MedicalResearch.com Interview with:
Caterina Breitenstein, PhD
Department of General Neurology, University of Muenster, Germany
Annette Baumgärtner, PhD
Faculty of Health and Social Sciences, Fresenius University of Applied Sciences, Hamburg, Germany
MedicalResearch.com : What is the background for this study? What are the main findings?
Response: For a long time, it has been assumed that language recovery is limited to the first months after the initial stroke. During the past two decades, however, several clinical studies and systematic reviews have challenged this dogma by demonstrating functional gains in stroke survivors during the chronic post-stroke stage (at least 6 months post the initial stroke) whenever speech and language therapy (SLT) intensity was sufficiently high (i.e., at least 5 h/week for several weeks). These studies, however, lacked the methodological quality required for evidence-based interventions (for criteria, please refer to http://www.cebm.net/ocebm-levels-of-evidence). Until now, this lack in evidence severely hampers stroke survivors’ access to language rehabilitation services .
The present multicenter randomized controlled healthcare trial FCET2EC (acronym stands for “From Controlled Experimental Trial to=2 Everyday Communication) is the first study worldwide to compare three weeks of intensive SLT provided under routine clinical conditions to an equally long period of no (or low intensity) SLT. After 3 weeks of intensive individualized therapy, the 156 stroke survivors with chronic aphasia verbally expressed themselves more effectively in daily-life communicative situations, like changing a doctor’s appointment by a telephone call. Additionally, patients and their significant other rated their communication-related quality of life as significantly improved.
Last but not least, therapy effects remained stable over a follow-up period of six months after the intensive intervention.
MedicalResearch.com : What should readers take away from your report?
Response: Speech and language therapy (SLT) for stroke survivors with chronic aphasia is effective when administered with sufficient treatment intensity (at least 10 h /week in the FCET2EC trial). No or low intensity language therapy (during the waiting and follow-up periods) had no effect on language performance, but low intensity SLT after the intensive intervention period may promote long-term stability of the intensive treatment effects. No participant dropped out during the intensive intervention phase, and the treatment gains were not influenced by any of the examined patient-, stroke-, aphasia-, or treatment-related variables. Thus, intensive speech and language therapy is feasible for the whole group of stroke survivors with chronic aphasia aged 70 or younger (the upper age limit was one of the study’s inclusion criteria to limit possible effects of age-related neurodegenerative cognitive dysfunctions in the older stroke population). This finding clearly demonstrates that intensive practice is the key towards successful aphasia rehabilitation in chronic post-stroke aphasia, and calls for an urgent change in the way rehabilitation resources are currently used in this population.
MedicalResearch.com : What recommendations do you have for future research as a result of this study?
Response: FCET2EC served to demonstrate for the first time world-wide the general effectiveness of intensive SLT in stroke survivors with persistent language impairments. Several questions were beyond the scope of the study and require future research:
What is the minimum treatment intensity required to achieve comparable effects? Can cumulative treatment effects be achieved with repeated intensive SLT intervals? Do stroke survivors older than 70 years or those in the first six months after their initial stroke benefit to a similar degree from intensive SLT? Is the observed treatment effect specific to the agreed-best-practice language intervention applied in the current study?
Are there other factors predicting treatment success not examined in the present trial, such as localization and extent of the underlying brain lesion (which might require samples even larger than the one recruited in the present study)?
MedicalResearch.com : Is there anything else you would like to add? Any disclosures?
Response: Our findings parallel those in other rehabilitation domains (such as physiotherapy) in showing that impairments in language and verbal communication improve with intensive (but not with low intensity) therapy even in the chronic phase post-stroke. Factors like age, time since stroke onset, or aphasia type or severity per se do not prevent positive treatment outcome.
We would like to thank the entire FCET2EC study group including the Trial Steering Committee, the study assessors, the blinded ‘endpoint committee”, and the internal and external data monitors for the passionate support during all phases of the trial.
We have no conflicts of interest to disclose.
Lancet. 2017 Feb 27. pii: S0140-6736(17)30067-3. doi:
10.1016/S0140-6736(17)30067-3. [Epub ahead of print]
Intensive speech and language therapy in patients with chronic aphasia after
stroke: a randomised, open-label, blinded-endpoint, controlled trial in a
Breitenstein C(1), Grewe T(2), Flöel A(3), Ziegler W(4), Springer L(5), Martus
P(6), Huber W(5), Willmes K(7), Ringelstein EB(8), Haeusler KG(9), Abel S(10),
Glindemann R(11), Domahs F(12), Regenbrecht F(13), Schlenck KJ(14), Thomas M(8),
Obrig H(13), de Langen E(15), Rocker R(8), Wigbers F(8), Rühmkorf C(8), Hempen
I(8), List J(16), Baumgaertner A(2); FCET2EC study group.
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