Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in postural stability during walking
研究概览
简要总结
Rehabilitation robotics is increasingly used because it enables the patients to practice a wide array of movements. Dynamic balance training is essential for gait rehabilitation and robotised devices enhance repeatability, objectivity and precision of such training combined with monitoring and recording of kinematic and kinetic data. The aim of the study is to explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off in patients after stroke. The investigators will conduct a randomised intervention study where one group will receive visual feedback on gait status and the other group will receive kinetically-assisted training using a robotised device in addition to the visual feedback.
详细描述
Gait training will start 3 weeks after admission to inpatient rehabilitation. It will last for 3 weeks, 5 times per week, 30 minutes per day. The first few sessions with the robotic device will serve to familiarise the patient with the BART device and training conditions. Further details are described in the Arms and Interventions section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Subacute phase after first ischaemic or haemorrhagic stroke (less than 6 months after stroke);
- •Limb hemiparesis;
- •Ability to walk independently (FAC 6) or with assistance (FAC 5) on flat and uneven surfaces, stairs and slopes;
- •Adequate cardiovascular ability (NYHA 1).
排除标准
- •Degenerative process or postoperative condition on lower-limb joints that would hinder gait;
- •Associated neurological disease;
- •Decreased cognitive ability (KPSS < 25).
研究组 & 干预措施
Controls
In each session, the group will undergo standard gait training on BART without pelvic perturbations, i.e.,
- walk a virtual track on the BART without pelvic perturbations (i.e., the pelvic brace of the BART device will be set to follow the patient's motion) for 10 minutes;
- practise gait symmetry and take-off using visual feedback without pelvic perturbations in two 10-minute sessions.
干预措施: Standard gait training on BART without pelvic perturbations (Device)
Experimental
In each session, the group will undergo robotised gait training with BART with pelvic perturbations, i.e.,
- walk a virtual track on the BART with pelvic perturbations during virtual uphill walk and virtual curved walk for 10 minutes;
- practise gait symmetry and take-off using visual feedback with pelvic perturbations for 10 minutes;
- practise dynamic gait balance using pelvic perturbations during treadmill walking for 10 minutes.
干预措施: Robotised gait training with BART with pelvic perturbations (Device)
结局指标
主要结局
Change in postural stability during walking
时间窗: Assessment before and after the 3-week training programme
Assessed using the Functional Gait Assessment (FGA) scale. The scale scores range from 0 to 30, with higher scores indicating less impairment.
次要结局
- Change in functional ambulation category(Assessment before and after the 3-week training programme)
- Change in fall-risk related mobility(Assessment before and after the 3-week training programme)
- Change in functional independence(Assessment before and after the 3-week training programme)
- Change in ability to change directions while stepping(Assessment before and after the 3-week training programme)
- Change in walking speed over a short distance(Assessment before and after the 3-week training programme)
- Change in walking speed over a long distance(Assessment before and after the 3-week training programme)