Robotic Assessment of Lower Extremity Motor Learning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Step Length Adaptation
研究概览
简要总结
The aim of the study is to assess the ability of healthy subjects to generate a motor adaptation in response to a mechanical perturbation generated by a robotic system for treadmill-based gait training (Lokomat by Hocoma AG, a device that received 510K FDA clearance).
详细描述
The study is divided into two phases.
In phase I of the study, we intend to assess the response of individuals to a variety of different mechanical perturbations generated by a robotic system for treadmill-based gait training (Lokomat by Hocoma AG). Such response is quantified as a displacement from the baseline (i.e. gait cycles with no mechanical perturbation) trajectory of motion of the foot during the swing phase of the gait cycle. This portion of the study is expected to allow us to identify mechanical perturbations that are suitable to study motor adaptation.
In phase II of the study, we plan to carry out experiments using the above-mentioned robotic system to assess the magnitude of the motor adaptation to the mechanical perturbations identified in phase I as suitable for the study. The magnitude of the motor adaptation is quantified as the percentage of the deviation from the baseline trajectory of motion of the foot that subjects compensate for when exposed to the perturbation during multiple consecutive gait cycles.
It is worth noticing that the robotic system utilized to generate the mechanical perturbations (i.e. Lokomat by Hocoma AG) is not programmed by the company to generate the mechanical perturbations evaluated in this project. Our research group wrote the programs to generate such perturbations. It is also worth emphasizing that the 510K FDA clearance does not cover the modifications implemented by our research group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, healthy adults age 18-55 years, with normal gait.
排除标准
- •Lower extremity fractures
- •Current or previous history of orthopedic injury that would prevent safe use of the robotic system
- •Body/femoral length size beyond the limits of robotic system (femur length between 350-470mm)
- •Body weight > 135kg (~298 lbs) maximum limit of the body weight support system
- •Skin lesions on the lower extremities
- •Cardiovascular or pulmonary contraindications
- •Motor system or proprioceptive impairments
- •Severe cognitive impairments that would prevent the use of the robotic system
结局指标
主要结局
Step Length Adaptation
时间窗: within a trial of the experiment (i.e. a few minutes)
The percentage of the step length change caused by the mechanical perturbation that subjects compensate for
次要结局
- Step Height Adaptation(within a trial of the experiment (i.e. a few minutes))
研究者
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital
