Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by MuscLe Synergy-derived ELectrical StimulatiOn in Post-stroke Patients (OTHELLO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in measure of upper extremity motor performance as assessed using the Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Extremity (FMA-UE) score.
研究概览
简要总结
Stroke is the third most common cause of disability worldwide and leads to upper limb motor disease in more than half of people affected.
Recent data demonstrate that upper limb rehabilitation can be pursued using techniques such as the observation of action (Action Observation Therapy - AOT) or the stimulation of limb musculature using surface electrodes (Neuromuscular Electrical Stimulation - NMES).
To date, no rehabilitation studies used both the treatments (AOT-NMES) for the rehabilitation of upper limb after stroke.
The goal of this clinical trial is to study the efficacy of this combined approach (AOT-NMES) in people who developed upper limb motor impairment after stroke.
The main question this study aims to answer is if the rehabilitation performed using both action observation and neuromuscular stimulation has an higher efficacy than the use of AOT alone and higher than the observation of non-motor stimuli.
Participants will be people with upper limb impairment after stroke and will perform 15 rehabilitation sessions (5/week, 3 weeks, 60 minutes each).
Each participant will be casually included in one of following three rehabilitation groups:
- Action observation associated with neuromuscular stimulation (AOT-NMES, experimental condition): they will observe upper limb movements while their arm muscles will be stimulated. After the observation phase they will try to perform the same movements with the impaired arm.
- Action observation alone (AOT): subjects will observe upper limb movements and after the observation phase then they will try to execute them with the impaired arm.
- Motor-neutral observation (MNO): subjects will observe non-movement videos and after the observation phase they will try to execute upper limb movements with the impaired arm.
Each participant will be evaluated for motor function before and after rehabilitation treatment and researchers will compare the motion improvement between the groups to assess the efficacy of AOT-NMES over other treatments.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years;
- •Upper arm motor impairment after unilateral stroke as verified by MRI or CT;
- •Two weeks up to 6 months after stroke;
- •Grading of upper arm motor impairment>2 at Medical Research Council scale (MRC).
排除标准
- •Neurological/orthopedic issues that would interfere with upper limb exercises;
- •Presence of any medical condition that represents a contraindication to Magnetic Resonance Imaging (MRI) examination or to Transcranial Magnetic Stimulation (TMS);
- •Presence of dermatologic issues that will interfere with neuromuscular stimulator;
- •Presence of electronic subcutaneous implants;
- •Presence of peripheral neuropathy;
- •Epilepsy;
- •Pregnancy;
- •Presence of severe cognitive impairment, including language comprehension detected during the neurological evaluation.
结局指标
主要结局
Changes in measure of upper extremity motor performance as assessed using the Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Extremity (FMA-UE) score.
时间窗: Baseline, 1 month (End of treatment), 6 months (Follow-up)
The Fugl-Meyer Assessment of Motor Recovery after Stroke is one of the most widely used measures of motor impairment in post-stroke hemiplegic patients, covering 5 domains (Motor function, sensory function, balance, joint range of motion, joint pain). The assessment of upper extremity motion is performed using the Upper Extremity assessment (FMA-UE), including items scored on a 3-point ordinal scale (0: cannot perform, 1: performs partially; 2: performs fully) with total maximum score: 66 points (higher scores, best clinical profile).
次要结局
- Changes in quality of life as self-rated in the EuroQol five dimensions (5D) and five levels (5L) questionnaire (EQ-5D-5L)(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in muscular electrical activity during motor acts as measured using surface Electromyography (EMGs).(Baseline, 1 month (End of treatment))
- Changes in the corticospinal excitability, assessed using Motor Evoked Potentials (MEPs).(Baseline, 1 month (End of treatment))
- Changes in muscular synergies(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in brain sensory-motor networks, as investigated using functional Magnetic Resonance Imaging (fMRI).(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in global cognitive functioning as assessed using the Montreal COgnitive Assessment (MoCA) score.(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in microstructural brain properties, assessed using advanced Magnetic Resonance Imaging (MRI) techniques.(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in measure of upper limb functioning as assessed using the Action Research Arm test (ARAT)(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in health and disability status as measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in Stroke-associated quality of life as assessed using specific subscores of the Stroke Impact Scale (SIS) 3.0(Baseline, 1 month (End of treatment), 6 months (Follow-up))
- Changes in motoneuron reflex excitability measured as H/M ratio amplitude.(Baseline, 1 month (End of treatment))
- Changes in movement parameters extracted from body kinematics.(Baseline, 1 month (End of treatment), 6 months (Follow-up))