Effects of a Lower Limb Strength Training Program on a Seated Robotic Device in Subacute Acquired Brain Injury Patients: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- change from study inclusion to end of intervention at 5 weeks in strength of knee extensor's
研究概览
简要总结
The loss of lower limb strength that occurs after an Acquired Brain Injury (ABI) limits the patient's autonomy in participating in activities of daily living, including gait performance. In the sub-acute phase, it is difficult to implement a strengthening program, as weakness prevents exercise being performed with the recommended parameters. This limit can be exceeded by using specific robotic devices, which allow the effort provided to be adapted according to the patient's capacities. In addition, motivation can be improved by the use of feedback or incentive games. The aim of this pilot study is to obtain data on the effect of lower limb strength training with a seated robotic device in subacute ABI patients for a future larger randomised study. In addition, it aims to evaluate the recruitment rate, applicability, resources for implementation and patient tolerance to the training program.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acquired Brain Injury of vascular, traumatic, infectious or tumoral origin in the subacute phase
- •Walking ability ≤ Functional Ambulatory Category level 5 (1-6)
- •Paresis of the lower limb: strength <57/100 on the Motricity Index
- •Cognitive and memory functions allowing the patient to follow treatment instructions and give informed consent
排除标准
- •Significant heart problem
- •Venous thrombosis less than 6 months
- •Musculoskeletal impairment not compatible with movement
- •Degenerative neurological disease
- •Oxygen-dependent
- •Blood pressure not stabilized
结局指标
主要结局
change from study inclusion to end of intervention at 5 weeks in strength of knee extensor's
时间窗: Study inclusion to end of intervention at 5 weeks
measure with a manuel dynamometer, in newton
次要结局
- change from study inclusion to end of intervention at 5 weeks in Ashworth Scale (spasticity)(Study inclusion to end of intervention at 5 weeks)
- change from study inclusion to end of intervention at 5 weeks in Motricity index legs(Study inclusion to end of intervention at 5 weeks)
- change from study inclusion to end of intervention at 5 weeks in timed up and go(Study inclusion to end of intervention at 5 weeks)
- change from study inclusion to end of intervention at 5 weeks in 10 meters walk test(Study inclusion to end of intervention at 5 weeks)