A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Six-minute walk test
研究概览
简要总结
Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. In order to evaluate the safety and efficacy of the Smart Power Armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.
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
- 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
- •Age 18-70 years old;
- •Spinal surgery within 1 year due to degeneration, tumor, trauma or other reasons, postoperative motor disorders of both lower limbs, such as muscle weakness (3-5 level reduction), increased muscle tone, gait incoordination caused by deep sensory loss, etc.;
- •The patient does not have a plan to rehabilitate in a specialized rehabilitation hospital, and plans to rehabilitate at home;
排除标准
- •Short expected survival from malignant diseases;
- •Muscle strength is less than grade 3, and the muscles of both lower limbs are severely atrophied;
- •Suffering from other neurological diseases;
- •Planned to undergo other surgeries within 3 months;
- •Unable to cooperate with the transmission power external armor or cooperate with the rehabilitation training due to the physical condition;
结局指标
主要结局
Six-minute walk test
时间窗: 3 months
meter; distance participants walked as fast as possible in a flat corridor in six minutes
次要结局
- Thigh Lifting Moment(3 months)
- 10 meter autonomous walking test(3 months)
- 10 meter fast walking test(3 months)
- Average rate of change in muscle strength(3 months)
- rate of change in hip joint mobility(3 months)
- stride length(3 months)
- adverse event incidence rate(12 months)
- Thigh Swing Angle(3 months)
- rate of change in heart rate(3 months)
- rate of change in arterial partial pressure of oxygen(3 months)
- serious adverse event incidence rate(12 months)
- Thigh Swing Speed(3 months)