Whilst hyper acute stroke care has been revolutionised by the development of blood clot busting medications and clot removal techniques, for those who are unsuitable for these treatments and require rehabilitation (approximately 70% people) the best interventions to promote recovery are yet to be discovered.
Ground-breaking international stroke rehabilitation trials such as AVERT (1), where the impact of early mobility on disability was explored in over 2000 stroke survivors, appear to lead to more questions than answers. Early pilot work indicated that a very early mobility intervention would improve outcome after stroke (measured by the modified Rankin Scale) and was cost effective (2-4). The AVERT trial demonstrated however that early mobility training could actually interfere with recovery and cause harm compared to usual care.
I am just returning from the World Stroke Congress (2018) in Montreal and more surprising results came from another large recovery trial: VERSE (5). Results in chronic stroke patients demonstrate intensive therapy for aphasia can improve speech and language and pilot work indicated this may also be true for early intensive aphasia interventions (6). But the results of the VERSE study revealed that although feasible and not harmful with the case of this early intervention again ‘more was not better’.
As when the results of the AVERT trial were announced at ESOC (2016) in Glasgow, when the results of VERSE were announced a pin could be heard drop in the auditorium. Although some would class these results as ‘negative’ one could argue they were anything but for two key reasons. Firstly, these trials answered important clinical questions, albeit not with the answers they expected. Secondly, both trials managed to successfully tackle the ‘beast’ that is rehabilitation research with success and rigour. One of the problems often encountered in rehabilitation research is poor description of what elements go into interventions…what ingredients go into the ‘black box’ that is therapy. Trials such as AVERT and VERSE had clear intervention descriptions with VERSE using the Template for intervention description and replication (TIDieR) (7) to describe content. VERSE also made efforts to capture whether the intervention was delivered as intended i.e. fidelity. We can only start to determine the efficacy of different rehabilitation interventions if we know they are delivered as intended and start to measure this using frameworks such as the one proposed by Bellg (8).
One of the key messages that abounded at the WSC for recovery research was to move the field forward we need to start unpicking what is ‘just the right amount’ for each stroke survivor. Secondary analysis of AVERT indicated that although the overall outcome for early mobility was negative, individual groups may have different responses to the intervention. For those with a bleed in the brain or severe disability early mobility may have been ‘too much’ whereas for those with mild impairment it may have been ‘too little’. This is what is referred to as the goldilocks principle…..goldilocks tried three different bowls of porridge to find the one that was just right for her.
The clear message from the WSC was that in order to develop recovery research and to discover what is ‘just right’ for stroke survivors we need to develop large trials with rigorous protocols that ask the right questions and measure the right outcomes. The good news is we appear to be moving into a new era for recovery research. Guidelines for stroke recovery and rehabilitation research (SRRR) were developed at the World Stroke Congress 2016 in Hyderabad (9,10). These guidelines will be further be developed following the second roundtable event held straight after the WSC in Montreal. This consensus gathering exercise with experts from around the world is vital for the progression of the rehabilitation and recovery field in stroke.
Using these guidelines international trials would enable the large sample sizes required to answer many recovery questions and bring momentum and advancement to this complex field. Fostering future collaboration in early career researchers is imperative to drive the field forward. I was privileged to be invited to Global Alliance of Independent Networks focused on Stroke trials (GAINS) meeting for early career investigators from around the world held prior to WSC 2018. This meeting provided a chance to gain useful feedback on early project designs and discussion on potential avenues for collaboration and career progression.
So final thoughts from WSC 2018….
..To progress the field of rehabilitation research it appears we may need to pick the right person and right time for each intervention
..Guidelines and international collaboration to develop rigorous protocols appear to be the way forward to start to answer the goldilocks principle for rehabilitation research.
…Defining what goes into the black box of rehabilitation research will help to unpick the most effective interventions
…And if the crowds of people overflowing out of the rehabilitation sessions at WSC 2018 is anything to go by watch this space for the rehabilitation and recovery research revolution…….!!!
1.The AVERT Trial Collaboration Group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. The Lancet. 2015;386(9988):46-55.
- Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G. A Very Early Rehabilitation Trial for stroke (AVERT): phase II safety and feasibility. Stroke 2008; 39: 390–96.
- Cumming T, Thrift A, Collier J, et al. Very early mobilisation after stroke fast tracks return to walking: further results from the phase II AVERT randomized controlled trial. Stroke 2011; 42: 153–58.
- Tay-Teo K, Moodie M, Bernhardt J, et al. Economic evaluation alongside a Phase II, multi-centre, randomised controlled trial of very early rehabilitation after stroke (AVERT). Cerebrovasc Dis 2008; 26: 475–81.
- E. Godecke, E. Armstrong, T. Rai, S. Middleton, N. Ciccone, M. Rose, A. Holland, A. Whitworth, F. Ellery, G. Hankey, D. Cadilhac, J. Bernhardt. Very early rehabilitation in speech (VERSE): A prospective, multicentre randmised controlled open-label, blinded-endpoint trail in patients with aphasai following acute stroke. (2018) Presented at world Stroke Congress, Montreal 2018
- Breitenstein C, Grewe T, Flöel A, Ziegler W, Springer L, Martus P, et al. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting. The Lancet. 2017;389(10078):1528-38.
- Glasziou; H, Milne; B, Altman; PM, Macdonald; B, Lamb; J, Dixon-Woods;, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014(348):1687-.
- Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychology. 2004;23(5):443.
- Bernhardt J, Borschmann K, Boyd L ea. Moving rehabilitation research forward: developing consensus statements for rehabilitation and recovery research. . Int J Stroke. 2016;11:454-8.
- Kwakkel G, Lannin NA, Borschmann K, English C, Ali M, Churilov L, et al. Standardized Measurement of Sensorimotor Recovery in Stroke Trials: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable. Neurorehabilitation and Neural Repair. 2017;31(9):784-92.