NCT05176600Unknown不适用
Pilot Study on the Evaluation of the Functionality, Safety and Feasibility of a Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke
Wearable Robotics srl.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of adverse events and description
研究概览
简要总结
The purpose of the study is to test the technical functionality, safety, and feasibility of a bimanual robotic exoskeletal platform and associated serious games in order to offer information on technological and functional advances that will be included in the device's finalization.
In addition, a secondary goal will be to assess the therapeutic effects of a rehabilitation therapy based on the bimanual configuration, comparing it to a unimanual treatment delivered on the same platform (using the specific configuration).
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)
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
- •height between 150 and 190 cm;
- •weight not exceeding 130 kg;
- •ischemic injury;
- •first cortical and supra-tentorial event;
- •moderate motor deficit of the upper limb (score on the Fugl-Meyer Assessment - Upper Extremity between 29 and 42);
- •time since stroke event between 1 and 6 months;
- •trunk control test score greater than or equal to 48;
- •healthy bone density and skeleton that does not suffer from unhealed fractures.
排除标准
- •Relevant medical comorbidities (severe neurological diseases, cardiovascular diseases, diabetes / unstabilized hypertension);
- •Cognitive impairment that prevents understanding of the exercises administered;
- •Unavailability to provide informed consent;
- •Pregnant women;
- •Severe spasticity (Ashworth 4);
- •Major muscle contractures;
- •Excessive asymmetry in the length of the arms;
- •Upper limb prostheses;
- •Excessive joint limitations that make it difficult or painful to use the device;
- •Use of pacemakers or implantation of active devices;
- •Patients who already participate in another clinical study or who are already undergoing another similar robotic rehabilitation treatment.
结局指标
主要结局
Incidence of adverse events and description
时间窗: through the study, an average of 10 months
Number and description of adverse events related to the provided intervention
次要结局
- Changes in EEG-based Connectivity index(Before the intervention, 1 week after the end of the 30-session robotic intervention)
- Changes in EEG-based Interhemispheric coupling index(Before the intervention, 1 week after the end of the 30-session robotic intervention)
- Changes in Fugl-meyer Assessment Upper Extremity motor functioning(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Wolf Motor Function Test(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Fugl-meyer Assessment - Sensory functioning(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Modified Ashworth Scale(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Motricity Index for upper extremity(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Action Research Arm Test (ARAT)(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Execution time (seconds) measured with the robot(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Range of Motion (degrees) measured with the robot(Before the intervention, after a 6-week robotic rehabilitation intervention)
- Changes in Number of velocity peaks measured with the robot(Before the intervention, after a 6-week robotic rehabilitation intervention)
- System Usability Scale(After a 6-week robotic rehabilitation intervention)
- Technology Acceptance Model (TAM)(After a 6-week robotic rehabilitation intervention)
- Likert for Satisfaction(After a 6-week robotic rehabilitation intervention)
研究者
Lucia Lencioni
CEO
Wearable Robotics srl.
研究点 (2)
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