A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 12
- 主要终点
- Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA
研究概览
简要总结
Loss of arm function is a common and distressing consequence of stroke. Neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. This multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.
详细描述
Stroke is the most common cause of complex adult disability in high-income countries [1]. Loss of arm function affects 69% of people who have a stroke [2]. Only 12% of people with arm weakness at the onset of stroke make a full recovery [3]. Improving arm function has been identified as a research priority by stroke survivors, carers, and health professionals who report that current rehabilitation pays insufficient attention to arm recovery [4].
Robot-assisted training enables a greater number of repetitive tasks to be practiced in a consistent and controllable manner. Repetitive task training is known to drive Hebbian plasticity, where the wiring of pathways that are coincidently active is strengthened [5, 6]. A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke [7] and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke. We anticipate that Hebbian neuroplasticity, which is learning dependent, will operate regardless of the post-stroke phase. We, hereby, describe the protocol for a multicentre randomized controlled trial to determine whether robot-assisted training improves upper limb function following a stroke in the sub-acute stage.
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)
盲法说明
The outcome assessor will be blind to the study protocol.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* age between 18 and 85 years;
- •* first stroke with neurological outcomes affecting the upper limb;
- •* patients with severe or moderate hemiparesis (FM-UL≤44), stratified according to severe (FM-UL ≤ 22) or moderate (22 \ 30);
- •* Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb \<3;
- •* sufficient cognitive and linguistic level to understand the instructions and provide consent;
- •* signed informed consent.
排除标准
- •unstable general clinical conditions;
- •severe visual impairment;
- •inability to maintain the sitting position;
- •mild motor deficit of the arm (FM-UL> 44) at baseline;
- •recent botox injection in the upper limb or planned botox injection during the study period, including the follow-up;
- •inability to don the orthosis on the impaired upper limb;
- •bone instability in relevant areas of the upper extremity (unconsolidated fractures, fractures due to osteoporosis);
- •fixed contractures involving the impaired upper limb (e.g. frozen shoulder);
- •shoulder instability;
- •severe pain syndromes caused or intensified by rehabilitation with Armeo Power;
- •patients who need isolation for infectious diseases ;
- •epileptic disorder with frequent attacks that carry the risk of having a seizure during rehabilitation with Armeo Power;
- •history of physical or neurological conditions that interfere with study procedures or assessment of motor function;
- •interruption of treatment for 1 week, or 5 consecutive sessions;
- •participation in other innovative treatment protocols for the upper limb rehabilitation (e.g. robotics, virtual reality, AOT ... etc).
结局指标
主要结局
Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA
时间窗: Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. In this study, we will consider the motor performance items of Upper extremity (0-66), only.
次要结局
- Change in Nine Hole Peg Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Modified Ashworth Scale (shoulder, elbow, and wrist).(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Box & Block Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Frenchy Arm Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in modified Barthel Index(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Modified Rankin scale(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Modified Ashworth Scale (shoulder, elbow, and wrist).(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Box & Block Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Nine Hole Peg Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Frenchy Arm Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in modified Barthel Index(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Modified Rankin scale(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)