Post-stroke REhabilitation Start Evaluation for Reducing Vascular Events

NCT07212738 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-08

No results posted yet for this study

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

Interventions

OTHER

Delayed mobilization (DeM)

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

OTHER

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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212738 on ClinicalTrials.gov