Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke, Experimental Study in Single Cases.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Fluidity of the upper limb
研究概览
简要总结
Recent work on large cohorts of chronic stroke (>6 months post-stroke) have shown that intensive training of the upper limb in the chronic stroke patients can lead to substantial motor and functional gains that are maintained at 6 months post intervention.
A very prolonged (12 weeks) and very intensive (5 hours daily) training applied to chronic patients after stroke brings a substantial gain both motor and functional which is maintained at 3 months post intervention.
Robotic rehabilitation have been shown to be as effective as any other treatment used in rehabilitation. But the methods of implementation remain widely debated. At that time, most robotic therapies have tried to reproduce functional movement mainly pointing objects.
We want to demonstrate that analytic movements of the elbow and the shoulder performed with the Luna-EMG robot can replace part of usual physiotherapy treatment with at least the same effectiveness on the recovery of fluid movements of the upper limb after a stroke.
详细描述
This is a pilot study following a single case experimental design with multiple baselines across subjects (MBD).
People included in the protocol will benefit from 2 hours of daily treatment during 6 to 7.5 weeks. The first 2 weeks will be dedicated to baseline measurement of their upper limb (UL) status with daily treatment for balance and gait control without any treatment of the upper limb. The rest of the time will be dedicated to upper limb treatment exclusively. It will be divided into 2 UL training periods, one of them including a 30mn treatment with the luna EMG robot. The duration of second period will be randomly defined between 2 to 3.5 weeks and the last period will last 2 weeks. The treatment during the first UL treatment period will be randomly allocated to Luna EMG treatment or not. The next period will thus follow the inverse scheme (without if the first contains Luna EMG treatment). The fluidity will be assessed through pointing movements assessed every two days. Evaluation of motor deficiency (Fugl Meyer) and functional status (ARAT score) of the UL will be weekly assessed after the inclusion visit. 3D motion analysis of the UL will also be weekly performed.
All patients will benefit from a regular follow-up and from an organized care protocol. The sessions will be intensive, all subjects will be able to benefit from the new treatment (LUNA EMG). We can expect a direct individual benefit from the proposed intensive treatment, at least for precision of UL movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will not know what phase the patient is in at the time of assessment or what experimental design the patient was randomized to.
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 >= 18 years
- •Hemiparesis after a first stroke with more than 1 year time interval
- •Functional upper limb: ability to do a pointing task at 90% of the hand-acromion distance (free trunk).
- •Spastic hypertonia of the elbow flexors 0-2/4 on the Modified Ashworth scale
- •Patient affiliated with social security
- •Patient having signed a consent to participate in the research
排除标准
- •Inability to sign written consent
- •Flexed elbow > 30° during passive mobilization of the upper limb
- •EVA>3 in the upper limb at rest or during mobilization
- •Complete loss of upper limb proprioception
- •Neuro-orthopedic surgery of the upper limb for spasticity: neurotomy, tenotomy, transfer
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Experimental Scheme : A,B,C
The phase B treatment (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot) is scheduled before phase C (2 hours a day, 5/7 days of conventional rehabilitation). The duration of phase B is randomized between 6 and 11 evaluations (2 to 3.5 weeks).
干预措施: LUNA-EMG Robot (Device)
Experimental Scheme : A,C,B
The phase C treatment (2 hours a day, 5/7 days of conventional rehabilitation) is scheduled before phase B (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot). The duration of phase C is randomized between 6 and 11 evaluations (2 to 3.5 weeks).
干预措施: LUNA-EMG Robot (Device)
结局指标
主要结局
Fluidity of the upper limb
时间窗: up to 7.5weeks
Repeated evaluation of hand movement by the SPARC index during five pointing tasks at 90% of the length of the upper limb at clavicle height, at comfortable speed.
次要结局
- Straightness of movement(up to 7.5weeks)
- Pain assessment(up to 7.5weeks)
- Function assessment(up to 7.5weeks)
- Average speed of movement(up to 7.5weeks)
- Motricity assessment(up to 7.5weeks)
- Duration of movement(up to 7.5weeks)
- Acceptability of the use of the robot(up to 7.5weeks)
- Satisfaction of the use of the robot(up to 7.5weeks)
- Spasticity(up to 7.5weeks)