High-Intensity, Repetitive Rehabilitation Improves Function, Quality of Life in Chronic Stroke Patients

Caroline Cassels

March 01, 2010

March 1, 2010 (San Antonio, Texas) — High-intensity, repetitive rehabilitation exercise can result in improved function and quality of life in severely disabled chronic stroke patients years after they have experienced their initial event, new research suggests.

In one of the few randomized clinical stroke rehabilitation trials conducted in the United States, investigators at the Providence Veterans Affairs Medical Center and Brown University in Rhode Island showed that severely affected chronic stroke survivors who had 12 weeks of either robot- or human-assisted therapy experienced clinically significantly improved arm function compared with standard care and better quality of life at 6 months compared with those who had no additional therapy.

"I think this study sends a hopeful message that high-intensity therapy can result in improved motor function and quality of life for a group of patients that is often considered to be beyond treatment," principal investigator Albert Lo, MD, PhD, told Medscape Neurology.

The findings were released here at a late-breaking scientific session at the International Stroke Conference 2010.

Large Therapeutic Gap

According to Dr. Lo, there is a widely held belief among the medical community that little can be done to improve function in stroke patients beyond 1 year of the index event. In addition, he said, clinical trials often focus on treatment in the acute stage of stroke, and as a result, there are few therapeutic options for chronic stroke patients.

Dr. Albert Lo

Furthermore, he said, rehabilitation research has not been held to the same rigorous standard as other potential stroke treatments, including drugs and medical devices.

To address this "large therapeutic gap," Dr. Lo and colleagues conducted a multicenter randomized controlled trial comparing robot therapy (RT), intensive comparison therapy (ICT), and usual care (UC).

Study participants included 127 veterans (median ± SD age, 65 ± 11 years; 96% male) at 4 centers in the United States. All participants had an index stroke at least 6 months before study enrollment, resulting in moderate to severe upper extremity impairment (Fugl-Meyer Assessment [FMA] score of 7 to 38). The time from index stroke ranged from 6 months to 24 years, with an average of 5 years.

"This was a very severe group of patients. In addition to their index stroke, approximately 33% of our participants had had multiple strokes. Further, 20% of individuals had strokes that took up more than one-third of their brain," said Dr. Lo.

Going into the study, the investigators' hypothesis was that RT would be superior to both ICT and UC. The study's primary endpoint was improvement in the FMA upper extremity score at 12 weeks relative to baseline.

Secondary outcomes included the Wolf Motor Function Test (WMFT) and the Stroke Impact Scale (SIS). Participants were evaluated in clinic at 6, 12, 24, and 36 weeks.

Subjects were randomized to receive RT (49), ICT (50), or UC (28). Participants in the active treatment groups underwent 3 one-hour sessions per week for 12 weeks with each RT session including 1000 movements.

The ICT group used a structural conventional rehabilitation protocol that matched the RT group in terms of the number of sessions and type and frequency of movements. UC included customary care after stroke, including antihypertensive and antithrombolytic therapy, as well as voluntary dietary and exercise modifications.

At 12 weeks RT improved by 1 point and UC declined by 1 point, showing a mean difference of 2.17, a result that was not statistically significant (P = .08).

The investigators found a 4-point increase in FMA scores in both the ICT and RT group, with about half a point in favor of ICT. However, no statistical difference was seen between the 2 groups.

Intensity, Not Mode, of Therapy Important

At 36-week follow-up, however, both RT and ICT were significantly superior to UC in improving arm function, with a 3-point improvement on the FMA scale. In addition, patients in these groups experienced significant improvement on the WMFT and the SIS compared with the UC participants at 36 weeks.

It was surprising, said Dr. Lo, that RT was not superior to ICT on any outcome at any time point.

"The message from this study appears to be that it is the intensity of the exercise and perhaps not the mode of delivery that is important in functional recovery in chronic stroke patients," he said.

He added that although the results were modest, the fact that there was any improvement in this group of patients who had experienced severely chronic stroke was reassuring.

The researchers found no treatment-related serious adverse events. Although the RT participants experienced more pain and stiffness, these adverse effects tended to be transient and mild.

The study's retention (96%) and completion rates (median, 36 of 36 sessions attended) were excellent, said Dr. Lo.

Although the study missed its primary endpoint, he said, the results send a hopeful message about recovery in chronic stroke patients. Dr. Lo said his team is conducting secondary analyses to characterize the responders.

In a broader sense, the study also demonstrates that conducting randomized controlled trials in rehabilitation is feasible and valuable, he added.

"We don't have a lot of treatment options for these patients. The latest American Heart Association statistics show there are 6.4 million, and many of them have lasting deficits that are often considered permanent. Our study shows that intensive, repetitive exercise can help improve recovery in this very chronic group and improve their quality of life," said Dr. Lo.

Future research includes a neuroimaging study to investigate the potential impact of intensive rehabilitation therapy on neuroplastic changes in the brain.

Another potential advantage of active rehabilitation treatment in this patient population may be economic. Although at first glance, ICT and RT may appear to be significantly more expensive than UC, preliminary cost analyses suggest that chronic stroke patients who receive active treatment use significantly fewer health resources than their UC counterparts, which offsets the initial costs of care and significantly narrows the cost differential from UC to RT to about $4 per day.

Findings Encouraging

Commenting on the study, Andrei Alexandrov, MD, director, Comprehensive Stroke Center, University of Alabama Hospital in Birmingham, said the findings are exciting and encouraging, although "not a slam dunk."

"This was a relatively small study, but it does suggest that recovery is possible [in chronic stroke patients]. It's not definitive, but we know that the true potential of the brain to recover is not known or appreciated, and this study helps shed some light on this question," Dr. Alexandrov told Medscape Neurology.

The study serves as an excellent example of the way stroke rehabilitation research should be conducted, said Dr. Alexandrov. "Methodology is important, and we need to make sure that rehabilitation, like other [stroke], is evaluated scientifically."

Dr. Lo and Dr. Alexandrov have disclosed no relevant financial relationships.

International Stroke Conference (ISC) 2010: Abstract 196. Presented February 26, 2010.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....