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Comparing two identically protocolized, multicentre, randomized controlled trials on caregiver-mediated exercises

Marijn Mulder^1,2, Rinske H M Nijland², Judith D M Vloothuis²

¹Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam UMC, VU University Medical Centre, Amsterdam, The Netherlands.

|January 25, 2022

Summary

Despite using identical protocols, clinical differences between Dutch and Australian stroke rehabilitation trials were observed. These variations may influence recovery potential and treatment effects, suggesting a need for international collaboration in pragmatic trials.

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Area of Science:

Rehabilitation Medicine
Clinical Trials
Stroke Recovery

Background:

Evidence for post-stroke rehabilitation interventions often lacks robustness.
Variation in treatment effects across different countries is under-researched.

Purpose of the Study:

To compare two identically protocolized trials in different Western countries.
To identify factors contributing to variations in secondary trial outcomes.

Main Methods:

A comparative study of individual patient data (N=129) from two randomized controlled trials in the Netherlands and Australia.
Patients received an 8-week caregiver-mediated exercises intervention or usual care.
Outcomes measured included anxiety, depression, fatigue, and self-efficacy.

Main Results:

Dutch patients were younger with lower functional status; Australian patients were recruited earlier and had less exercise therapy.
Higher contamination was observed in Dutch control groups.
No significant effect modification or change in trial outcomes was found after controlling for cross-country differences.

Conclusions:

Identical study protocols revealed significant clinical differences between countries, potentially impacting recovery and treatment effects.
These findings support the use of international pragmatic trials for faster intervention evaluation.