Post-stroke REhabilitation Start Evaluation for Reducing Vascular Events

NCT07212738 | Not Yet Recruiting DMC

• 2 other identifiers: REB25-015210040548
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Ischemic Stroke

Keywords

stroke; rehabilitation; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Feasibility of delayed mobilization.

  Our primary outcome will be completion of the trial to determine whether delaying mobilization is feasible.

  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.

  Neuroimaging outcomes will be compared from admission (day 1-2 post-stroke) to repeat MRI on day 7.

Other Outcomes (1)

• Rate of functional independence.

  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).

Study Arms (2)

Delayed mobilization (DeM)

EXPERIMENTAL

Active therapy beginning ≥3 days from stroke symptom onset.

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.

Other: Standard Care (in control arm)

Interventions

Delayed mobilization (DeM) OTHER

Delayed mobilization (group 1): active therapy beginning ≥3 days from symptom onset.

Also known as: Standard care

Delayed mobilization (DeM)

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.

Standard care

Eligibility Criteria

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

You may qualify if:

• 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.
• hour CT with evidence of hyperdense sign appropriate to clinical deficits.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be assigned to the control or experimental group using a 1:1 computer-generated randomized dynamic allocation procedure. All members of the research team will be blinded to group allocation. Participants and allied health team members (physiotherapist, occupational therapist, nursing) will not be blinded but will be asked not to tell the assessor or other participants which group they have been allocated to, in order to preserve blinding of the assessments. The study statistician and the rest of the Data Safety Monitoring Board will have access to the assignment if necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 8, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)