High-intensity task-orientated rehabilitation training did not produce better motor outcomes at 1 year than usual care in patients with a motor stroke with moderate impairment, according to the primary results of the Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) study.
Although the primary results may seem disappointing, lead author, Carolee J. Winstein, PhD, University of Southern California, Los Angeles, told Medscape Medical News that data on secondary outcomes look more promising.
"We are only reporting the primary motor outcomes here. We measured other secondary outcomes, too, such as going back to work, quality of life, and perceived capacity to carry out tasks, and we found some improvements. These are other measures of returning to normal living that go beyond motor performance and are very meaningful to patients."
She added: "It's like thinking about rehabilitating an arm attached to a person or rehabilitating a person who has a paretic arm."
"These patients had relatively small strokes (average NIHSS [National Institutes of Health Stroke Scale], 3.6) but they had moderate impairment in their arms," Dr Winstein said. "Our results suggest that specific motor therapy focusing on skills involving the paretic arm may have other nonmotor benefits. This may be because we incorporated many patient-centered strategies, with collaborative agreements with therapist and patient as to which exercises to do.
"In addition, the intervention under study involved a high-intensity workload, and there was a strong reward philosophy acknowledging the patients' achievements."
She concluded that: "On the basis of the current publication of our primary results we can't recommend anything other than usual care for this group of patients, but when our secondary results are reported this may change — so watch this space."
The researchers also collected imaging data. "We have 297 images which is largest database ever from a rehab trial in stroke patients, and they show very interesting results," Dr Winstein notes.
"Rehabilitation trials are a relatively new concept," she added. "We don't know yet what the best endpoints should be in these trials. The secondary outcomes and imaging data, which will be the subject of subsequent papers, will suggest new directions for rehabilitation after stroke."
The study involved 361 patients who were a mean of 46 days post-stroke. They were randomly assigned to three different groups: the high-intensity task-oriented therapy (known as the Accelerated Skill Acquisition Program), which consisted of 30 one-hour sessions over 10 weeks; a dose equivalent of usual therapy; or just usual therapy, whatever that might have been.
Dr Winstein noted that the third option had a large variability, with a range of 0 hours to 46 hours. "The average was 11 hours — less than half the dose of the high-intensity groups — but this achieved the same motor outcomes."
The primary outcome was 12-month change in log-transformed Wolf Motor Function Test (WMFT) time score, consisting of a mean of 15 timed arm movements and hand dexterity tasks).
Secondary outcomes were change in WMFT time score and proportion of patients improving more than 25 points on the Stroke Impact Scale hand function score. No significant differences were found between groups in any of these endpoints.
The researchers write that their 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.
"However, these results cannot be assumed to generalize to other outcomes (eg, health-related quality of life, community participation), other stroke-related impairments such as walking, other stroke populations, or rehabilitation time points earlier or later following stroke than those studied here," the authors write.
They point out that different physiologic and psychological responses to rehabilitation training might occur at different times after stroke onset, raising the possibility that dosing and timing are not independent factors in stroke rehabilitation intervention trials.
They suggest that this observation could explain why trials conducted early after stroke (eg, AVERT and VECTORS) found undesirable effects of more intensive interventions, whereas the EXCITE trial, conducted later after stroke, found a positive effect. ICARE, timed in between, found no dose effect.
They also note that the use of standard care is not an ideal control group because it may have evolved over time to resemble the investigational intervention. They add that this limitation is inherent to pragmatic trial designs; and "for ICARE, both usual therapy groups represented a relatively high standard of outpatient practice."
The ICARE trial was funded jointly by the National Institutes of Health, the National Institute of Neurological Disorders and Stroke (primary), and the National Center for Medical Rehabilitation Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Each author received support from this grant during the conduct of the study. The authors have disclosed no relevant financial relationships.
JAMA. Published February 9, 2016. Abstract
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Cite this: ICARE Published: Usual Care Stroke Rehab Best for Motor Outcomes - Medscape - Feb 11, 2016.