The Effects of Posture on Cerebral Blood Flow Velocity During the Acute Phase of Stroke

NCT04972812 | Completed

• 1 other identifier: STH21782
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke; Haemorrhagic Stroke; Cerebrovascular Accident; Acute Stroke

Keywords

Orthostatic hypotension; Orthostatic stress; Cerebral blood flow; Early mobilisation; Standing; Posture

Outcome Measures

Primary Outcomes (1)

• Change in cerebral blood flow velocity (cm/s^1)

  Absolute change in bilateral mean middle cerebral artery velocity (cm/s\^1)

  Day 1 (measured over a 14-minute period)

Secondary Outcomes (6)

• Change in cerebral blood flow velocity (%)

  Day 1 (measured over a 14-minute period)

• Change in blood pressure

  Day 1 (measured over a 14-minute period)

• Change in heart rate

  Day 1 (measured over a 14-minute period)

• Disability

  Day 1 (at study enrollment) & 3 months post-stroke

• Functional independence

  Day 1 (at study enrollment) & 3 months post-stroke

Study Arms (1)

Usual care

Acute stroke patients receiving usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute stroke inpatients

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Stroke; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension

Study Officials

• Simon Nichols, PhD

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Clinical study report: \<24 months after trial end date.
• Access Criteria: Data sharing enquires may be sent to Dr Simon Nichols, s.j.nichols@shu.ac.uk.

Locations

GB (1)