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Re: mCIT: Are We Putting the Cart Too Far Before the Horse?
mCIT: Are We Putting the Cart Too Far Before the Horse?
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Steve Page, Associate Professor University of Cincinnati Academic Medical Center, Peter Levine
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PAGESJ{at}UCMAIL.UC.EDU Steve Page, et al.
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We appreciate Dr Steven Wolf’s interest in our article. Although we agree with him on some points, several remarks in his letter are at odds with existing evidence, including data published by his own team. Other observations by Wolf do not resonate with the realities of clinical practice.
mCIT: The Whole Is More Than the Sum of Its Parts Wolf correctly observes that modified constraint-induced therapy (mCIT) offers patients substantially more home-based practice opportunities than CIT (about 250 hours versus about 126 hours during the EXCITE trial,1 per Wolf’s estimate). In light of this difference, Wolf speculates that this facet is responsible for the comparatively larger Motor Activity Log (MAL) changes that we reported. We agree that the question of why and how home-based efforts drive recovery deserves greater attention. The limitations of practicing tasks in the clinic (rather than in the patient’s home environment), and trends toward diminishing in-clinic contact time, argue for protocols that place greater emphasis on structured, home-based practice scenarios. Consistently, the mCIT home component features highly structured “homework” sessions occurring for 5 hours/day in patients’ real-world environments. These sessions are a purposeful extension of practice provided in the mCIT clinical sessions. This is a stark contrast to the comparatively unstructured CIT restraint component. The careful structuring of the mCIT home program might influence the comparatively larger MAL outcomes observed after mCIT, as suggested by Wolf. However, there are additional, favorable aspects of the mCIT protocol that also likely conspire to produce comparatively larger outcomes than CIT. These include:
2. Due to learned nonuse, protocols that encourage the patient to independently reintegrate the affected arm in functional tasks are desirable. Whereas CIT places significant emphasis on in-clinic, therapist interaction to engender increased use, 94.7% of the mCIT protocol (per Wolf’s estimate) is home-based, structured practice. In mCIT exit interviews, subjects have consistently reported that these home-based practice situations were critical to inducing them to use their affected arms. The inherent advantages of a therapy that is self-initiated and self-motivated and that allows patients to “drive” their own nervous system in ways that are relevant to their home environment cannot be underestimated. This emphasis that mCIT places on home-based, independent affected arm use also likely has an impact on the comparatively larger MAL scores of subjects using mCIT. 3. Numerous groups have reported that CIT is tiring, with one CIT trial noting that the effort that subjects had to put forth to participate was “strenuous.” 7 Likewise, Wolf’s letter noted that patient fatigue was an important limiting factor affecting participation in CIT clinical sessions. Fatigue is known to affect motor learning and consolidation8; it also is a common clinical tenet that fatigue diminishes other aspects of patient participation (eg, mood, motivation) that influence outcomes. In contrast, because it is self-initiated, the at-home component of mCIT also is self-paced and, therefore, not as fatiguing, according to patient reports. In fact, most note that the sessions are comparable to the outpatient therapy regimens that they have already received. It is likely that markedly less fatigue associated with mCIT participation may mediate a number of patient attributes, and also play a role in mCIT’s comparably better outcomes. In summary, we agree with Dr Wolf that the structure of the mCIT home practice sessions is an intriguing, potentially superior departure from the CIT home practice schedule. However, other scientifically validated mCIT ingredients also contribute to the comparatively larger MAL outcomes associated with mCIT participation. MAL Maladies: A Caution About Wolf’s Caution Dr Wolf also reported that the MAL Amount of Use section might not be reliable,9 suggesting that this MAL scale “should be used with caution.” This could be a potential concern for our study results, because we used this version of the MAL as a measure of affected arm use. However, as in pilot mCIT work leading to the current trial,10 we corroborated MAL amount-of-use findings with activity monitor data. These devices have been shown to provide valid, objective measurements of affected arm use.11 Our activity monitor analyses confirmed that only subjects receiving mCIT showed significant affected arm use changes; they will be reported separately. Given the converging nature of our activity monitor findings and their established track record as a measure of affected arm use, we are confident in our MAL data trends. This finding should address Wolf’s stated concern. We also wish to point out that this “unreliable” version of the MAL was the sole affected-arm–use measure in the principal EXCITE publication.1 This MAL version also has been used in other CIT trials.12 Unlike our study, none of these CIT publications used surrogate measures of affected arm use (eg, activity monitors). Based on Wolf’s concern about suboptimal MAL reliability and in the absence of surrogate affected-arm–use measures in these reports, one could reason that the amount of use findings reported in these CIT studies warrant real caution. Similarly, this version of the MAL was used in a recently published EXCITE follow-up study by Wolf and colleagues.13 This study reported sustained affected-arm–use patterns associated with CIT participation, as measured 24 months after treatment. The validity of conclusions made by such long-term studies hinges on the use of measures with high test-retest reliability. In light of Wolf’s caution about the MAL’s suboptimal reliability, one could reasonably question the validity of conclusions rendered by his own EXCITE follow-up study. It is likely that conclusions based on MAL findings are valid in our study, as well as in Wolf’s above-mentioned efforts. The above shortfalls from EXCITE work illustrate the importance of exercising caution, and garnering more empirical support, before taking Wolf’s remarks to heart. Limitations of CIT: Still There One of Wolf’s most perplexing remarks was his assertion that therapists’ largest CIT concern is its reimbursement. It is almost inconceivable that a practicing therapist’s principal concern with a 6-hour/day therapy would be whether his or her facility gets reimbursed for it. What about the time that therapists have to invest? Patient adherence and “buy in” with such an intensive protocol? Patient fatigue? As noted earlier, Wolf himself concedes that “participants simply did not possess the endurance to train for the entire 6 hours [of CIT].” He also noted that patients in the EXCITE study were able to handle only about 3 hours/day of clinical therapy—a finding confirmed by a recent EXCITE publication.14 Thus, Wolf’s own data suggest that CIT concerns transcend its mere reimbursement. Several groups15 also have raised concerns with the high-duration CIT clinical and home-based components and their practical implementation. For example, our survey of subjects’ and therapists’ opinions about CIT16 found that the majority of patients would not want to participate in CIT, and more than 80% of therapists reported that their facilities could not administer such an intensive protocol. Fatigue, frustration, adherence, reimbursement, and loss of independence were mentioned as concerns by patients and therapists in this survey. Other CIT researchers have cited: (1) poor compliance with unsupervised constraint17; (2) burns, muscle soreness, and discomfort in the affected arm18,19; and (3) pain increase in 4 of the 5 patients in the constraint group.17 These data further suggest that CIT concerns transcend mere reimbursement. Wolf acknowledges that CIT’s components are high in duration. He then attempts to defray this limitation by citing an exit interview among EXCITE participants, in which subjects reported that the high-duration nature of the CIT components was “helpful.” Although interesting, that study has an inherent selection bias, stemming from the fact that subjects who responded that the CIT duration was “helpful” had already been exposed to that intervention. Unless Wolf and his team also told subjects that other, efficacious durations were available, CIT, as administered in EXCITE, would constitute their only frame of reference from which to draw their opinions. Wolf also correctly observes that we have previously included only part of a quote from his 1999 case study.20 He tries to “set the record straight” by including the rest of the passage. In our estimation, the fact that an apparently motivated patient has consented to a CIT study, yet does not adhere to one of its signature parameters, is striking. This is why we have historically not included the remainder of the quote. In summary, Wolf’s arguments regarding CIT limitations contradict existing data, including his own. They also do little to address the fundamental limitations with regard to CIT’s high duration or its practical implementation, as cited by several groups. The fundamental CIT shortfalls remain. Blinding the Therapists and the Subjects to Group Assignment Wolf also questions why we would blind therapists to study hypotheses, citing 2 reasons not to blind therapists: (1) “clinicians’ knowledge about the intent of a study is important for fostering proactive involvement” and (2) “participating clinicians’ inherent intellect and training would allow them to easily deduce the hypotheses.” With regard to point 1, it has been our experience that therapists are excited about the opportunity to learn the literature and techniques surrounding mCIT. As one might expect, neither therapists’ involvement nor their enthusiasm have been diminished by whether they know the specific study hypotheses, as Wolf suggests. With regard to point 2, the main purpose of blinding therapists to study hypotheses was to diminish possible subjective biases or expectations as they administered treatment. Importantly, this technique has been used in clinical trial design for decades. It is certainly possible that study clinicians could form opinions about study hypotheses or anticipated patient group responses; this concern is present in virtually any therapy trial. However, such possibilities should not diminish the impetus to rigorously conduct scientific trials under the most controlled conditions that can be constructed. The same also can be said for subjects: they could certainly gather information about the various therapy groups. From this information, they could then form expectations about their responses to the treatment condition to which they are assigned. In the interest of scientific rigor, we prefer to attempt to control this possibility to the best of our ability by limiting the hypothesis-related information that we provide to them. The Clinical Portion of mCIT Has Been Reimbursed, Using Existing CPT Codes, for Several Years Wolf correctly notes that mCIT does not have its own CPT code. He then suggests ways that our wording could be adjusted to be adequately descriptive of mCIT’s reimbursement. In this spirit, we offer the phrasing used in the heading of this section as a more precise (albeit awkward) semantic alternative. More importantly, Wolf is inaccurate in his claim that each CPT code is “defined for a specific intervention.” This is an important point, because Wolf uses the above argument as one of his bases for his assertion that the CIT intervention needs its own CPT code. As a point of fact, neither specific techniques (eg, proprioceptive neuromuscular facilitation, neurodevelopmental treatment) nor general theoretical approaches to interventions (eg, motor relearning) have their own CPT codes. Instead, various techniques are grouped into a single CPT code according to the larger, common functional goals that the techniques serve. For example, a variety of activities intended to develop strength and endurance, range of motion, and flexibility are covered under the therapeutic exercise CPT code (97110). In the case of mCIT clinical sessions, the signature clinical ingredient is motor learning–based, task-specific practice. During these sessions, patients repetitively engage in deficit components of motor skills that they want to relearn in a systematic fashion, under the guidance of the therapist (ie, part-task practice). Such motor learning/motor control–based techniques are commonly used by therapists working with patients with stroke,21,22 and they are regularly reimbursed using CPT codes listed in Wolf’s letter. Given the above, although the CIT family of therapies and its accompanying techniques (eg, shaping) are a novel advance, we would disagree with the need for creation of a separate CPT code for CIT, which Wolf has been pursuing for several years. We agree with Dr Wolf’s argument that the existence of such a code would stimulate important information regarding CIT’s true clinical utilization and effectiveness (ie, how well it works in real-world environments). However, neither the absence of a code nor the possibility of exciting research questions that could emanate from the existence of such a code is reason enough to create a separate CPT code for CIT. The EXCITE team’s own writings23,24 also note that large gaps remain in our knowledge about CIT. Such significant gaps—and the amount of evidence showing that a variety of practice schedules are efficacious (including availability of several, efficacious, lower-duration CIT variants)—would seem to preclude development of a CPT code for CIT at the intensity that Wolf advocates. With regard to the latter point, we are hard-pressed to imagine why payers would reimburse a therapy requiring 6-hour/day clinical sessions when efficacious, lower-duration alternatives are being validated. In light of the innumerable factors contradicting inception of such a code, one might say that Wolf’s advocacy of a CPT code for CIT is “putting the cart before the horse.” We agree with Dr Wolf’s assertion that research questions should not be molded to fit payer parameters. However, we also wish to respond to Wolf’s implicit speculation that the mCIT clinical component was “molded” to fit parameters of the health care system. Not only does this statement lack factual bases, but Wolf also attempts to use this remark as a foundation for several of his points. The formation of the mCIT clinical component was based on decades of motor-learning research examining the nature of practice (described earlier) and on neurophysiologic evidence showing that neural and motor changes can occur in as little as 15 to 30 minutes. Interestingly, around the same time that we were piloting mCIT, one of Wolf’s eventual EXCITE colleagues wrote that “any technique that induces a patient to use an affected limb…should be considered therapeutically efficacious. This factor is likely to produce the use-dependent cortical reorganization.…”26(p243) This quote suggested to us that it is not just the intensity with which the techniques are provided, but also the nature of the techniques themselves (and, specifically, whether they induce repetitive, task-specific arm use) that influences neural and motor change. Collectively, data from these converging sources suggested to us that functional changes can be observed without intensive clinical practice. Thus, although it is fortuitous that the clinical portion of mCIT is reimbursed, a wide array of scientific literature was consulted in conceiving mCIT’s relatively shorter time parameters. Future Directions: Moving Both the Cart and the Horse Forward For decades, drug and device studies have conformed to a “tried and true,” phased clinical trial process. Through this process, the most efficacious and safe dosing level of a therapy is first identified, followed by larger efficacy and safety studies, and finally a multicenter, controlled efficacy trial (phase III). Unfortunately, rehabilitation researchers, including those involved with CIT, largely have not followed this validated route, especially as it relates to solidifying dose-response issues, a shortcoming expressed as a concern in a recent NIH report.27 We, therefore, agree with Wolf that more research on optimal dosing, timing, adherence, neurophysiologic impact, and other variables must still be examined in relation to CIT and mCIT. In other words, we agree that Wolf’s metaphorical “horse” should advance. However, significantly more information is now available about this family of therapies than when the EXCITE trial was conducted. This is complemented by a wealth of data showing that mCIT is efficacious in all stages poststroke,10,28-32 with a treatment effect that is comparable to CIT.33 As Dr Wolf noted, we also have shown that a variety of therapies (eg, mental practice, electromyographic-triggered electrical stimulation) can act as “bridges” to mCIT participation for patients who are more impaired. Other therapies (eg, telerehabilitative approaches, botulinum toxin A) can be co-administered with mCIT to optimize its efficacy and accessibility. The neural mechanisms underlying mCIT also have been identified.34 Collectively, these factors support advancement toward a phase III mCIT trial, especially given that these same sorts of issues were resolved at a comparable level when the EXCITE Trial moved forward. The “cart,” therefore, also should advance, not at the expense of the “horse,” but in addition to it. Steve Page and Peter Levine S Page, PhD, is Associate Professor, Department of Rehabilitation Sciences and Department of Physical Medicine and Rehabilitation, and Neurosciences Scholar, Institute for the Study of Health, University of Cincinnati Academic Medical Center, Cincinnati, Ohio. P Levine, PTA, is Research Associate, Department of Rehabilitation Sciences, University of Cincinnati Academic Medical Center References 1 Wolf SL, Winstein CJ, Miller JP, et al. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006;296:2095–2104. 2 Bourne LE Jr, Archer EJ. Time continuously on target as a function of distribution of practice. J Exper Psychol. 1956;51:25–33. 3 Baddeley AD, Longman DJ. The influence of length and frequency of training session on the rate of learning to type. Ergonomics. 1978;21:627–635. 4 Wright BA, Sabin AT. Perceptual learning: how much daily training is enough? Exp Brain Res. 2007;180:727–736. 5 Ofen-Noy N, Dudai Y, Karni A. Skill learning in mirror reading: how repetition determines acquisition. Brain Res Cogn Brain Res. 2003;17:507–521. 6 McGaugh JL. Memory—a century of consolidation. Science. 2000;287:248–251. 7 van der Lee JH, Wagenaar RC, Lankhorst GJ, et al. Forced use of the upper extremity in chronic stroke patients: results from a single-blind randomized clinical trial. Stroke. 1999;30:2369–2375. 8 Walker MP, Brakefield T, Hobson JA, Stickgold R. Dissociable stages of human memory consolidation and reconsolidation. Nature. 2003;425:616–620. 9 Uswatte G, Taub E, Morris D, et al. Reliability and validity of the upper-extremity Motor Activity Log-14 for measuring real-world arm use. Stroke. 2005;36:2493–2496. 10 Page SJ, Sisto SA, Levine P. Modified constraint-induced therapy in chronic stroke. Am J Phys Med Rehabil. 2002;81:870–875. 11 Uswatte G, Giuliani C, Winstein C, et al. Validity of accelerometry for monitoring real-world arm activity in patients with subacute stroke: evidence from the EXtremity Constraint-Induced Therapy Evaluation trial. Arch Phys Med Rehabil. 2006;87:1340–1345. 12 Taub E, Uswatte G, King DK, et al. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006;37:1045–1049. 13 Wolf SL, Winstein CJ, Miller JP, et al. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008;7:33–40. 14 Kaplon RT, Prettyman MG, Kushi CL, Winstein CJ. Six hours in the laboratory: a quantification of practice time during constraint-induced therapy (CIT). Clin Rehabil. 2007;21:950–958. 15 Siegert RJ, Lord S, Porter K. Constraint-induced movement therapy: time for a little restraint? Clin Rehabil. 2004;18:110-114. 16 Page SJ, Levine P, Sisto S, et al. Stroke patients’ and therapists’ opinions of constraint-induced movement therapy. Clin Rehabil. 2002;16:55–60. 17 Ploughman M, Corbett D. Can forced-use therapy be clinically applied after stroke? An exploratory randomized controlled trial. Arch Phys Med Rehabil. 2004;85:1417–1423. 18 Taub E, Miller NE, Novack TA, et al. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993;74:347–354. 19 Miltner W, Bauder H, Sommer M, et al. Effects of constraint-induced movement therapy on patients with chronic motor deficits after stroke: a replication. Stroke. 1999;30:586–592. 20 Blanton S, Wolf SL. An application of upper-extremity constraint-induced movement therapy in a patient with subacute stroke. Phys Ther. 1999;79:847–853. 21 Jette DU, Latham NK, Smout RJ, et al. Physical therapy interventions for patients with stroke in inpatient rehabilitation facilities. Phys Ther. 2005;85:238–248. 22 Latham NK, Jette DU, Coster W, et al. Occupational therapy activities and intervention techniques for clients with stroke in six rehabilitation hospitals. Am J Occup Ther. 2006;60:369–378. 23 Wolf SL. Revisiting constraint-induced movement therapy: are we too smitten with the mitten? Is all nonuse “learned”? and other quandaries. Phys Ther. 2007;87:1212–1223. 24 Taub E, Uswatte G. Constraint-induced movement therapy: answers and questions after two decades of research. NeuroRehabilitation. 2006;21:93–95. 25 Wu CY, Chen CL, Tsai WC, et al. A randomized controlled trial of modified constraint-induced movement therapy for elderly stroke survivors: changes in motor impairment, daily functioning, and quality of life. Arch Phys Med Rehabil. 2007;88:273-278. 26 Taub E, Uswatte G, Pidikiti R. Constraint-induced movement therapy: a new family of techniques with broad application to physical rehabilitation—a clinical review. J Rehabil Res Dev. 1999;36:237-251. 27 National Institutes of Health, National Institute of Child Health and Human Development. Timing, Intensity, and Duration of Rehabilitation for Hip Fracture and Stroke Workshop Summary. Washington, DC: National Institute of Child Health and Human Development, NIH, DHHS; 2001. Available at: http://www.nichd.nih.gov/publications/pubs/upload/rehab_hip_stroke_2001.pdf. Accessed April 7, 2008. 28 Page SJ, Levine P, Leonard AC. Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2005;19:27–32. 29 Page SJ, Sisto SA, Levine P, et al. Modified constraint induced therapy: arandomized, feasibility and efficacy study. J Rehabil Res Dev. 2001;38:583–590. 30 Page SJ, Sisto S, Johnston MV, Levine P. Modified constraint-induced therapy after subacute stroke: a preliminary study. Neurorehabil Neural Repair. 2002;16:223–228. 31 Page SJ, Sisto S, Levine P, McGrath RE. Efficacy of modified constraint-induced therapy in chronic stroke: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2004;85:14–18. 32 Page SJ, Levine P, Leonard A, et al. Modified constraint-induced therapy in chronic stroke: results of a single-blinded randomized controlled trial. Phys Ther. 2008;88:333–340. 33 Hakkennes S, Keating JL. Constraint-induced movement therapy following stroke: a systematic review of randomised controlled trials. Aust J Physiother. 2005;51:221–231. 34 Szaflarski JP, Page SJ, Kissela BM, et al. Cortical reorganization following modified constraint-induced movement therapy: a study of 4 patients with chronic stroke. Arch Phys Med Rehabil. 2006;87:1052–1058. |
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Steven L. Wolf, physical therapist Emory University School of Medicine
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swolf{at}emory.edu Steven L. Wolf
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Over the past 6 years, Stephen J Page, PhD, FAHA, has shown a remarkable level of research productivity with considerable efforts directed toward a modification of constraint-induced movement therapy (mCIMT)—or constraint-induced therapy (mCIT)—and its interfaces with other modalities or approaches, including functional electrical stimulation, electromyographic-triggered electrical stimulation, telerehabilitation, and mental practice. These efforts have resulted in the genesis of a perspective that mCIT is a reimbursable procedure1,2 or “a reimbursable protocol.”3(p339) Before this form of mCIT progresses toward the next logical step—a phase III randomized controlled study—a pause for reflection may be in order. This response is intended to offer a critical assessment and allows us to contemplate if, indeed, the cart is being placed too far before the horse. Evaluating the Signature Form of CIT in Light of mCIT The “signature” form of CIT requires intensive practice, the primary factor that differentiates it from the distributed practice forms of CIT that generally have been referred to as “modified.” Undoubtedly, there are frustrations that might occur with such concentrated effort required over 10 or 15 weekdays of training for up to 6 hours per day. In the recently completed EXtremity Constraint-Induced Therapy Evaluation (EXCITE) Trial,4,5 the average duration of daily training (actual time on task) over 10 days using repetitive task practice and adaptive task practice (shaping) was 3 hours. Many of the 222 EXCITE participants simply did not possess the endurance to train for the entire 6 hours; in fact, the average time progressed from 1.5 hours to 4.5 hours. Given a mean of 3 hours over 10 days, the total on-task time was 30 hours for the signature CIT that characterized EXCITE. In contrast, the present study3 used approximately half that time (1.5 hours of clinic-based training per week over 10 weeks, for a total of 15 contact hours). However, mCIT as used here had far more restraint of the less-affected upper limb (5 hours/day in the home for 5 days for each of 10 weeks, or a total of 250 limb-restricted hours) compared with EXCITE (9 hours per day over 14 days, or 126 hours of limb-restricted hours). Thus, the fundamental clinical research question might be: what specific self-training is undertaken in the home environment that leads to these documented improvements in the Motor Activity Log (MAL)?6,7 (The MAL is an outcome measure of real-world usage of the impaired upper-extremity that is common to EXCITE,4 the present study,3 and constraint therapy investigations from several laboratories.8-14) This consideration is important, because the improvements seen in the present study and most other papers written by Page and colleagues on this subject far exceed what have been seen by other investigators. Because the baseline scores are not provided here, readers can only deduce from the change scores that mean Amount of Use or Quality of Movement MAL scores must have eclipsed a 3/5, which is indicative of independent use of the impaired upper extremity that is in excess of those scores reported by most, if not all, other investigators. Provision of the home-based training program that the Page lab uses would be of immense value to those in the neurorehabilitation community who are interested in using any form of CIT. This phase of their mCIT occupies 94.3% of the treatment time (250 home-based hours/250 home-based hours + 15 clinic hours). Clearly, there are important elements that foster a unique sequencing of tasks coupled with monitoring of task dosing and patient adherence. Parenthetically, although presumably the 30-task version of the original MAL was used as an outcome measure in the current study, recent data suggest that the patient Amount of Use portion of the MAL does not have reliability and should be used with caution.15 This observation is in distinct contrast to a chronologically earlier reference cited in the present work regarding the reliability and validity of the Amount of Use and Quality of Movement scales of the MAL.16 Revisiting Limitations in the Delivery of “Signature” CIT There is little question that the signature form of CIT is intensive. The extent to which such concentrated effort is perceived by patients or therapists as disinterest or impracticality has been cited by Page and colleagues through results published in 2002 from a questionnaire administered in the Northeast United States.17 Although EXCITE has not performed a local, regional, or national survey, we did provide an exit interview among EXCITE participants. Twenty-four months after enrollment, 73 participants from 5 EXCITE locations were asked to rate the helpfulness of the training intensity in achieving results, using a 7-point scale (1=not helpful and 7=very helpful). A mean response of 6.21±1.07 was reported. Informal discussion with physical therapists and occupational therapists conducted at lectures and workshops throughout the United States has resulted in an overwhelming consensus that the limiting factor is not disinterest or time, but concern for adequate reimbursement relative to the time required to deliver the treatment. As further evidence for the impracticality of the signature CIT approach, Page and colleagues1,3,18 frequently cite the following excerpt from our case study19: “…the patient…grew tired of wearing the mitt and had difficulty with full adherence…. 'cheating’ with the uninvolved hand was a frequent temptation.”3(p334) However, the last portion of the passage—“but she responded well to verbal encouragement and gentle reminders to use the limb appropriately”19(p851)—is not included in the cited text. This latter part of the passage lends valuable insight into the role of therapists and caregivers in supporting the patient during challenging tasks. Furthermore, even in the presence of potential nonadherence, the patient did remarkably well. Unfortunately, taken out of context, the full impact of the discussion point is lost. Mitt wearing adherence is an important concern and frequently is used to support the use of a modified version of CIT. However, it is important to note that mCIT as described by Page et al actually demands more mitt wearing time (250 hours versus approximately 126 hours in the EXCITE Trial). From our extensive experience in treating or overseeing the administration of interventions, we have rarely seen patients who are totally satisfied with the nature of an intervention or with the extent of their progress or who have not strayed from full adherence, regardless of impairment severity or functional limitation, including patients exposed to modifications of CIT. With these concerns in mind, perhaps a more prudent and scientifically valid approach to clarification—if not resolution of differences between the concentrated version of CIT and mCIT as defined in this study—would be a well-controlled comparison. The Alternative Treatment: Proprioceptive Neuromuscular Facilitation (PNF) Techniques and Functional Tasks Approximately 80% of the treatment time for the alternative intervention was devoted to PNF techniques, with the remainder of the time centered on “functional tasks” and stretching of upper-extremity joints. Indeed, our fairly extensive review of the literature (Physiotherapy Evidence Database [PEDro], available at www.pedro.fhs.usyd.edu.au and accessed March 3, 2008) confirms the observations deduced from the source reference in the present article20 that the evidence supporting favorable outcomes using PNF techniques is weak. The selection of an alternative therapy that included specific elements of upper-extremity training—such as strengthening and repetitive task practice (for which literature supporting functional improvement following stroke has emerged21-24) with the intent to equilibrate the amount of practice targeting manipulation of the environment comparable to that which is embodied in mCIT—may have offered clearer evidence supporting the unique attributes of mCIT. The indication by Page et al that comparison interventions in their future studies will include these considerations is encouraging. Other Queries In the present study, efforts were made to ensure that participating clinicians were unaware of study hypotheses. In designating interventional roles for clinicians in many of our past studies, we have never made an attempt to disguise the study hypotheses, for 2 reasons. First, we feel that clinicians' knowledge about the intent of a study is important for fostering proactive involvement, and, second, we are certain that their inherent intellect and training would allow them to easily deduce the hypotheses anyway. This reality is particularly relevant in the present study, given that various forms of CIT are well-publicized, and, in this case, the intervention is being overseen by someone known to have been investigating it for several years. The neurorehabilitation research community would be well-served if the present investigators could inform us about how they succeeded in ensuring that participating clinicians never became aware of study hypotheses. Similarly, patients recruited into the present study apparently “…were not informed of the group in which the greatest changes were anticipated.”3(p339) I am hard-pressed to understand how prospective patient subjects would not form an opinion regarding which groups would be expected to show the greatest changes. Given the inquiry processes of patients and their caregivers, and given the easy access to contemporary information retrieval resources, clinical researchers might be able to learn from Page and colleagues how to avoid participant exposure to such readily available knowledge from which obvious expectations would arise prior to randomization. mCIT: A Reimbursable Procedure/Protocol? Perhaps the most contentious issue raised in this paper is the claim that mCIT is a reimbursable procedure or protocol. The concern here is not one of semantics but of legality. The Centers for Medicaid and Medicare Services (CMS) are quite clear in their operational definitions of current procedural terminology (CPT) codes.25 Neither mCIT nor CIT is a reimbursable procedure, as there is not yet a specified code identified for either approach. Currently, therapists or physicians undertaking the training and performing the billing often utilize CPT codes such as 97535 (self-care/home management), 97110 (therapeutic exercise), 97112 (neuromuscular reeducation), or 97530 (therapeutic activities to improve functional performance). It is important to note that each of these CPT codes is defined for a specific intervention in an effort to appropriately document therapeutic treatment. A more accurate construct for the billing might be expressed, for example, as “…reimbursement for mCIT as a therapeutic exercise under CPT 97110…. for a specified number of deliverable time intervals.” Continuing to identify mCIT as simply “…reimbursable using existing CPT codes”3(p339) without also noting the lack of a specific mCIT code is confusing and misleading to both clinicians and policy makers and perpetuates a misuse of CPT codes. In this context and as noted previously, the distributed practice embedded within mCIT represents a departure from the more “signature” form of CIMT first described by Taub et al26 and does represent an avenue of research that may be essential to better understand dosing while serving to meet immediate needs of the current health care environment. However, the long-term effects of molding our research questions to such a restrictive system ultimately may do more harm than good. In the immediate sense, reimbursement with the delivery of mCIT is very encouraging, yet the importance of knowing that there is no current CPT code for CIT cannot be underestimated. The listing of medical service codes and procedures describing therapeutic services provides a uniform language that serves as a consistent and reliable means of nationwide health care communication among clinicians, patients, and third parties.27 Not only is this information used by public and private health insurance programs, it is used for administrative management purposes, such as claims processing, medical care guidelines, and medical education and research comparisons. Current code descriptions do not adequately describe the intensity or the content of this intervention. Thus, development of a true CIT CPT code, with all its justifiably documented models of delivery, is critical for future documentation of utilization and process evaluation of CIT within clinical practice. Continuing to settle for billing of this intervention through imprecise descriptors only serves to narrow a future vision of neurorehabilitation based on true evidence-based practice and undermines legitimate efforts to place extensive research data in a proper context.28 Thus, an assertive, proactive approach to foster change in reimbursement policies demands that evidence drive the system. One of the most critical components to provide a foundation to garner health care change is the consistent utilization of standardized outcome measures. In July 2007, Medicare’s first performance-based bonus system was implemented.28 Support has been provided from Congress, CMS, and the Medicare Payment Advisory Commission (MedPAC) to establish policies that reward providers for efficient use of resources and create incentives to increase quality of care. In short, this “pay for performance” trend is thought to link payment to quality of care by health care practitioners. This was limited in 2007 to fall-risk screening in physical therapy, but policy makers are interested in future implantation of pay-for-performance programs in Medicaid and third-party payer service, and clinicians should be forward-planning in their practice structures.29 The extent to which comprehensively documented effectiveness studies in the area of upper-extremity task practice in neurorehabilitation embraces this forward planning should be beyond dispute. Future Studies: The Horse-Cart Conundrum There are several modifications of the signature CIT application, each with its own unique form of distributed practice and training elements. There is little question that monitoring dosing is an important consideration and one that has been under-appreciated in many neurorehabilitation studies.30 However, before a phase III clinical trial can be undertaken, it seems reasonable to first compare various forms of mCIT—as discussed by Page31—to determine if one form of modification is superior to another, controlling for patient attributes and dosing. With respect to the latter variable, recent analyses from the EXCITE Trial would suggest that with the application of the signature form of CIT, there is no succinct relationship between intensity of training and outcome among participants who showed statistical and clinically meaningful improvements.32 Thus, there is a need for determining those factors leading to an optimal form of distributed practice with constraint-induced therapy before embarking on a larger scale exploration. At that time, hitching the cart to the horse would make sense. Steven L Wolf, PT, PhD, FAPTA, FAHA Professor, Departments of Rehabilitation Medicine and Medicine, and Associate Professor, Department of Cell Biology, Emory University School of Medicine, Center for Rehabilitation Medicine; Professor, Health and Elder Care, Nell Hodgson Woodruff School of Nursing at Emory University; Senior Research Scientist, Atlanta VA Rehab R&D Center. Acknowledgments I thank Sarah Blanton, PT, DPT, for invaluable discussion and input, and Paul Hansen and Kathleen Zettergren for their correspondence regarding PNF studies in response to a NeuroPT list serve posting. References 1 Page SJ, Levine P. Modified constraint-induced therapy in patients with chronic stroke exhibiting minimal movement ability in the affected arm. Phys Ther. 2007;87:872-878. 2 Page SJ, Levine P, Hill V. Mental practice as a gateway to modified constraint-induced movement therapy: a promising combination to improve function. Am J Occup Ther. 2007;61:321-327. 3 Page SJ, Levine P, Leonard A, et al. Modified constraint-induced therapy in chronic stroke: results of a single-blinded randomized controlled trial. Phys Ther. 2008;88:333-340. 4 Wolf SL, Winstein CJ, Miller JP, et al. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006;296:2095-2104. 5 Wolf SL, Winstein CJ, Miller JP, et al. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008;7:33-40. 6 Winstein CJ, Miller JP, Blanton S, et al. Methods for a multisite randomized trial to investigate the effect of constraint-induced movement therapy in improving upper extremity function among adults recovering from a cerebrovascular stroke. Neurorehabil Neural Repair. 2003;17:137-152. 7 Uswatte G, Taub E, Morris D, et al. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006;67:1189-1194. 8 Brogardh C, Sjolund BH. Constraint-induced movement therapy in patients with stroke: a pilot study on effects of small group training and of extended mitt use. Clin Rehabil. 2006;20:218-227. 9 Dromerick AW, Lang CE, Birkenmeier R, et al. Relationships between upper-limb functional limitation and self-reported disability 3 months after stroke. J Rehabil Res Dev. 2006;43:401-408. 10 Fritz SL, George SZ, Wolf SL, Light KE. Participant perception of recovery as criterion to establish importance of improvement for constraint-induced movement therapy outcome measures: a preliminary study. Phys Ther. 2007;87:170-178. 11 Lin KC, Wu CY, Wei TH, et al. Effects of modified constraint-induced movement therapy on reach-to-grasp movements and functional performance after chronic stroke: a randomized controlled study. Clin Rehabil. 2007;21:1075-1086. 12 Malcolm MP, Triggs WJ, Light KE, et al. Repetitive transcranial magnetic stimulation as an adjunct to constraint-induced therapy: an exploratory randomized controlled trial. Am J Phys Med Rehabil. 2007;86:707-715. 13 Wu CY, Chen CL, Tsai WC, et al. A randomized controlled trial of modified constraint-induced movement therapy for elderly stroke survivors: changes in motor impairment, daily functioning, and quality of life. Arch Phys Med Rehabil. 2007;88:273-278. 14 Wu CY, Lin KC, Chen HC, et al. Effects of modified constraint-induced movement therapy on movement kinematics and daily function in patients with stroke: a kinematic study of motor control mechanisms. Neurorehabil Neural Repair. 2007;21:460-466. 15 Uswatte G, Taub E, Morris D, et al. Reliability and validity of the upper-extremity Motor Activity Log-14 for measuring real-world arm use. Stroke. 2005;36:2493-2496. 16 van der Lee JH, Beckerman H, Knol DL, et al. Clinimetric properties of the motor activity log for the assessment of arm use in hemiparetic patients. Stroke. 2004;35:1410-1414. 17 Page SJ, Levine P, Sisto S, et al. Stroke patients' and therapists' opinions of constraint-induced movement therapy. Clin Rehabil. 2002;16:55-60. 18 Page SJ, Levine P, Leonard AC. Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2005;19:27-32. 19 Blanton S, Wolf SL. An application of upper-extremity constraint-induced movement therapy in a patient with subacute stroke. Phys Ther. 1999;79:847-853. 20 Lord JP, Hall K. Neuromuscular reeducation versus traditional programs for stroke rehabilitation. Arch Phys Med Rehabil. 1986;67:88-91. 21 Patten C, Lexell J, Brown HE. Weakness and strength training in persons with poststroke hemiplegia: rationale, method, and efficacy. J Rehabil Res Dev. 2004;41:293-312. 22 Lum PS, Patten C, Kothari D, Yap R. Effects of velocity on maximal torque production in poststroke hemiparesis. Muscle Nerve. 2004;30:732-742. 23 Winstein CJ, Rose DK, Tan SM, et al. A randomized controlled comparison of upper-extremity rehabilitation strategies in acute stroke: a pilot study of immediate and long-term outcomes. Arch Phys Med Rehabil. 2004;85:620-628. 24 Winstein CJ, Stewart JC. Conditions of task practice for individuals with neurologic impairments. In: Selzer SC, Cohen LG, Duncan PW, Gage FH, ed. Textbook of Neural Repair and Rehabilitation. Vol 2. New York, NY: Cambridge Press; 2006:89-102. 25 AMA Current Procedural Terminology, 2008. Salt Lake City, Utah: Ingenix; 2008. 26 Taub E, Miller NE, Novack TA, et al. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993;74:347-354. 27 US Department of Health and Human Services. HCPCS Coding Questions. 2.22.2006. Available at: http://www.cms.hhs.gov/MedHCPCSGenInfo20_HCPCS_Coding_Questions.asp#TopOfPage. Accessed October 4, 2007. 28 Blanton S, Wilsey H, Wolf SL. Constraint-induced movement therapy in stroke rehabilitation: perspectives on future clinical applications. NeuroRehabilitation. 2008;23:15-28. 29 Lee G. Performance-based payment: a tentative first step. PT Magazine. 2007;15(6):26-28. 30 Wolf SL, Winstein CJ, Miller JP, et al. Looking in the rear view mirror when conversing with back seat drivers: the EXCITE trial revisited. Neurorehabil Neural Repair. 2007;21:379-387. 31 Page SJ, Wu C, Lin K. Letter to the editor. Neurorehabil Neural Repair. 2007;21:574-575. 32 Wolf SL, Newton H, Maddy D, et al. The EXCITE Trial: relationship of intensity of constraint induced movement therapy to improvement in the Wolf Motor Function Test. Restor Neurol Neurosci. 2007;25:549-562. |
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