Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Gait Deviation Index without assistance
研究概览
简要总结
This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
详细描述
This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis.
The device is composed by a passive orthosis structure which allows one degree of freedom (DOF) among the sagittal plane and it includes two servomotors attached to the user's foot through velcro strips.
Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiparesis caused by a stroke.
- •Age between 18 and 65 years old.
- •Post-stroke time more than 6 months.
- •Independent walking.
- •Minimum 90 degrees of dorsiflexion.
- •Muscle tone in plantar flexors less than of equal to 3 on the Modified Ashworth scale.
- •Ability to follow instructions.
- •Voluntary participation.
排除标准
- •Skin alterations in the lower limb.
- •Peripherical vascular alterations.
- •Alterations in sensitivity in the lower limb.
- •Pain of musculoskeletal origin in lower extremities or spine.
- •History of frequent falls.
- •Previous history or suspected seizures.
- •Patient who does not sign the informed consent.
结局指标
主要结局
Gait Deviation Index without assistance
时间窗: Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index assisted by motorized ankle foot orthosis
时间窗: Day 1
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
时间窗: Day 1
Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction
次要结局
未报告次要终点