ARTICLE IN BRIEF
INTENSIVE UPPER MOBILITY TRAINING for stroke was conducted for 30 one-hour sessions over a 10-week period.
Researchers found that a structured, task-oriented rehabilitation program for patients with motor stroke and primarily moderate upper extremity impairment did not significantly improve motor function or recovery, compared with either an equivalent or lower dose of usual and customary occupational therapy.
A new study testing the benefits of a task-oriented rehabilitation program to strengthen hand and arm weakness on the heels of a stroke challenges the idea that more training is more effective.
Patients who received intensive upper body training — 30 one-hour sessions over a 10-week period — fared no better than individuals who received a more standard type of rehabilitation and those who received significantly fewer hours, according to a study published in the February 9 issue of the Journal of the American Medical Association.
DR. CAROLEE J. WINSTEIN: “What is important is getting strength back and doing things with the affected hand in the context of their lives. Ultimately, these types of things may be more important than measures of the speed of arm movements. We may not be capturing the integration of that function into someones everyday life. It will take a paradigm shift in deciding what are the most important outcomes to study.”
In the past 10 years, several large studies have tested whether a program that is more challenging (in the tasks and the length of rehabilitation) is more beneficial than standard outpatient rehabilitation. The results have been mixed.
STUDY METHODOLOGY, FINDINGS
Scientists at the University of Southern California in Los Angeles led the Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) study, recruiting 361 stroke patients from seven hospitals around the country. Only patients with upper-body motor impairments following a mild-to-moderate stroke (with NIH Stroke Scale scores of around 3.6) were entered into the study. The patients were randomly assigned to receive either 30 hours of one-hour intensive patient-centered rehabilitation — a structured, task-oriented extremity training program, or Accelerated Skill Acquisition Program (ASAP) — three times a week for 10-weeks; dose-equivalent usual and customary occupational therapy (DEUCC); or monitored usual and customary occupational therapy (UCC) at more or less than 30 hours a week.
Carolee J. Winstein, PhD, a professor of biokinesiology and physical therapy and director of the motor behavior and neuro-rehabilitation laboratory, and a co-principal investigator of the study, said that the research team needed a high enough dose to measure a difference in outcomes. The rehabilitation began about 45 days after the initial stroke. They assessed people at six months and then again at one year.
The primary endpoint was a change in motor function at one year that was assessed using the Wolf Motor Function Test (WMFT). Eighty-four percent of the study participants (304 patients) completed the 12-month assessment. They also assessed secondary outcomes, including the activity and reintegration of their hand into their normal routines and their perception of how they are faring in their lives. These outcomes, which were not included in the JAMA article, were designed to assess whether the patients were using their arm in a meaningful way in their everyday tasks at home. The results are slated for a separate publication.
The researchers were hoping to see a significant difference in the primary outcome — motor performance — in those who received the intensive patient-centered rehabilitation, but they did not. The differences in the WMFT changes between groups at the end of the study were small: for ASAP vs. DEUCC, the mean difference was 0.14 (95% CI, 0.05 to 0.33; p=.16); for ASAP vs. UCC, the difference was -0.01 (95% CI, -0.22-0.21; p=.94); and for DEUCC vs. UCC, it was -0.14 (95% CI, -0.32 to 0.05; p=.15).
At the end of a year, patients in all the study arms, even those who received an average of 11 hours of usual occupational therapy, improved.
The study counters other recent research that has suggested that more time spent on task-oriented upper extremity training is better for stroke patients than conventional physical and occupational therapy. The researchers acknowledged that changing practices among physical and occupational therapists could have accounted for the similar motor outcome measures identified in the study. Also, the broad range (zero to 46 hours) in the hours of rehabilitation that patients received in the control arm of the study may have obscured differences, they said.
Still, the researchers concluded: “The findings from this study provide important new guidance to clinicians who must choose the best treatment for patients with stroke. The results suggest that usual and customary community-based therapy, provided during the typical outpatient rehabilitation time window by licensed therapists, improves upper extremity motor function and that more than doubling the dose of therapy does not lead to meaningful differences in motor outcomes.”
They pointed out that this finding should not be generalized to other stroke-related problems, including walking and quality-of-life measures. The findings may also reflect the timing of the delivery of rehabilitation. Some of the recent studies conducted on such intensive rehabilitation resulted in negative findings when conducted during the acute stroke phase (while still in the hospital), and there were more positive findings when the rehabilitation was conducted during later post-stroke time periods.
“What is important is getting strength back and doing things with the affected hand in the context of their lives,” said Dr. Winstein. “Ultimately, these types of things may be more important than measures of the speed of arm movements. We may not be capturing the integration of that function into someone's everyday life. It will take a paradigm shift in deciding what are the most important outcomes to study.”
“The good news about these findings is that the current standard of care is unsurpassed for now,” said another study author, Alexander Dromerick, MD, vice president for research at MedStar National Rehabilitation Hospital in Washington, DC, and professor of rehabilitative medicine and neurology and chair of rehabilitative medicine at Georgetown University Medical Center. But he added that “our measures may not be telling the whole story of what patients see, experience, and value” in their recovery.
Finally, Steven L. Wolf, PhD, another study author and a professor of rehabilitative medicine at Emory University School of Medicine, stressed that it is important to keep in mind that the patients selected for ICARE represent fewer than 30 percent of stroke survivors. He added that one of the strengths of the training is that it is designed to strengthen problem-solving that in turn improves capacity, motivation, and skill. “Everything is done as a question,” he explained. “For example, the rehabilitation profession may ask: ‘What do you think you could do to move your arm closer to the object?’ We believe that problem-solving spills over to other tasks.”
DR. STEVEN L. WOLF said that one of the strengths of the training is that it is designed to strengthen problem-solving that in turn improves capacity, motivation, and skill. “Everything is done as a question. For example, the rehabilitation profession may ask: ‘What do you think you could do to move your arm closer to the object?’ We believe that problem-solving spills over to other tasks.”
EXPERTS COMMENT
Stroke experts who are involved in testing new interventions told Neurology Today that the study design itself may have led to the findings. Bruce H. Dobkin, MD, FAAN, director of the University of California, Los Angeles (UCLA) neurological rehabilitation and research program and co-director of UCLA's stroke program, said that the “three interventions may not have had enough contrast between them, so all may have engaged the neural networks for motor control in a similar fashion.”
Also, he said that it is impossible to know what patients are doing at home during the study; some may not practice at all and others may practice in a way that increases the effect or works against the formal training.
“The common mantra for early rehabilitation is that a high enough dose of progressive task-related practice will lead to increases in adaptability within neural networks for a particular skill and will lead to better outcomes,” he added. “None of the upper extremity trials in this field include a way to monitor whether participants have attained a plateau in their gains at the end of the planned sessions. There are also limitations to how much improvement may occur, based on factors such as residual neural substrate for the practiced action and motivation to self-manage practice.”
To answer some of the questions, Dr. Dobkin has been pushing for use of wearable activity pattern-recognition sensors to record the type, quantity, and quality of practice and activity outside of the formal rehabilitation setting. The data can provide feedback for goal-setting, train self-management, determine when a plateau is occurring, and offer daily, real-world outcome measurements.
Steven C. Cramer, MD, clinical director of the Sue and Bill Gross Stem Cell Research Center, and professor of neurology, anatomy and neurobiology, and physical medicine & rehabilitation at University of California, Irvine, agrees. “When you are looking at the intervention a person gets in 11 hours or 30 hours, it is a fraction of their lives. It may also be quite important to measure what people do outside of their therapy.”
“Nobody should walk away thinking that it doesn't matter how much or what type of rehabilitative therapy a person gets. That would be a very narrow interpretation,” said Dr. Cramer. “These results do not generalize to the larger stroke population.”
Julie Bernhardt, PhD, director of the National Health and Medical Research Council Center of Research Excellence Stroke Rehabilitation and Brain Recovery at the Florey Institute of Neuroscience and Mental Health in Australia, agreed, adding: “We don't understand the biology of recovery enough, nor do we understand the threshold of treatment that might tip a stroke survivor into a new recovery trajectory, or even if that is possible.”
EXPERTS: ON INTENSIVE TASK-ORIENTED REHABILITATION VS. CONVENTIONAL OCCUPATIONAL THERAPY FOR STROKE RECOVERY
DR. BRUCE H. DOBKIN said that the “three interventions may not have had enough contrast between them, so all may have engaged the neural networks for motor control in a similar fashion.” Also, he said that it is impossible to know what patients are doing at home during the study; some may not practice at all and others may practice in a way that increases the effect or works against the formal training.
DR. STEVEN C. CRAMER: “Nobody should walk away thinking that it doesnt matter how much or what type of rehabilitative therapy a person gets. That would be a very narrow interpretation. These results do not generalize to the larger stroke population.”
DR. JULIE BERNHARDT: “We dont understand the biology of recovery enough, nor do we understand the threshold of treatment that might tip a stroke survivor into a new recovery trajectory, or even if that is possible.”
