Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Change in gait speed
研究概览
简要总结
The purpose of this study is to know the effectiveness of different robotic devices for gait rehabilitation in stroke patients
详细描述
Subjects will attend the Neuron rehabilitation clinic on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent the patient will be assessed with the Timed Up and Go Test and 10 Meter Walking Test, and it will be realized a spatio temporal variables analysis with baiobit system and a superficial Electomiografic activity analysis during gait with Noraxon system.
Once the assessment is completed, the participant will receive the treatment assigned at his rehabilitation clinic. The patient will receive 30 minutes of robotic treatment with Lexi, Lokomat, C-Mill or the body-weight support treadmill and 15 minutes of overground walking training between 70-85% of HR max.
Once the treatment period is over, after 25 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution at the start of the study
- •Presenting gait deficits compatible with a level between 2 and 3 of the functional category of gait (FAC)
- •More than 20 seconds in the Time Up and Go test
- •Less than 3 points on the Reisberg Global Deterioration Scale (GDS-R).
排除标准
- •Presenting any type of specific contraindication to use the robotic device to be used with respect to their group. Thus, those patients who present a limitation in the range of movement in the hip of more than 0º of extension and 40º of flexion, in the knee of less than 30º of flexion and in the ankle of less than 0º of dorsal flexion will not be able to participate in the study.
- •Lower limb spasticity greater than 3 on the modified Asworth scale
- •Unable to maintain an assisted standing position for more than 5 minutes
- •Unable to understand simple commands
结局指标
主要结局
Change in gait speed
时间窗: Change from Baseline in gait speed at 4 weeks
The velocity at which the patient is able to cover 6 meters at comfortable speed. It will be measured with the 10 Meter walking test in which the evaluator tells the patient to walk over 10 meters and takes the time required to cover the 6 meters in the middle, leaving the 2 initial and final meter for acceleration and deceleration.
次要结局
- Gait ratio(Change from Baseline in gait ratio at 4 weeks)
- Change in risk of falling(Change from Baseline in risk of falling at 4 weeks)
- Changue in balance(Change from Baseline in balance at 4 weeks)
- Double stance time during the gait cycle(Change from Baseline in double stance time during the gait cycle at 4 weeks)
- Percentage of time in stance phase during the gait cycle(Change from Baseline in percentage of time in stance phase during the gait cycle at 4 weeks)
- Maximal Voluntary Contraction (MVC) of the rectus femurs(Change from Baseline in MVC of the rectus femurs at 4 weeks)
- Co-contraction index(Change from Baseline in co-contraction index at 4 weeks)
研究者
Alfredo Lerín Calvo
Coordinator in Research Department
Neuron, Spain