Poster The Joint Annual Meeting of the Stroke Society of Australasia (SSA) and Smartstrokes 2023

Can we be more inclusive? Recruitment Barriers to Exercise Trials for Stroke Survivors (#157)

Ashley Park 1 , Emily Dalton 2 , Laura McCambridge 3 , Kate Hayward 1 2 3 , Amy Brodtmann 1 4
  1. Department of Medicine & Neurology , Melbourne Brain Centre, The Royal Melbourne Hospital , Parkville, VIC, Australia
  2. Department of Physiotherapy, University of Melbourne, Parkville, VIC, Australia
  3. Stroke Theme, Florey Institute of Neuroscience and Mental Health , Heidelberg, VIC, Australia
  4. Department of Neurosciences , Central Clinical School, Monash University, Clayton, VIC, Australia

Background: Stroke rehabilitation trials involve heterogenous samples with varying interventions, rendering the results difficult to generalise to the stroke population. Patients with communication and cognitive barriers are often excluded due to perceived participation difficulties in exercise therapies. The challenge of maintaining a balance between equitable representation and targeted research is an ongoing conundrum in trial designs. Strict eligibility criteria can limit generalisability, delay recruitment, and increase health inequities.

Aim: To review the literature and identify key eligibility criteria used in stroke exercise trials that limit recruitment.

Methods: A systematic review of stroke rehabilitation RCTs published 2017-2022 were included from an electronic database search (PUBMED). The inclusion criteria were: 1) randomised controlled trials, 2) ischaemic or haemorrhagic stroke patients, 3) exercise intervention, 4) cognitive outcomes (either primary or secondary) and 5) publication within the last 5 years (to capture pre- and peri-pandemic studies). Included and excluded studies were reported as per PRISMA guidelines. 

Results: Eighty studies were identified with 19 (n=1908) included in the final review. A significant number of trials excluded aphasia (37%), had cognitive restrictions (68%) or mobility limits (58%). The presence of co-morbid conditions such as neurological or psychiatric conditions were also common exclusion criterion (63%). The recruitment rate varied from 2% to 100%, with a mean of 48%. The most common exclusion reason was “does not meet eligibility criteria” (n=4604, 62%) followed by “declined to participate” (n=2242, 30%). Interestingly, 476 (6%) patients were excluded due to convenience reasons (e.g., lived too far away).  

Conclusion: Despite being frequent post-stroke deficits, aphasia and cognitive impairment were common exclusions in stroke recovery exercise trials, limiting the applicability of such therapies in stroke survivors and significantly reducing accessible cohorts. Researchers must expand the inclusivity of their trials to ensure all stroke patients who are presumed to benefit from an intervention are represented.

  1. McGill K, Sackley CM, Godwin J, McGarry J, Brady MC. A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials. Trials. 2020;21(1):68.
  2. Geed S, Feit P, Edwards DF, Dromerick AW. Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits?. Front Neurol. 2021;12:674237.
  3. Dalton EJ, Lannin NA, Campbell BC, Churilov L, Hayward KS. Enhancing generalizability of stroke clinical trial results: Illustrations from upper-limb motor recovery trials. Int J Stroke. 2022;0(0).
  4. Shiggins C, Ryan B, O'Halloran R, et al. Towards the Consistent Inclusion of People With Aphasia in Stroke Research Irrespective of Discipline. Arch Phys Med Rehabil. 2022;103(11):2256-2263.