Ischemic StrokeNCT04972812
The Effects of Posture on Cerebral Blood Flow Velocity During the Acute Phase of Stroke
An observational study of Ischemic Stroke and Haemorrhagic Stroke, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
After stroke, blood vessels in the brain can become damaged, and the brain's ability to control blood flow can be impaired. The brain therefore may be less able to maintain a healthy level of blood flow during challenges such as changes in posture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Haemorrhagic Stroke, Cerebrovascular Accident
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute stroke inpatients
Who may be able to join
- Adult (age ≥18 years) patients diagnosed with any subtype of stroke (first or recurrent).
- Medically stable, assessed by a stroke physician.
- Able to be enrolled between within 7 days of stroke symptom onset.
- Able to sit independently.
- Able to stand with or without assistance.
- Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions.
Who cannot join
- Autonomic nervous system disorder causing haemodynamic instability e.g. pure autonomic failure, Parkinson's disease, multiple system atrophy and Shy-Drager syndrome
- Lower-limb pain when standing.
- Restricted range of motion due to spasticity or contracture impairing ability to stand.
- Orthopaedic impairment (e.g. bone fracture or ligament rupture) preventing prevent full weight bearing activities.
- Resting systolic blood pressure ≤100 mmHg or ≥180 mmHg.
- Resting diastolic blood pressure ≤50 mmHg or ≥120 mmHg.
Show all 12Show fewer
- Significant tachycardia ≥120 beats per minute at rest.
- Significant bradycardia ≤40 beats per minute at rest.
- Peripheral oxygen saturation ≤85% without use of supplementary oxygen.
- Life expectancy <6 months (terminal illness).
- Currently participating in another clinical trial that is likely to affect outcome measures (e.g. experimental drug that affects blood pressure or blood vessel tone).
- Likely to be discharged from hospital or repatriated within 48 hours of stroke onset.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
After stroke, blood vessels in the brain can become damaged, and the brain's ability to control blood flow can be impaired. The brain therefore may be less able to maintain a healthy level of blood flow during challenges such as changes in posture. Studies have shown that sitting upright early after stroke can cause brain blood flow to reduce. However, no studies have investigated how standing up affects blood flow to the brain. In this study, transcranial Doppler ultrasound will be used to assess how cerebral blood flow velocity changes when acute stroke patients stand up.
Read the detailed description
Introduction
Clinical guidelines recommend that some stroke survivors should engage in out-of-bed sitting, standing and walking activities early after stroke. Studies have found that compared to lying flat, sitting upright reduces brain blood flow early after stroke. However, no research has been done to find out how standing affects brain blood flow early after stroke. The transition from sitting to standing causes blood to move away from the head toward the legs, which can lower blood pressure and brain blood flow. In healthy individuals, blood vessels in the brain respond to reduced blood flow and blood pressure by dilating (widening), diverting more blood to the brain. After a stroke, the blood vessels in the brain can become damaged and their ability to control blood flow can be impaired. This raises the concern that standing early after a stroke could cause brain blood flow to drop too low which may worsen the brain injury. A recent large-scale trial reported that starting rehabilitation activities (including standing) earlier (18.5 hours vs 22.4 hours after stroke) resulted in poorer recovery of physical function measured three months after stroke. Lowered brain blood flow, caused by standing, may have contributed to this negative outcome. However, the effects of standing on brain blood flow early after stroke have not yet been investigated. This study will investigate the effects of standing on cerebral blood flow velocity, measured using transcranial Doppler ultrasound, within 1-7 days of stroke onset.
Participants
People with acute ischaemic or haemorrhagic stroke admitted to the Royal Hallamshire Hospital (Sheffield, England) will be recruited to this study after providing informed consent.
Mobilisation Protocol
Participants will be asked to rest in a semi-recumbent position in their hospital bed, with their head resting on a pillow. A transcranial Doppler ultrasound (TCD) device (Viasys Sonara, Viasys Healthcare Inc., USA) will then be fixed to the head using a lightweight, comfortable headset. A heart rate monitor (Polar H10, Polar Electro, UK) will then be fitted around the upper torso, directly below the sternum, using an elasticated strap containing built-in electrodes. A blood pressure cuff (Dinamap, GE Heathcare Systems Inc., USA) will then be fitted on the left arm, over the brachial artery. Participants will then be lowered to a supine position (0˚), and baseline cerebral blood flow (CBF) velocity, heart rate and blood pressure (BP) measures will be recorded after five minutes of rest. CBF velocity, heart rate and BP will be then be assessed in the following positions: semi-recumbent (30˚), sitting upright (90˚) and standing. Participants will spend three minutes in each position. A bedside remote control will be used to increase the bed angle from 0˚ to 30˚ over a period of 10 seconds (~3˚ per second); the participant will not be required to lift their head away from the pillow during the first transition (0˚ to 30˚). After three minutes spent at 30˚, the participant will be asked to move to an upright sitting position (90˚) with their legs hanging over the edge of the hospital bed (feet in contact with the floor), with assistance provided by a healthcare professional. After three minutes of sitting upright, the participant will be asked to move into a standing position, with assistance provided by a healthcare professional. Participants will be given as much time as they need to move into sitting and standing positions. After three minutes of standing, participants will be asked to sit in a chair which has a backrest while the TCD headset, heart rate strap and BP cuff are removed. This will be the end of the study visit, and usual care rehabilitation activities will continue as normal thereafter. During the mobilisation protocol, CBF velocity and heart rate will be recorded continuously whereas BP will be measured at the first and third minute in each position in accordance with the timeframes used to measure transient and delayed orthostatic hypotension, respectively. Signs or symptoms of light-headedness and deterioration of motor, cognitive or sensory function will be recorded. As this is a pragmatic, observational study, the study visit time of day will not be standardised.
- Keywords
- Orthostatic hypotension, Orthostatic stress, Cerebral blood flow, Early mobilisation, Standing, Posture
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Acute stroke patients receiving usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow velocity (cm/s^1)
Absolute change in bilateral mean middle cerebral artery velocity (cm/s^1)
Measured: Day 1 (measured over a 14-minute period)
Secondary outcomes (6)
Change in cerebral blood flow velocity (%)
Relative change in bilateral mean middle cerebral artery velocity (%)
Measured: Day 1 (measured over a 14-minute period)
Change in blood pressure
Absolute change in mean arterial pressure (mmHg)
Measured: Day 1 (measured over a 14-minute period)
Change in heart rate
Absolute change in heart rate (beats per minute)
Measured: Day 1 (measured over a 14-minute period)
Disability
Modified Rankin Scale (0-5; 0 = no symptoms at all, 5 = severe disability)
Measured: Day 1 (at study enrollment) & 3 months post-stroke
Functional independence
Barthel Index (0-100; <20 = totally dependent, 80-100 = independent)
Measured: Day 1 (at study enrollment) & 3 months post-stroke
Adverse events
- Secondary stroke.
- Falls.
- Cardiovascular events.
- Death.
Measured: 3 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jul 2021
- Primary completion31 May 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Simon Nichols, Sheffield Hallam University
- Investigators
- Simon Nichols, PhD, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972812
- Sponsor's protocol ID
- STH21782
- Status last verified
- Sep 2022
- First submitted
- 12 Jul 2021
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will have exclusive access to the data for 24 months after the end date of the study whilst we develop a protocol and grant application, and publish our findings. Data will be accessible before 24 months should these objectives be achieved earlier than expected. Anonymised data will be provided on application rather than be offered open access. A description of the data will be placed on the University open access repository (SHURDA). Data sharing will be subject to an application. No sensitive/personal data will be made available. All external users of our data will be bound by a data sharing agreement between the research team, the University, and the user themselves. Data will be supplied on the condition that their research is non-profit, and that their findings will be published in an open access domain. Data users will not be permitted to share the data with anyone outside of their immediate research team.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Posture on Cerebral Blood Flow Velocity During the Acute Phase of Stroke
- ClinicalTrials.gov ID
- NCT04972812
- Acronym / sponsor ID
- STH21782
- Keywords
- Orthostatic hypotension, Orthostatic stress, Cerebral blood flow, Early mobilisation, Standing, Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After stroke, blood vessels in the brain can become damaged, and the brain's ability to control blood flow can be impaired. The brain therefore may be less able to maintain a healthy level of blood flow during challenges such as changes in posture. Studies have shown that sitting upright early after stroke can cause brain blood flow to reduce. However, no studies have investigated how standing up affects blood flow to the brain. In this study, transcranial Doppler ultrasound will be used to assess how cerebral blood flow velocity changes when acute stroke patients stand up.
Detailed description
Introduction
Clinical guidelines recommend that some stroke survivors should engage in out-of-bed sitting, standing and walking activities early after stroke. Studies have found that compared to lying flat, sitting upright reduces brain blood flow early after stroke. However, no research has been done to find out how standing affects brain blood flow early after stroke. The transition from sitting to standing causes blood to move away from the head toward the legs, which can lower blood pressure and brain blood flow. In healthy individuals, blood vessels in the brain respond to reduced blood flow and blood pressure by dilating (widening), diverting more blood to the brain. After a stroke, the blood vessels in the brain can become damaged and their ability to control blood flow can be impaired. This raises the concern that standing early after a stroke could cause brain blood flow to drop too low which may worsen the brain injury. A recent large-scale trial reported that starting rehabilitation activities (including standing) earlier (18.5 hours vs 22.4 hours after stroke) resulted in poorer recovery of physical function measured three months after stroke. Lowered brain blood flow, caused by standing, may have contributed to this negative outcome. However, the effects of standing on brain blood flow early after stroke have not yet been investigated. This study will investigate the effects of standing on cerebral blood flow velocity, measured using transcranial Doppler ultrasound, within 1-7 days of stroke onset.
Participants
People with acute ischaemic or haemorrhagic stroke admitted to the Royal Hallamshire Hospital (Sheffield, England) will be recruited to this study after providing informed consent.
Mobilisation Protocol
Participants will be asked to rest in a semi-recumbent position in their hospital bed, with their head resting on a pillow. A transcranial Doppler ultrasound (TCD) device (Viasys Sonara, Viasys Healthcare Inc., USA) will then be fixed to the head using a lightweight, comfortable headset. A heart rate monitor (Polar H10, Polar Electro, UK) will then be fitted around the upper torso, directly below the sternum, using an elasticated strap containing built-in electrodes. A blood pressure cuff (Dinamap, GE Heathcare Systems Inc., USA) will then be fitted on the left arm, over the brachial artery. Participants will then be lowered to a supine position (0˚), and baseline cerebral blood flow (CBF) velocity, heart rate and blood pressure (BP) measures will be recorded after five minutes of rest. CBF velocity, heart rate and BP will be then be assessed in the following positions: semi-recumbent (30˚), sitting upright (90˚) and standing. Participants will spend three minutes in each position. A bedside remote control will be used to increase the bed angle from 0˚ to 30˚ over a period of 10 seconds (~3˚ per second); the participant will not be required to lift their head away from the pillow during the first transition (0˚ to 30˚). After three minutes spent at 30˚, the participant will be asked to move to an upright sitting position (90˚) with their legs hanging over the edge of the hospital bed (feet in contact with the floor), with assistance provided by a healthcare professional. After three minutes of sitting upright, the participant will be asked to move into a standing position, with assistance provided by a healthcare professional. Participants will be given as much time as they need to move into sitting and standing positions. After three minutes of standing, participants will be asked to sit in a chair which has a backrest while the TCD headset, heart rate strap and BP cuff are removed. This will be the end of the study visit, and usual care rehabilitation activities will continue as normal thereafter. During the mobilisation protocol, CBF velocity and heart rate will be recorded continuously whereas BP will be measured at the first and third minute in each position in accordance with the timeframes used to measure transient and delayed orthostatic hypotension, respectively. Signs or symptoms of light-headedness and deterioration of motor, cognitive or sensory function will be recorded. As this is a pragmatic, observational study, the study visit time of day will not be standardised.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual care | – | –Acute stroke patients receiving usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute stroke inpatients
Key inclusion criteria (6 listed)
- Adult (age ≥18 years) patients diagnosed with any subtype of stroke (first or recurrent).
- Medically stable, assessed by a stroke physician.
- Able to be enrolled between within 7 days of stroke symptom onset.
- Able to sit independently.
- Able to stand with or without assistance.
Key exclusion criteria (12 listed)
- Autonomic nervous system disorder causing haemodynamic instability e.g. pure autonomic failure, Parkinson's disease, multiple system atrophy and Shy-Drager syndrome
- Lower-limb pain when standing.
- Restricted range of motion due to spasticity or contracture impairing ability to stand.
- Orthopaedic impairment (e.g. bone fracture or ligament rupture) preventing prevent full weight bearing activities.
- Resting systolic blood pressure ≤100 mmHg or ≥180 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cerebral blood flow velocity (cm/s^1)
Time frame: Day 1 (measured over a 14-minute period)
Absolute change in bilateral mean middle cerebral artery velocity (cm/s^1)
6 secondary outcomes
Change in cerebral blood flow velocity (%)
Time frame: Day 1 (measured over a 14-minute period)
Change in blood pressure
Time frame: Day 1 (measured over a 14-minute period)
Change in heart rate
Time frame: Day 1 (measured over a 14-minute period)
Disability
Time frame: Day 1 (at study enrollment) & 3 months post-stroke
Functional independence
Time frame: Day 1 (at study enrollment) & 3 months post-stroke
Adverse events
Time frame: 3 months post-stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Yes. We will have exclusive access to the data for 24 months after the end date of the study whilst we develop a protocol and grant application, and publish our findings. Data will be accessible before 24 months should these objectives be achieved earlier than expected. Anonymised data will be provided on application rather than be offered open access. A description of the data will be placed on the University open access repository (SHURDA). Data sharing will be subject to an application. No sensitive/personal data will be made available. All external users of our data will be bound by a data sharing agreement between the research team, the University, and the user themselves. Data will be supplied on the condition that their research is non-profit, and that their findings will be published in an open access domain. Data users will not be permitted to share the data with anyone outside of their immediate research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Nichols, PhD principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Haemorrhagic Stroke, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral blood flow velocity (cm/s^1) (time frame: Day 1 (measured over a 14-minute period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.