Clinical Use of Andante SmartStep System in Gait Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- load bearing over the affected lower limb
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.
详细描述
To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Rehabilitation after operation
- •Patient is allowed full weight bearing
- •Patient is motivated and able to communicate and understands orders
- •Patient is able to walk 10 meters
- •Patient filled out agreement and consent form
排除标准
- •Activity limitation due to medical disorder, medications, or emotional status.
- •Pain markedly obstructs gait ability
- •Documented peripheral neuropathy
- •Functional limitation prior to the current condition
- •Premorbid, ongoing major depression or psychosis
- •Multiple/pathological fractures
- •Serious early complications
- •Terminally ill patients
- •Pregnant women
- •Participation in current or recent (within 60 days prior to surgery) clinical trial
结局指标
主要结局
load bearing over the affected lower limb
quality/symmetry of gait
level of ambulation and physical independence
次要结局
未报告次要终点