The Effect of Robot-assisted Gait Training on Cardiovascular Health and Activity Levels Within Early-subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pulse wave velocity (carotid-femoral)
研究概览
简要总结
A stroke happens when blood flow to the brain is cut off. Many people struggle to walk after having a stroke. Regaining the ability to walk is a key aim for many stroke survivors and rehabilitation practitioners as it allows improved independence and better health. This study will assess a rehabilitation method called robot-assisted gait training (RAGT) with stroke patients. RAGT uses a robotic device to assist the patient in taking steps. The RAGT device being investigated in this study is called the Lokomat. This device uses a treadmill, a harness, and a robotic suit to help the user to take steps. In particular, the study will aim to determine whether this form of training can improve the health of the heart and blood vessels (cardiovascular health) of people with stroke. Also, the study will assess whether RAGT helps stroke patients to be more physically active in the initial stages after they have a stroke. Physical activity and cardiovascular health are linked. Physical inactivity, and increased sedentary behaviours, which are both common post-stroke, can lead to worsening cardiovascular health, and increase the risk of another stroke, hence why these are both principal research questions of the study.
Patients at one of two NHS inpatient stroke units will be invited to participate in the research - one which uses the Lokomat as standard care and one which does not. The decision to participate (or not) will not result in a change in their care plan, but if they do decide to participate, the research team will collect some additional data to help answer the questions this study is attempting to answer. All the measurements taken will be safe, non-intrusive and pain free. The results of patients using the Lokomat at one stroke unit will be compared to patients in the other inpatient stroke unit not using the device.
The investigators expect to see that participants who complete RAGT are more physically active both during and after the RAGT they receive.
详细描述
The design of the study
This study will be a retrospective-matched non-randomised trial. The physical activity and cardiovascular health of stroke patients using the Lokomat at an inpatient stroke unit (Royal Bournemouth Hospital) will be monitored over time. The same measurements will be conducted with another set of patients at another stroke unit (Royal Hampshire County Hospital) who do not receive any form of RAGT. These patients will be matched retrospectively with those who used the Lokomat at the first study site, and then the results of the two sets of patients will be compared. Both sets of patients will satisfy the inclusion and exclusion criteria. Matching of participants will be based upon baseline Functional Ambulation Category (FAC) score; blood pressure, and age. All members of the research team were involved in the design of this study.
Recruitment
At the first research site (Royal Bournemouth hospital), when a new patient enters the stroke unit, the care team will assess whether the patients is suitable to receive Lokomat training (as per standard care). If the patient is going to receive Lokomat training, and they satisfy the inclusion criteria of the study (assessed by a member of the clinical care team), a member of the care team will then explain the study to the participant, and provide an information sheet to the patient. They will then have an opportunity to ask any questions they have to either the care team or the research team. If they then decide that they want to participate, then informed written consent will be obtained by a member of the care team.
Study participation will not influence which patients are offered or receive RAGT. The patients will not be offered any extra or any fewer sessions if they do or do not decide to participate in the study, and it will be made clear that participation will not influence the care they receive in any way.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pulse wave velocity (carotid-femoral)
时间窗: All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment)
The change in pulse wave velocity (carotid-femoral pulse wave velocity) over the first three months post-stroke
次要结局
- Peripheral blood pressure(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Step count(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Time spent walking(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Central blood pressure(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Pulse wave velocity (brachial-ankle)(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Time spent lying(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Time spent sitting(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Time spent standing(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Timed up-and-go (TUG) test(TUG results will be reported at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Number of steps RAGT facilitated(The ActivPAL accelerometer will be worn for 3 days at a time at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment).)
- 2-minute walk test (2MWT)(2MWT results will be reported at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Number of sit to stand transitions(All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))
- Functional Ambulation Category (FAC)(Functional Ambulation Classification scores will be reported at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment))