StrokePRESERVENCT07212738
Post-stroke REhabilitation Start Evaluation for Reducing Vascular Events
A study testing Delayed mobilization (DeM) in people with Stroke and Ischemic Stroke, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this research study is to better understand when to start rehabilitation therapies after acute ischemic stroke to prevent further harm to the brain and to improve outcomes for stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke
- What is being tested?
- Delayed mobilization (DeM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participants with acute ischemic stroke presenting to Foothills Medical Centre meeting eligibility for intravenous thrombolysis (Tenecteplase, TNK) - ≥18 years of age presenting within 4.5 hours of symptom onset with a diagnosis of suspected acute ischemic stroke causing significant neurological disability - and/or endovascular thrombectomy (EVT).
- Age ≥18 years.
- Persistent vessel occlusion will be defined as any of the following:
- EVT treatment of medium or large intracranial vessel occlusion with a thrombolysis in cerebral infarction (TICI) score of ≤2b.
- A moderate infarct core (ASPECTS ≤5) despite TICI 3.
- 24-hour CT with evidence of hyperdense sign appropriate to clinical deficits.
Who cannot join
- Comorbid conditions limiting recovery or life expectancy (e.g., significant cognitive impairment, stage IV cancer, end-stage renal disease).
- Low pre-stroke baseline functional status (mRS ≥4).
- Symptoms due to another acute neurological condition (e.g., migraine with aura, seizure) or neurological deficits secondary to metabolic/toxic derangements (e.g., hyponatremia, hypoglycemia).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Sean P Dukelow, MD, PhD, 403-944-2061, sean.dukelow@albertahealthservices.ca
Andrea M Kuczynski, MD, PhD, andrea.kuczynski@albertahealthservices.ca
About this study
Official title: Post-stroke REhabilitation Start Evaluation for Reducing Vascular Events (PRESERVE)
The purpose of this research study is to better understand when to start rehabilitation therapies after acute ischemic stroke to prevent further harm to the brain and to improve outcomes for stroke survivors.
Stroke is the second leading cause of death and reduced quality of life worldwide, with one Canadian diagnosed with stroke every five minutes. The most common subtype, ischemic stroke, occurs when a blood vessel in the brain is blocked. Hyperacute treatments aim to remove these blockages to restore blood flow and improve deficits, but in some cases, this is not achieved and leads to persistent large or medium intracranial vessel occlusion.
Read more
After stroke, early medical and physical care can reduce physical and cognitive impairment and improve long-term functional outcomes. Prolonged immobilization can cause secondary complications and make recovery more difficult. Other research studies have demonstrated varying results with both benefit and no difference in the long-term level of functional independence when starting physical activity between 24 to 48 hours after acute ischemic stroke. The optimal timing for mobilization is unclear especially for patients with persistent vessel occlusion large stroke size, or intracranial hemorrhage, where starting active therapy too soon can cause additional harm by damaging the brain further.
In this research study, the investigators aim to evaluate the feasibility and effect of delayed mobilization (DeM), defined as physical therapy starting on or after day 3 from stroke symptom onset, on stroke volume growth and functional outcomes in patients with persistent vessel occlusion. The investigators think that individuals who still have evidence of persistent blockage in their arteries may benefit from waiting until day 3 after stroke to begin rehabilitation.
Improving care strategies for stroke survivors will ultimately benefit individuals, their families, and healthcare systems. This study may guide the optimal timing of initiating stroke rehabilitation in patients with persistent vessel occlusion and ischemia to improve recovery times and reduce long-term disabilities.
Read the detailed description
While stroke remains the world's second leading cause of death and reduced quality of life in adults, mortality and disability have decreased over the years with advances in acute care and improvements in risk stratification (1). Ischemic stroke is the most common stroke subtype, caused by a blockage of blood flow in an artery in the brain. Revascularization interventions aiming to restore blood flow include intravenous thrombolysis and endovascular thrombectomy and have evidence in reducing the likelihood of long-term disability when performed rapidly in patients presenting early and without contraindications (2-4). Traditionally, functional independence is measured at 90 days after stroke using the modified Rankin scale (mRS) (5), where a score of 0 to 2 indicates limited impairment.
Early multidisciplinary care is essential for reducing physical and cognitive impairment following stroke, and in improving the chances of functional independence in the long-term. Immobilization for prolonged periods of time can result in secondary complications that further negatively impact recovery, including pneumonia, deep venous thrombosis, delirium, reduced muscle mass, and joint contractures (6). These secondary complications not only limit recovery, but increase the risk of mortality after stroke. Physical rehabilitation after stroke includes sitting, standing, supported ambulation, and repetitive body strength training with registered physiotherapists and occupational therapists. Early mobilization after stroke has been defined as starting physical rehabilitation between 24 to 48 hours after stroke onset, while some have proposed that very early (7) mobilization occurring within 12 hours of stroke onset has benefit.
Evidence for early or very early mobilization suggest that proteins associated with endogenous neural repair and growth-promoting factors are altered within the first few weeks after ischemic stroke (8-10). As a result, the upregulation in these processes may provide greater neuroplasticity for the injured brain to greater enhance its responsiveness to rehabilitation (11-13), and subsequently improve outcomes for stroke survivors. However, animal studies have also observed that starting exercise 6 hours after infarction raises pro-inflammatory cytokines and pro-apoptotic proteins leading to aggravated brain injury (14-15). The best timing for mobilization remains unclear when considering individual stroke factors such as persistent vessel occlusion (PVO), size of the ischemic core, or presence of intracranial hemorrhage, where active therapy can cause harm by increasing ischemic depolarization and reducing cerebral blood flow.
Clinically, the evidence regarding the timing of mobilization is additionally controversial. Studies have demonstrated both benefit (7,11,16-17) and no difference (18-22) in the level of functional independence following early mobilization between 24 to 48 hours after acute stroke when compared to individuals who received active therapy starting at 72 to 96 hours after stroke onset. More recently, the AVERT trial found a decrease in the odds of good outcomes (mRS score 0-2) at 3 months when mobilizing survivors within 24 hours of acute ischemic stroke (21). These findings are likely explained by their heterogenous sample including patients with PVO of large or medium caliber. Despite advances in stroke care and prevention, determining the optimal time to start physical activity after stroke to balance the risks of increasing stroke growth versus providing stroke survivors the best chance for greater independence is unknown.
Rehabilitation is crucial for reducing post-stroke disability and improving functional independence (23). The exact timing, however, on when to initiate rehabilitation after stroke is unclear. In some cases, starting rehabilitation immediately and very early after stroke (i.e., within 24 hours) can result in growth of the infarcted brain tissue due to cerebral hypoperfusion, resulting in worse clinical outcomes (21). In the present study, the investigators aim to determine the optimal timing of when to start active therapy after ischemic stroke by comparing a model of delayed mobilization (active therapy starting on or after day 3 post-stroke) to standardize care (active therapy starting by day 2 post-stroke). The investigators aim to determine the impacts of delayed mobilization on stroke volume growth, secondary brain injuries including hemorrhagic transformation and tissue hypoperfusion, and clinical measures of independence.
References
- Donkor ES. Stroke in the 21st century: a snapshot of the burden, epidemiology, and quality of life. Stroke Res Treat. Nov 27, 2018;2018:3238165. doi:10.1155/2018/ 3238165.
- Boulanger J, Lindsay M, Gubitz G, et al; Canadian stroke best practice recommendations for acute stroke management: prehospital, emergency department, and acute inpatient stroke care, update 2018. International Journal of Stroke. 2018;13(9):949-984.
- Powers WJ, Rabinstein AA, Ackerson T, et al; Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2019;50(12):e344-e418.
- National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. New England Journal of Medicine. 1995;333(24):1581-1588.
- Quinn TJ, Dawson J, Walters MR, Less KR. Functional outcome measures in contemporary stroke trials. Int J Stroke. 2009;4:200-206.
- Bamford J, Dennis M, Sandercock P, Burn J, Warlow C. The frequency, causes and timing of death within 30 days of a first stroke: the Oxfordshire community stroke project. J Neurol Neurosurg Psychiatry. 1990;53(10):824-829.
- Yanase L, Clark D, Baraban E, Stuchiner T. A Retrospective Analysis of Ischemic Stroke Patients Supports That Very Early Mobilization Within 24 Hours After Intravenous Alteplase Is Safe and Possibly Beneficial. J Neurosci Nurs. 2023 Dec 1;55(6):188-193.
- Stroemer RP, Kent TA, Hulsebosch CE. Neocortical neural sprouting, synaptogenesis, and behavioral recovery after neocortical infarction in rats. Stroke. 1995;26:2135-2144.
- Kawamata T, Alexis NE, Dietrich WD, Finklestein SP. Intracisternal basic fibroblast growth factor enhances behavioral recovery following focal cerebral infarction in the rat. J Cereb Blood Flow Metab. 1996;16:542-547.
- Dahlqvist P, Zhao L, Johansson IM, Mattsson B, Johansson BB. Environmental enrichment alters nerve growth factor-induced gene A and glucocorticoid receptor messenger RNA expression after middle cerebral artery occlusion in rats. Neuroscience. 1999;93:527-535.
- Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54.
- Dimyan MA, Cohen LG. Neuroplasticity in the context of motor rehabilitation after stroke. Nat Rev Neurol. 2011;7(2):76-85.
- Johansson BB. Brain plasticity and stroke rehabilitation. The Willis lecture. Stroke. 2000;31(1):223-230.
- Li F, Pendy JT Jr, Ding JN, Peng C, Li X, Shen J, Wang S, Geng X. Exercise rehabilitation immediately following ischemic stroke exacerbates inflammatory injury. Neurol Res. 2017;39(6):530-537.
- Shen J, Huber M, Zhao EY, Peng C, Li F, Li X, Geng X, Ding Y. Early rehabilitation aggravates brain damage after stroke via enhanced activation of nicotinamide adenine dinucleotide phosphate oxidase (NOX). Brain Res. 2016;1648:266-276.
- Wang F, Zhang S, Zhou F, Zhao M, Zhao H. Early physical rehabilitation therapy between 24 and 48 h following acute ischemic stroke onset: a randomized controlled trial. Disabil Rehabil. 2022;44(15):3967-3972.
- Langhorne P, Stott D, Knight A, Bernhardt J, Barer D, Watkins C. Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial. Cerebrovasc Dis. 2010;29(4):352-360.
- Anjos JM, Neto MG, de Araújo Tapparelli Y, Tse G, Biondi-Zoccai G, de Souza Lima Bitar Y, Roever L, Duraes AR. Efficacy and safety of very early mobilization after thrombolysis in acute ischemic stroke: a randomized clinical trial. J Neurol. 2023 Feb;270(2):843-850.
- Sundseth A, Thommessen B, Ronning OM. Early mobilization after acute stroke. J Stroke Cerebrovasc Dis. 2014;23(3):496-499.
- Sundseth A, Thommessen B, Ronning OM. Outcome after mobilization within 24 hours of acute stroke: a randomized controlled trial. Stroke. 2012;43(9):2389-2394.
- AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55.
- Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G. A Very Early Rehabilitation Trial for Stroke (AVERT): phase II safety and feasibility. Stroke. 2008;39:390-396.
- Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, et al. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014;9(2):e87987.
- Conditions
- Stroke, Ischemic Stroke
- Being tested
- Delayed mobilization (DeM), Standard Care (in control arm)
- Keywords
- stroke, rehabilitation, neuroimaging
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed mobilization (DeM)Other
Also called Standard care
Delayed mobilization (group 1): active therapy beginning ≥3 days from symptom onset.
Standard Care (in control arm)Other
Standard care (group 2): allied health assessment by 48 hours post-stroke followed by initiation of therapy at routine intensity (approximately 20 minutes/day of occupational and 20 minutes/day of physiotherapy). Therapy will depend on the level of disability of the participant, but will include working on standing, stepping, walking, balancing, self-care (i.e., grooming, dressing), functional task training (i.e., self-feeding), and addressing any cognitive and/or perceptive deficits.
Active therapy will be conducted by the Foothills Medical Centre stroke unit (Calgary, AB, Canada) certified physiotherapists and occupational therapists. The allied health team will not be blinded to the randomization of participants.
| Study group | Role | What they receive |
|---|---|---|
| Delayed mobilization (DeM) | Experimental | Active therapy beginning ≥3 days from stroke symptom onset. Receives: Other: Delayed mobilization (DeM) |
| Standard care | Active comparator | Allied health assessment by 48 hours post-stroke followed by initiation of therapy at routine intensity (approximately 20 minutes/day of occupational and 20 minutes/day of physiotherapy). Therapy will depend on the level of disability of the participant, but will include working on standing, stepping, walking, balancing, self-care (i.e., grooming, dressing), functional task training (i.e., self-feeding), and addressing any cognitive and/or perceptive deficits. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of delayed mobilization.
Our primary outcome will be completion of the trial to determine whether delaying mobilization is feasible.
Measured: Participants will be assessed for up to 3 months post-stroke, predominantly on their 7 day admission and at their 3-month outpatient follow-up (8 total days).
Secondary outcomes (1)
Incidence of secondary neurovascular injury.
The secondary objective is to determine the incidence of secondary neurovascular injury (i.e., infarct growth and/or hemorrhagic transformation) in individuals with delayed mobilization. MRI brain scans at 1-2 day after admission to hospital and on day 7 after stroke will be used to measure stroke volume growth following intervention, comparing the metrics to the baseline scans.
Measured: Neuroimaging outcomes will be compared from admission (day 1-2 post-stroke) to repeat MRI on day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of two groups after admission to hospital: 1. Delayed care (group 1): active therapy beginning ≥3 days from symptom onset. 2. Standard care (group 2): allied health assessment by 48 hours post-stroke followed by initiation of therapy at routine intensity (approximately 20 minutes/day of occupational and 20 minutes/day of physiotherapy). Therapy will depend on the level of disability of the participant, but will include working on standing, stepping, walking, balancing, self-care (i.e., grooming, dressing), functional task training (i.e., self-feeding), and addressing any cognitive and/or perceptive deficits.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed A Almekhlafi, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212738
- Sponsor's protocol ID
- REB25-0152
- Other IDs
- 10040548
- Acronym
- PRESERVE
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stroke REhabilitation Start Evaluation for Reducing Vascular Events (PRESERVE)
- ClinicalTrials.gov ID
- NCT07212738
- Acronym / sponsor ID
- PRESERVE / REB25-0152
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- stroke, rehabilitation, neuroimaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Oct 2025 (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.
The purpose of this research study is to better understand when to start rehabilitation therapies after acute ischemic stroke to prevent further harm to the brain and to improve outcomes for stroke survivors.
Stroke is the second leading cause of death and reduced quality of life worldwide, with one Canadian diagnosed with stroke every five minutes. The most common subtype, ischemic stroke, occurs when a blood vessel in the brain is blocked. Hyperacute treatments aim to remove these blockages to restore blood flow and improve deficits, but in some cases, this is not achieved and leads to persistent large or medium intracranial vessel occlusion.
After stroke, early medical and physical care can reduce physical and cognitive impairment and improve long-term functional outcomes. Prolonged immobilization can cause secondary complications and make recovery more difficult. Other research studies have demonstrated varying results with both benefit and no difference in the long-term level of functional independence when starting physical activity between 24 to 48 hours after acute ischemic stroke. The optimal timing for mobilization is unclear especially for patients with persistent vessel occlusion large stroke size, or intracranial hemorrhage, where starting active therapy too soon can cause additional harm by damaging the brain further.
In this research study, the investigators aim to evaluate the feasibility and effect of delayed mobilization (DeM), defined as physical therapy starting on or after day 3 from stroke symptom onset, on stroke volume growth and functional outcomes in patients with persistent vessel occlusion. The investigators think that individuals who still have evidence of persistent blockage in their arteries may benefit from waiting until day 3 after stroke to begin rehabilitation.
Improving care strategies for stroke survivors will ultimately benefit individuals, their families, and healthcare systems. This study may guide the optimal timing of initiating stroke rehabilitation in patients with persistent vessel occlusion and ischemia to improve recovery times and reduce long-term disabilities.
Detailed description
While stroke remains the world's second leading cause of death and reduced quality of life in adults, mortality and disability have decreased over the years with advances in acute care and improvements in risk stratification (1). Ischemic stroke is the most common stroke subtype, caused by a blockage of blood flow in an artery in the brain. Revascularization interventions aiming to restore blood flow include intravenous thrombolysis and endovascular thrombectomy and have evidence in reducing the likelihood of long-term disability when performed rapidly in patients presenting early and without contraindications (2-4). Traditionally, functional independence is measured at 90 days after stroke using the modified Rankin scale (mRS) (5), where a score of 0 to 2 indicates limited impairment.
Early multidisciplinary care is essential for reducing physical and cognitive impairment following stroke, and in improving the chances of functional independence in the long-term. Immobilization for prolonged periods of time can result in secondary complications that further negatively impact recovery, including pneumonia, deep venous thrombosis, delirium, reduced muscle mass, and joint contractures (6). These secondary complications not only limit recovery, but increase the risk of mortality after stroke. Physical rehabilitation after stroke includes sitting, standing, supported ambulation, and repetitive body strength training with registered physiotherapists and occupational therapists. Early mobilization after stroke has been defined as starting physical rehabilitation between 24 to 48 hours after stroke onset, while some have proposed that very early (7) mobilization occurring within 12 hours of stroke onset has benefit.
Evidence for early or very early mobilization suggest that proteins associated with endogenous neural repair and growth-promoting factors are altered within the first few weeks after ischemic stroke (8-10). As a result, the upregulation in these processes may provide greater neuroplasticity for the injured brain to greater enhance its responsiveness to rehabilitation (11-13), and subsequently improve outcomes for stroke survivors. However, animal studies have also observed that starting exercise 6 hours after infarction raises pro-inflammatory cytokines and pro-apoptotic proteins leading to aggravated brain injury (14-15). The best timing for mobilization remains unclear when considering individual stroke factors such as persistent vessel occlusion (PVO), size of the ischemic core, or presence of intracranial hemorrhage, where active therapy can cause harm by increasing ischemic depolarization and reducing cerebral blood flow.
Clinically, the evidence regarding the timing of mobilization is additionally controversial. Studies have demonstrated both benefit (7,11,16-17) and no difference (18-22) in the level of functional independence following early mobilization between 24 to 48 hours after acute stroke when compared to individuals who received active therapy starting at 72 to 96 hours after stroke onset. More recently, the AVERT trial found a decrease in the odds of good outcomes (mRS score 0-2) at 3 months when mobilizing survivors within 24 hours of acute ischemic stroke (21). These findings are likely explained by their heterogenous sample including patients with PVO of large or medium caliber. Despite advances in stroke care and prevention, determining the optimal time to start physical activity after stroke to balance the risks of increasing stroke growth versus providing stroke survivors the best chance for greater independence is unknown.
Rehabilitation is crucial for reducing post-stroke disability and improving functional independence (23). The exact timing, however, on when to initiate rehabilitation after stroke is unclear. In some cases, starting rehabilitation immediately and very early after stroke (i.e., within 24 hours) can result in growth of the infarcted brain tissue due to cerebral hypoperfusion, resulting in worse clinical outcomes (21). In the present study, the investigators aim to determine the optimal timing of when to start active therapy after ischemic stroke by comparing a model of delayed mobilization (active therapy starting on or after day 3 post-stroke) to standardize care (active therapy starting by day 2 post-stroke). The investigators aim to determine the impacts of delayed mobilization on stroke volume growth, secondary brain injuries including hemorrhagic transformation and tissue hypoperfusion, and clinical measures of independence.
References
- Donkor ES. Stroke in the 21st century: a snapshot of the burden, epidemiology, and quality of life. Stroke Res Treat. Nov 27, 2018;2018:3238165. doi:10.1155/2018/ 3238165.
- Boulanger J, Lindsay M, Gubitz G, et al; Canadian stroke best practice recommendations for acute stroke management: prehospital, emergency department, and acute inpatient stroke care, update 2018. International Journal of Stroke. 2018;13(9):949-984.
- Powers WJ, Rabinstein AA, Ackerson T, et al; Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2019;50(12):e344-e418.
- National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. New England Journal of Medicine. 1995;333(24):1581-1588.
- Quinn TJ, Dawson J, Walters MR, Less KR. Functional outcome measures in contemporary stroke trials. Int J Stroke. 2009;4:200-206.
- Bamford J, Dennis M, Sandercock P, Burn J, Warlow C. The frequency, causes and timing of death within 30 days of a first stroke: the Oxfordshire community stroke project. J Neurol Neurosurg Psychiatry. 1990;53(10):824-829.
- Yanase L, Clark D, Baraban E, Stuchiner T. A Retrospective Analysis of Ischemic Stroke Patients Supports That Very Early Mobilization Within 24 Hours After Intravenous Alteplase Is Safe and Possibly Beneficial. J Neurosci Nurs. 2023 Dec 1;55(6):188-193.
- Stroemer RP, Kent TA, Hulsebosch CE. Neocortical neural sprouting, synaptogenesis, and behavioral recovery after neocortical infarction in rats. Stroke. 1995;26:2135-2144.
- Kawamata T, Alexis NE, Dietrich WD, Finklestein SP. Intracisternal basic fibroblast growth factor enhances behavioral recovery following focal cerebral infarction in the rat. J Cereb Blood Flow Metab. 1996;16:542-547.
- Dahlqvist P, Zhao L, Johansson IM, Mattsson B, Johansson BB. Environmental enrichment alters nerve growth factor-induced gene A and glucocorticoid receptor messenger RNA expression after middle cerebral artery occlusion in rats. Neuroscience. 1999;93:527-535.
- Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54.
- Dimyan MA, Cohen LG. Neuroplasticity in the context of motor rehabilitation after stroke. Nat Rev Neurol. 2011;7(2):76-85.
- Johansson BB. Brain plasticity and stroke rehabilitation. The Willis lecture. Stroke. 2000;31(1):223-230.
- Li F, Pendy JT Jr, Ding JN, Peng C, Li X, Shen J, Wang S, Geng X. Exercise rehabilitation immediately following ischemic stroke exacerbates inflammatory injury. Neurol Res. 2017;39(6):530-537.
- Shen J, Huber M, Zhao EY, Peng C, Li F, Li X, Geng X, Ding Y. Early rehabilitation aggravates brain damage after stroke via enhanced activation of nicotinamide adenine dinucleotide phosphate oxidase (NOX). Brain Res. 2016;1648:266-276.
- Wang F, Zhang S, Zhou F, Zhao M, Zhao H. Early physical rehabilitation therapy between 24 and 48 h following acute ischemic stroke onset: a randomized controlled trial. Disabil Rehabil. 2022;44(15):3967-3972.
- Langhorne P, Stott D, Knight A, Bernhardt J, Barer D, Watkins C. Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial. Cerebrovasc Dis. 2010;29(4):352-360.
- Anjos JM, Neto MG, de Araújo Tapparelli Y, Tse G, Biondi-Zoccai G, de Souza Lima Bitar Y, Roever L, Duraes AR. Efficacy and safety of very early mobilization after thrombolysis in acute ischemic stroke: a randomized clinical trial. J Neurol. 2023 Feb;270(2):843-850.
- Sundseth A, Thommessen B, Ronning OM. Early mobilization after acute stroke. J Stroke Cerebrovasc Dis. 2014;23(3):496-499.
- Sundseth A, Thommessen B, Ronning OM. Outcome after mobilization within 24 hours of acute stroke: a randomized controlled trial. Stroke. 2012;43(9):2389-2394.
- AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55.
- Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G. A Very Early Rehabilitation Trial for Stroke (AVERT): phase II safety and feasibility. Stroke. 2008;39:390-396.
- Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, et al. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014;9(2):e87987.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two groups after admission to hospital: 1. Delayed care (group 1): active therapy beginning ≥3 days from symptom onset. 2. Standard care (group 2): allied health assessment by 48 hours post-stroke followed by initiation of therapy at routine intensity (approximately 20 minutes/day of occupational and 20 minutes/day of physiotherapy). Therapy will depend on the level of disability of the participant, but will include working on standing, stepping, walking, balancing, self-care (i.e., grooming, dressing), functional task training (i.e., self-feeding), and addressing any cognitive and/or perceptive deficits.
| Arm | Type | Receives |
|---|---|---|
| Delayed mobilization (DeM) | Experimental | Other: Delayed mobilization (DeM)Active therapy beginning ≥3 days from stroke symptom onset. |
| Standard care | Active comparator | Other: Standard Care (in control arm)Allied health assessment by 48 hours post-stroke followed by initiation of therapy at routine intensity (approximately 20 minutes/day of occupational and 20 minutes/day of physiotherapy). Therapy will depend on the level of disability of the participant, but will include working on standing, stepping, walking, balancing, self-care (i.e., grooming, dressing), functional task training (i.e., self-feeding), and addressing any cognitive and/or perceptive deficits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with acute ischemic stroke presenting to Foothills Medical Centre meeting eligibility for intravenous thrombolysis (Tenecteplase, TNK) - ≥18 years of age presenting within 4.5 hours of symptom onset with a diagnosis of suspected acute ischemic stroke causing significant neurological disability - and/or endovascular thrombectomy (EVT).
- Age ≥18 years.
- Persistent vessel occlusion will be defined as any of the following:
Key exclusion criteria (3 listed)
- Comorbid conditions limiting recovery or life expectancy (e.g., significant cognitive impairment, stage IV cancer, end-stage renal disease).
- Low pre-stroke baseline functional status (mRS ≥4).
- Symptoms due to another acute neurological condition (e.g., migraine with aura, seizure) or neurological deficits secondary to metabolic/toxic derangements (e.g., hyponatremia, hypoglycemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed mobilization (DeM)Also: Standard careDelayed mobilization (group 1): active therapy beginning ≥3 days from symptom onset. | Other | Delayed mobilization (DeM) |
| Standard Care (in control arm)Standard care (group 2): allied health assessment by 48 hours post-stroke followed by initiation of therapy at routine intensity (approximately 20 minutes/day of occupational and 20 minutes/day of physiotherapy). Therapy will depend on the level of disability of the participant, but will include working on standing, stepping, walking, balancing, self-care (i.e., grooming, dressing), functional task training (i.e., self-feeding), and addressing any cognitive and/or perceptive deficits. Active therapy will be conducted by the Foothills Medical Centre stroke unit (Calgary, AB, Canada) certified physiotherapists and occupational therapists. The allied health team will not be blinded to the randomization of participants. | Other | Standard care |
Primary outcome
Feasibility of delayed mobilization.
Time frame: Participants will be assessed for up to 3 months post-stroke, predominantly on their 7 day admission and at their 3-month outpatient follow-up (8 total days).
Our primary outcome will be completion of the trial to determine whether delaying mobilization is feasible.
1 secondary outcome
Incidence of secondary neurovascular injury.
Time frame: Neuroimaging outcomes will be compared from admission (day 1-2 post-stroke) to repeat MRI on day 7.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed mobilization (DeM) in people with Stroke and Ischemic Stroke, run by University of Calgary at 1 site in Canada.
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 3 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: opening soon, as of the sponsor's last update on 8 Oct 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delayed mobilization. (time frame: Participants will be assessed for up to 3 months post-stroke, predominantly on their 7 day admission and at their 3-month outpatient follow-up (8 total days).). 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 8 Oct 2025.