Rehabilitation Timing for Stroke
(PRESERVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the best time to start rehabilitation therapy after a stroke. Researchers are examining whether beginning physical therapy on or after the third day from stroke onset improves recovery for individuals with blocked arteries in the brain. The trial compares delayed mobilization (DeM, starting therapy on or after day 3) with standard care (starting therapy within 48 hours). It is suitable for those who have recently experienced an ischemic stroke, still have blocked arteries, and face significant neurological issues. The goal is to enhance recovery and reduce long-term disabilities. As an unphased trial, it offers participants the chance to contribute to important research that could improve stroke recovery strategies for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this rehabilitation timing protocol is safe for stroke patients?
Research has shown that starting rehabilitation too soon after a stroke might not always be safe. Some studies have indicated that beginning physical therapy within 24 hours can lead to worse outcomes, including higher chances of death and dependency. This suggests that starting therapy too early might be harmful for some stroke patients.
Conversely, waiting three days or more to start physical therapy is under study for its potential benefits. The idea is to allow the brain some time to settle before beginning active therapy. This approach can be especially important for patients with large strokes or ongoing blood vessel blockages. While more research is needed, waiting a bit longer to start therapy might help improve recovery and reduce the risk of further harm.
These findings suggest that waiting to start therapy, known as delayed mobilization (DeM), might be a safer option for some stroke survivors, offering a better balance between risk and recovery.12345Why are researchers excited about this trial?
Researchers are excited about the trial for delayed mobilization (DeM) after a stroke because it challenges the traditional approach of starting rehabilitation promptly. Unlike standard care, which begins therapy within 48 hours of a stroke, DeM involves waiting at least three days. This delay might offer insights into optimizing recovery by potentially reducing stress on the body soon after a stroke, allowing for tailored rehabilitation when the patient is more stable. Understanding the timing could lead to improved strategies for stroke recovery, focusing on patient-specific needs rather than a one-size-fits-all approach.
What evidence suggests that delayed mobilization is effective for stroke rehabilitation?
Research has shown mixed results about when to start rehabilitation after a stroke. Some studies suggest that moving within 24 hours might not improve recovery or survival rates. In fact, starting physical activity too soon could worsen outcomes or increase dependency. In this trial, one group will receive Delayed Mobilization (DeM), where active therapy begins on or after day 3 from stroke symptom onset. This approach is based on studies suggesting that waiting until day 3 or later to begin rehabilitation could be better, especially for those with ongoing artery blockages. This delay might help reduce further brain damage and improve recovery. Overall, the timing of rehabilitation is crucial, and waiting a bit longer could lead to better long-term results for some stroke survivors.12567
Are You a Good Fit for This Trial?
This trial is for stroke survivors, specifically those with acute ischemic stroke and persistent vessel occlusion. Participants should start physical therapy on or after day 3 from symptom onset to see if delayed mobilization improves recovery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either delayed mobilization starting on or after day 3 post-stroke or standard care with therapy initiation by day 2 post-stroke.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 7 days and 3 months post-stroke.
What Are the Treatments Tested in This Trial?
Interventions
- Delayed mobilization (DeM)
Trial Overview
The study compares standard care with delayed mobilization (physical therapy starting on or after day 3) in stroke patients. It aims to determine the best time to begin rehabilitation for better functional outcomes and reduced brain harm.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Active therapy beginning ≥3 days from stroke symptom onset.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Citations
Very early versus delayed mobilisation after stroke - PMC
VEM, which usually involved first mobilisation within 24 hours of stroke onset, did not increase the number of people who survived or made a good recovery after ...
Outcome After Mobilization Within 24 Hours of Acute Stroke
We identified a trend toward increased poor outcome, death rate, and dependency among patients mobilized within 24 hours after hospitalization.
A systematic review and meta-analysis of clinical efficacy of ...
The results showed that early rehabilitation training was more effective than late rehabilitation to improve motor function in patients with ...
Efficacy of very early mobilization in patients with acute stroke
An early mobilization protocol successfully delivers more and earlier therapy to acute stroke patients: further results from phase II of AVERT. Neurorehabil ...
High Intensity Physical Rehabilitation Later Than 24 h Post ...
At 3 month follow up, 53.5%, (n = 46) of patients with Early Intensive Mobilization showed a favorable outcome (modified Rankin Scale 0–2) (p = ...
Efficacy and safety of very early rehabilitation for acute ...
This meta-analysis proved that VER could elevate the risk of death after stroke and stroke severity during hospitalization. However, it significantly lowered ...
Impact of Early Out-of-Bed Mobilization on Functional ...
The delay between bleeding and OOB mobilization is an independent risk factor for reduced functional independence and CVS occurrence.
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