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Head Position in Acute Stroke Trial

An investigator-initiated and conducted, international, multicentre, cluster, randomised cross-overcontrolled trial to establish the comparative effectiveness of different head positioning in patients with acute stroke - HEADPoST

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006738
Enrollment
19500
Registered
2016-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- All acute stroke patients admitted to the hospital

Interventions

Intervention1: The lying flat (0°) head position for one cluster group followed by the sitting-up (greater than or equal to 30°) head position: The lying flat (0°) head position: the intervention i
it is possible for patients to eat on their side in the flat position as swallow is an active process that is not dependent on gravity. The sitting-up (greater than or equal to 30°) head position â??

Sponsors

National Health and Medical Research Council of Australia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • are adults aged greater than or equal to 18 years(the age for adults may vary in different countries) • have a presumed clinical diagnosis of acute stroke (i.e. with a persistent neurological deficit on presentation), • present to hospital, or have an in-hospital event or transfer from another hospital, with acute stroke.

Exclusion criteria

Exclusion criteria: • transient ischaemic attack (TIA) (i.e. symptoms have resolved upon presentation), • definite clinical contraindication or indication to either the sitting up or lying flat head positions, • significant medical condition that takes priority in care and where adherence to the randomised head position is not possible on another ward/department of the hospital, • immediate transfer from the ED or admission, to another ward for medical treatment (e.g. for haemodialysis) or surgery (e.g. carotid endarterectomy, haematoma evacuation) where adherence to the randomised head position is not possible.

Design outcomes

Secondary

MeasureTime frame
1. Death or dependency measured by a shift in NIHSS(46) at 7 days 2. Death within 90 days 3. Length of hospital stay 4. the European Quality of Life Scale 5 Dimension (EQ-5D) 5. Pneumonia according to standard criteria involving a set combination of symptomatology and radiological signs Timepoint: 1. Death or dependency at 7 days 2. Death within 90 days 3. Pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission

Primary

MeasureTime frame
primary outcome will be a shift (improvement) in death and disability according to the patientâ??s modified Rankin Score (mRS) at 90 days.Timepoint: 90 days

Countries

Australia, Brazil, Chile, China, India, Sri Lanka, Taiwan, United Kingdom, United States of America

Contacts

Public ContactJeyaraj Durai Pandian

Christian Medical College, Ludhiana

jeyarajpandian@hotmail.com9915784750

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026