- •bilateral cerebrovascular lesion;
- •severe neuropsychologic impairment (global aphasia, severe attention deficit or neglect);
- •concomitant orthopedic disorders.
研究组 & 干预措施
Experimental group
The experimental group was treated using a robot assisted arm training, Armotion (Reha Technology, Olten, Switzerland).
干预措施: Experimental group - robot assisted arm training (Armotion®) (Device)
Control group
The control group was treated using a conventional training, without end effector robot.
干预措施: Control group - conventional treatment (Other)
结局指标
主要结局
Fugl Meyer Upper Limb Assessment scale
时间窗: Up to six weeks
Evaluate functional improvements of upper limbs
次要结局
- Modified Ashworth Scale(Up to six weeks)
- Medical Research Council Scale(Up to six weeks)
- UL electromyographic analysis of muscle activation(Up to six weeks)
- Active Range of Motion(Up to six weeks)
研究者
Nicola Smania, MD, Clinical Professor
MD
Universita di Verona