Background and Purpose-Of all stroke survivors, 30% to 66% are unable to use their affected arm in performing activities of daily living. Although forced use therapy appears to improve arm function in chronic stroke patients, there is no conclusive evidence. This study evaluates the effectiveness of forced use therapy. Methods-In an observer-blinded randomized clinical trial, 66 chronic stroke patients were allocated to either forced use therapy (immobilization of the unaffected arm combined with intensive training) or a reference therapy of equally intensive bimanual training, based on Neuro-Developmental Treatment, for a period of 2 weeks. Outcomes were evaluated on the basis of the Rehabilitation Activities Profile (activities), the Action Research Arm (ARA) test (dexterity), the upper extremity section of the Fugl-Meyer Assessment scale, the Motor Activity Log (MAL), and a Problem Score. The minimal clinically important difference (MCID) was determined at the onset of the study. Results-One week after the last treatment session, a significant difference in effectiveness in favor of the forced use group compared with the bimanual group (corrected for baseline differences) was found for the ARA score (3.0 points; 95% CI, 1.3 to 4.8; MCID, 5.7 points) and the MAL amount of use score (0.52 points; 95% CI, 0.11 to 0.93; MCID, 0.50). The other parameters revealed no significant differential effects. One-year follow-up effects were observed only for the ARA. The differences in treatment effect for the ARA and the MAL amount of use scores were clinically relevant for patients with sensory disorders and hemineglect, respectively. Conclusions-The present study showed a small but lasting effect of forced use therapy on the dexterity of the affected arm (ARA) and a temporary clinically relevant effect on the amount of use of the affected arm during activities of daily living (MAL amount of use). The effect of forced use therapy was clinically relevant in the subgroups of patients with sensory disorders and hemineglect, respectively.

Kunkel and colleagues 1 recently published an article on constraint-induced (CI) movement therapy for motor recovery in chronic stroke patients. They presented the results of an uncontrolled series of 5 stroke patients undergoing CI therapy. The authors also presented a review of five studies, including their own, concerning the effectiveness of CI therapy based on a calculation of effect sizes. We have several concerns with this paper.In our opinion, research in physical medicine and rehabilitation has progressed to a point at which patient series no longer make any substantial contribution to the accumulation of knowledge. Controlled studies, preferably randomized, are needed to determine the effectiveness of treatment modalities. Uncontrolled studies can be misleading and will almost always report grossly overestimated treatment effects.2 The importance of a control group, when evaluating CI therapy, is emphasized by the interim conclusions of a controlled study carried out by Wittenberg and colleagues, 3 who found that patients who received standard therapy also showed improvement, possibly due to expectation bias. The results of a randomized clinical trial conducted at our hospital, which will be published shortly, confirm this. 4In their literature review, Kunkel and colleagues claim to have identified two controlled studies. However, the publication on one of these studies mentions a control group of 15 patients, but provides no data concerning improvement in either the experimental or the control group) Therefore, we were puzzled by the fact that Kunkel presented data on the experimental group of 20 patients in this study, but no data on the control group.Finally, we strongly disagree with the interpretation of effect sizes based on trends over time in uncontrolled series as important evidence in favor of CI movement therapy. In fact, when using within-group time trends to calculate effect sizes, all the methodologic advantages of having a control group are ignored. We conclude that Kunkel failed to demonstrate that CI therapy is efficacious for chronic stroke patients. Johanna H. van der The authors replyVan der Lee and colleagues are correct in emphasizing that randomized controlled studies are preferable to uncontrolled studies; however, replications of clinical series still have a place in rehabilitation research. As noted in our report, we sought to perform an independent replication of the effects of constraintinduced movement therapy, which had only been fully tested in coauthor Taub's laboratory. ~,2 A similar replication without a control group appeared recently in Stroke. 3 Since CI treatment is a new and promising therapy, we believe that these independent replications are still viable, as was also suggested by Ottenbacher. 4 The paper by Wittenbacher and associates 5 is a preliminary report with still-unpublished data and no conclusions can be drawn from it. The meta-analysis was limited to pre-post effect sizes, since only two of the studies we reported contained a control group. Control g...