Stroke Clinical Trial
Official title:
The Effect of Robot-assisted Gait Training on Cardiovascular Health and Activity Levels Within Early-subacute Stroke Patients
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: 1. Independently mobile (with or without an aid) prior to the stroke 2. FAC (Functional Ambulation Category) score of 0-2 at baseline 3. Cardiovascularly stable as determined by the medical team (heart and blood pressure is stable) 4. Able to tolerate being upright for at least 30 minutes and participate in active therapy Exclusion criteria: 1. If participants have any contraindications related to Lokomat use, as per the manufacturers (Hocoma) guidance. The contraindications in full can be found on the HOCOMA website (https://www.hocoma.com/legal- notes/#lokomatpro_lokomatnanos). The most relevant contraindications are: - Any known diagnosis of low bone mineral density - Over 2 metres tall - Over 135kg - Non-consolidated fractures - Any medical condition preventing active rehabilitation (e.g., respiratory disease, pregnancy, neuropsychological conditions) - Fixed joint contractures that limit the range of motion of the orthosis - Upper leg length of less than 35cm and more than 47cm - Any condition or situation which prohibits the proper adjustment of the harness and/or orthosis (e.g., pregnancy, colostomy bags, skin lesions that cannot be protected appropriately). 2. If patients do not have the capacity to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Bournemouth Hospital | Bournemouth | |
United Kingdom | Royal Hampshire County Hospital | Winchester |
Lead Sponsor | Collaborator |
---|---|
University of Winchester | Hampshire Hospitals NHS Foundation Trust, University Hospitals Dorset NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulse wave velocity (carotid-femoral) | The change in pulse wave velocity (carotid-femoral pulse wave velocity) over the first three months post-stroke | 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) | |
Secondary | Central blood pressure | The change in central blood pressures over time, which will be measures by using the Vicorder. | 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) | |
Secondary | Peripheral blood pressure | The change in peripheral blood pressures over time, which will be measures by using the Vicorder. | 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) | |
Secondary | Pulse wave velocity (brachial-ankle) | The change in pulse wave velocity (brachial-ankle) over time, measured by using the Vicorder. | 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) | |
Secondary | Step count | The step count of participants will be measured via the ActivPAL accelerometer. At each assessment point, the participant will wear the device for three days. The change in steps taken will be assessed over the 3-month period. | 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) | |
Secondary | Number of sit to stand transitions | The number of sit to stand transitions will be measured via the ActivPAL accelerometer. At each assessment point, the participant will wear the device for three days. The change in the number of sit to stand transitions will be assessed over the 3-month period. | 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) | |
Secondary | Time spent lying | The time spent lying will be measured via the ActivPAL accelerometer. At each assessment point, the participant will wear the device for three days. The change in time spent lying will be assessed over the 3-month period. | 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) | |
Secondary | Time spent sitting | The time spent sitting will be measured via the ActivPAL accelerometer. At each assessment point, the participant will wear the device for three days. The change in time spent sitting will be assessed over the 3-month period. | 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) | |
Secondary | Time spent standing | The time spent standing will be measured via the ActivPAL accelerometer. At each assessment point, the participant will wear the device for three days. The change in time spent standing will be assessed over the 3-month period. | 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) | |
Secondary | Time spent walking | The time spent walking will be measured via the ActivPAL accelerometer. At each assessment point, the participant will wear the device for three days. The change in time spent walking will be assessed over the 3-month period. | 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) | |
Secondary | Functional Ambulation Category (FAC) | The changes in Functional Ambulation Classification score will be assessed over the 3-month period. The Functional Ambulation Classification is scored from 0 to 5, with higher scores representing better outcomes. | 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) | |
Secondary | Timed up-and-go (TUG) test | The changes in TUG results over the 3-month period will be assessed. | 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) | |
Secondary | 2-minute walk test (2MWT) | The changes in distance walked during the 2MWT over the 3-month period will be assessed. | 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) | |
Secondary | Number of steps RAGT facilitated | The average number of steps taken per RAGT session will be analysed and compared to the average number of steps taken during each conventional physiotherapy session completed while the ActivPAL was worn over the study duration (3 months). | 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). |
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