ARTICLE IN BRIEF
Researchers reported that intensive speech and language therapy after stroke was more effective than delaying treatment for three weeks.
Three weeks of intensive speech and language therapy notably improved verbal communication in patients aged 70 years or younger with chronic aphasia after stroke, compared with a three-week treatment deferral period for the control group, a new study found.
These findings support an effective evidence-based therapeutic approach in this population of stroke survivors, wrote the authors of the randomized, open-label, blinded-endpoint, controlled trial detailed in the April 15 issue of The Lancet.
“The therapists reported that patients were really thrilled about noticing their progression,” the study's lead author, Caterina Breitenstein, PhD, a cognitive neuroscientist at the University of Muenster in Muenster, Germany, told Neurology Today. “Many were very hopeless when they started. All of a sudden now, there was hope for them.”
Defined as lingering longer than six months after stroke, chronic aphasia affects about 20 percent of all patients who have suffered a stroke, the study authors noted, foretelling the degree of necessary rehabilitation services and the likelihood that an individual will be unable to resume work.
Survival rates after initial stroke are rising, and aphasia accounts for approximately 8.5 percent of stroke-related health-care costs during the first year after stroke, they wrote.
Although results of meta-analyses have concluded that speech and language therapy after stroke is effective even in the chronic stage, if administered with adequate intensity (five to 10 hours per week), the investigators pointed out that the few high-quality studies had either small sample sizes, no untreated or low-intensity therapy control group, or low treatment intensity (less than five hours per week).
Dr. Breitenstein and other investigators in the multicenter trial recommended that future researchers explore the lowest treatment intensity needed for meaningful responses and assess whether the treatment effects accrue over repeated intervention periods.
From April 2012 through May 2014, the researchers randomly assigned 158 patients to the intervention or control group. The modified intention-to-treat population consisted of 156 patients (78 per group).
Dr. Breitenstein said that the age limit of 70 years was motivated by the methodological need to control for the effects of comorbid age-related neurodegenerative diseases affecting cognition. She said patients older than 70 are rarely treated in German rehabilitation centers because health insurance and retirement funds refuse to fund aphasia therapy in the older stroke population.
Participants were recruited from 19 inpatient or outpatient rehabilitation centers in Germany and were randomly assigned to either three weeks or more of intensive speech and language therapy (more than 10 hours per week) or three weeks deferral of intensive speech and language therapy.
Dr. Breitenstein noted that half of the sample received inpatient rehabilitation while the other half received outpatient rehabilitation, and their transportation costs were covered by their health insurance (if they were unable to drive or use public transportation).
The primary endpoint was a between-group difference in the change in verbal communication effectiveness in everyday life scenarios using the Amsterdam–Nijmegen Everyday Language Test A-scale (ANELT-A) from baseline to immediately after three weeks of treatment or treatment deferral. [ANELT-A is designed to assess the level of verbal communicative abilities of individuals with aphasia, and to estimate a change in those communication skills over time.]
All analyses were done using the modified intention-to-treat population (those who received one day or more of intensive treatment or treatment deferral).
From baseline to after intensive speech and language treatment, verbal communication improved by a mean difference of 2.61 points ([SD 4.94]; 95% CI 1.49 to 3.72), but not from baseline to after treatment deferral (–0.03 points [4.04]; –0.94 to 0.88); the between group difference was 0.8 (p=0.0004).
Eight patients incurred adverse events during therapy or treatment deferral, but they were unrelated to the study or treatment.
A sub-sample of 34 patients underwent five weeks or more of intensive speech and language therapy and had mean increases of more than four points from baseline to after therapy. Their improvements indicate that prolonged intensive treatment or repeated periods of therapy in the chronic stage after stroke could lead to more significant effects than those observed in the spontaneous recovery phase early after stroke, the study authors said.
Several neurologists interviewed by Neurology Today concurred that the results may be statistically significant due to the large sample of patients, but they questioned whether they would be clinically meaningful and relevant, particularly for older stroke patients and for those with more severe neurocognitive impairments.
The mean age of patients — 53.5 years in the intervention group and 52.9 years in the control group — was considerably younger than the majority of stroke patients at onset in the United States, they said.
The brains of younger stroke patients are likely to have more neuroplasticity, and that could have contributed to the positive difference observed in the intervention group, as did the exclusion of patients with the absolute worst aphasia, said Steven C. Cramer, MD, a professor in the departments of neurology, anatomy and neurobiology, and physical medicine and rehabilitation at the University of California, Irvine. “For older subjects or those with the most severe deficits, we don't have the data yet,” said Dr. Cramer, who is also clinical director of the university's Sue and Bill Gross Stem Cell Research Center. “More studies are needed.”
That said, the findings were promising, several stroke specialists said. “Although the magnitude of the effect is relatively modest, this is an important study in that it shows, for the first time, a randomized clinical trial effect of aphasia therapy — something that has been lacking in the literature,” said Randolph S. Marshall, MD, FAAN, the Elisabeth K. Harris Professor of Neurology and chief of the stroke division at Columbia Presbyterian Medical Center in New York. “There have been a lot of studies of aphasia treatment, but they have tended to be of case series and descriptions rather than a randomized clinical trial,” he told Neurology Today.
Ronald M. Lazar, PhD, FAHA, FAAN, a neuropsychologist who is professor of neurology and director of the Evelyn F. McKnight Brain Institute at the University of Alabama at Birmingham, said he was impressed that the investigators were able to recruit patients who participated throughout the trial's duration. “The fact that they got virtually complete follow-up is almost unheard of in any clinical trial,” he said. “There are always dropouts.”
Patients were carefully selected using rigid criteria, he noted, with the investigators eliminating potential subjects who would have experienced difficulties in completing the trial. “It raises [questions about] how representative this post-stroke population is of all patients. In ways, it was not so representative.”
On the other hand, cherry-picking a very selective population is a reasonable approach to devising a stroke study, Dr. Cramer said. “The size and locations of strokes are very variable. You have to narrow down that variability.”
“Many variables affect recovery and one of them may be the health of the remaining brain and lesion size,” said Argye Elizabeth Hillis, MD, professor and vice chair of neurology and director of the cerebrovascular division at Johns Hopkins University School of Medicine. “Even medications may influence whether someone recovered or not.”
In addition, the subjects' motivation to participate in intensive speech and language therapy several days per week suggests the existence of a very strong support system to help transport or accompany them back and forth from appointments, Dr. Lazar said. This raises the issue of “how the support systems interacted with the individuals during the course of the trial,” Dr. Lazar said. “Did they reinforce the practice?”
Dr. Lazar said that the study left unanswered whether intensive therapy enabled patients to perform very specific basic activities of daily living on their own, such as ordering a meal in a restaurant or executing a transaction in a bank. This information could have been obtained from a questionnaire administered to patients or their caregivers, he said.
Lack of access to transportation for multiple therapy sessions per week may pose hurdles for some patients who could benefit from intensive speech and language therapy. Furthermore, insurers in the United States are often reluctant to reimburse for such recurrent interventions, said Dr. Hillis, who also trained as a speech-language pathologist.
Dr. Marshall agreed. He noted that generally insurance in the United States will cover a more limited aphasia therapy, often two to three times per week, which is a lower level of intensity than the five days a week offered in the current study. “A clinical trial like this could influence the payment system for rehabilitation, in general,” he said.
He added: “One of the most important things is that this study is consistent with other studies in stroke rehabilitation suggesting that the intensity of therapy and degree of rehabilitation therapy is important, and this is likely due to the principle of neuroplasticity where the brain reorganizes after injury. We call it ‘activity-dependent neuroplasticity.’ We see the neuroplasticity occur at all ages, but it may have been that the younger people would tolerate the longer sessions more than older people.”
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© 2017 American Academy of Neurology
•. Breitenstein C, Grewe T, Flöel A., et alfor the FCET2EC Study Group. 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 http://http://www.thelancet.com
2017; 389: 1528–1538.
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