Development and Validation of an Instrumented Ankle-foot Orthosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Heel strike angle
研究概览
简要总结
Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.
TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Patients questionnaire:
- •Having foot drop
- •Inclusion Criteria for Clinician questionnaire:
- •Being a clinician who treats foot drop patients
- •Inclusion Criteria for Gait analysis:
- •Having foot drop
排除标准
- •for Gait analysis:
- •Not being able to walk without a cane or a walker
- •Having lower extremity spasticity
结局指标
主要结局
Heel strike angle
时间窗: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Heel strike angle measured by the instrumented orthosis and the reference system
Gait Temporal parameters
时间窗: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).
Gait Spatial parameters
时间窗: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.
Gait speed
时间窗: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Gait speed measured by the instrumented orthosis and the reference system, in meters per second.
次要结局
未报告次要终点