Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in ARAT score
研究概览
简要总结
The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area.
- •Inclusion Criteria:
- •Providing written informed consent prior to any study related procedures;
- •Age between 18-75 years;
- •Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
- •Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
- •No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
- •Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
- •No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
排除标准
- •Subjects will be excluded if they have:
- •Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- •Subject who cannot provide self-transportation to the study location.
研究组 & 干预措施
Assist-As-Needed Control
Subjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an "adaptive mode". In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an "assist-as-needed" protocol.
Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion.
干预措施: MAHI Exo-II (Device)
Subject-Triggered Control
Subjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system. In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e. elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension). The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall.
干预措施: MAHI Exo-II (Device)
结局指标
主要结局
Change in ARAT score
时间窗: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
次要结局
- Change in smoothness metrics(Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start)
- Change in Modified Ashworth Scale(Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program)
- Change in Grip Pinch Strength Assessment(Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program)
- Change in Graded Redefined Assessment of Strength, Sensibility and Prehension(Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program)
- Change in Smoothness metrics(Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program)