Stephanie C. DeLuca, PhD
Sharon Landesman Ramey, PhD
Steven L. Wolf, PT, PhD, FAPTA
Constraint-Induced Movement Therapy (CIMT) began more than two decades ago as a novel therapeutic approach that has helped individuals with hemiparesis achieve improvement in movement, skills, and function. “CIMT protocols” yield >90,000 in Google Scholar (on 1-14-21). This new body of knowledge spans the translational spectrum of biomedical science. Recent and ongoing CIMT clinical trials are poised to transform medical rehabilitation: e.g., I-ACQUIRE (NCT03910075) is the first-ever Phase 3 dosage trial focused on CIMT for infants with perinatal stroke; TRANSPORT 2 (NCT03826030) is a Phase 2 trial testing neuromodulation with CIMT post-stroke; and a tele-rehabilitation trial is a Phase 3 trial demonstrating non-inferiority of a tele-rehab version of CIMT compared to traditional in-person delivery1. Core distinguishing characteristics of CIMT include: 1) constraint of the uninvolved or less-impaired upper extremity (UE); 2) high-density dosage of active therapy; and 3) therapy involving principles of operant conditioning and motor learning, including reinforcement with explicit feedback to induce and then shape new UE behaviors through successive approximations and repetitive and varied task practice2-5. This paper advances the premise that CIMT scientific inquiry has paved the way for a broader medical rehabilitation agenda by exemplifying use of basic science findings, implementing rigorous RCT methods, and proposing novel concepts about future directions for the field.
The principles informing CIMT and incorporated into CIMT clinical trials increasingly are being woven into rehabilitation science and clinical practice. These include hypotheses about treatment induced neuroplasticity; the efficacy of other forms of high-density ‘intensive’ therapies, such as bimanual therapy6; the need for well-defined and thus replicable rehabilitation protocols that can be monitored for treatment fidelity; and the exploration of potential biomarkers, such as genes regulating dopamine that may mediate differential patient outcomes7 8. CIMT research in both adults and children has encountered well-recognized issues concerning natural heterogeneity in clinical populations and major limitations in identifying primary and secondary treatment outcomes that can adequately capture benefits meaningful to patients and clinicians. Many CIMT trials now serve as models of team science with scientists, clinicians, caregivers, and patients/advocates working collaboratively towards these goals.9-12
A next-step in CIMT moves the field toward a vision of precision rehabilitation: the awareness that individuals vary both biologically and behaviorally in ways that may impact treatment decision making, response, and outcomes13 14. Results from systematic empirical inquiry focused on individual differences may lead to far better matching of which individuals should receive what types and dosages of CIMT, alone or in combination with other interventions (e.g., neuromodulation, bimanual therapy, wearable sensors), and at what timepoints in their lives. Framing the next era of CIMT clinical trials and meta-analyses of existing datasets in terms of precision rehabilitation also offers an unprecedented opportunity for improving long-term quality of life for individuals whose neuromotor impairments – when not adequately treated – create major limits for their health (including multiple secondary disabilities), employment, and full community participation. Precision-rehabilitation as a framework benefits immeasurably by engaging key stakeholders — scientists, patients, clinicians, and health care systems and policy experts — in the design, conduct, analysis, and interpretation of results from rigorous clinical trials.
Early studies of pediatric CIMT (P-CIMT) reported what were considered unanticipated benefits or “spillover effects” that included changes in multiple domains not specifically designated as CIMT treatment goals, including improved speech, posture, ambulation, social interactions, reduction of behavior problems, and willingness to engage in challenging learning activities15-17. These early anecdotal and qualitative observations contributed to a shift in rehabilitation science that now explicitly recognizes the need to measure changes that go beyond direct indicators of neuromotor impairment. These concepts include considerations related to overall health, perceived well-being, individual agency, and engagement in community activities and hypothesize these are important targets to incorporate when designing, planning, and implementing an intervention.
Behaviorally focused and high-density interventions, such as CIMT, now are merging with biomedical engineering approaches (e.g., neuromodulation, biofeedback wearable sensing devices), genomics (e.g., genetic markers that predict responsiveness to interventions), and kinematic behavioral measurement to identify bio-behavioral markers to consider in tailoring rehabilitation to maximize functional health and well-being across the life-span18-20. Thus, in many ways scientific investigation surrounding CIMT has paved the way for adopting precision-rehabilitation as a guiding conceptual framework.14
CIMT in the context of translational science
One way in which CIMT has undergirded precision-rehabilitation is through its history, starting with animal model experiments. The experiments were designed to identify how learning impacts motor (efferent) pathways when sensory (afferent) pathways were experimentally disconnected (deafferented)21. After unilateral deafferentation of a forelimb at the dorsal root entry of the spinal cord, at various times in development, post-deafferentation procedures documented differential forelimb use. Somewhat surprisingly, animals could be directed (or “forced”) via extended constraint of the intact forelimb coupled with various training methods to use the deafferented forelimb in daily life, despite lack of sensory input.21 22. This contradicted prior findings of permanent paralysis in a deafferented forelimb22 and led to two novel insights for the neurorehabilitation community: 1) expression of a disability might not match the actual nervous system anatomical damage; and 2) recovery from CNS damage might be more amenable to behavioral interventions than previously thought21. This basic science work was foundational for Steve Wolf’s first human stroke case studies23 that “forced use” of the hemiparetic arm-and-hand by constraining the functioning arm-and-hand. Then Nudo24 et.al conducted seminal research using a non-human primate stroke model that applied constraint with behavioral training, resulting in discovery of a dose-dependent cortical expansion associated with the intervention24. Collectively, these findings combined to create what ultimately became CIMT.
Next in the CIMT translational process was the design and conduct of “The Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial,” the first NIH-funded multisite Phase 3 clinical trial involving 7 sites and >200 patients with chronic stroke12 25. EXCITE directly compared outcomes from a well-delineated CIMT protocol to usual and customary rehabilitative care (UCC)12. EXCITE demonstrated that CIMT produced significant and clinically relevant benefits compared to UCC, with benefits extending at least 24 months post-intervention, suggesting potential permanency of benefits. An important feature of EXCITE was that participants were 3-9 months post-stroke, when they traditionally exceeded eligibility for active treatment, based on the assumption (untested) that further progress was unlikely to occur. Half were randomly assigned to receive CIMT immediately and half did not, although they could receive other therapies for a year. The UCC group then received the 2-week intensive CIMT a year later. Both the initial Immediate CIMT group and the delayed CIMT group showed significant gains on the WOLF Motor Function Test, while the UCC group did not. Additional measures included self-report about amount and quality of upper extremity use (Motor Activity Log) and quality of life (Stroke Impact Scale) demonstrating time-appropriate significant improvements. Then, the same EXCITE CIMT protocol and participant inclusion criteria was tested on another sample, producing comparable findings12 25 with new evidence from transcranial magnetic stimulation revealing for the first time in humans that CIMT induced cortical expansion of the muscle groups contributing to wrist extension immediately post-treatment and 4-months later26. Once again functional improvements were maintained26 27. Several interdisciplinary teams of developmental psychologists, therapists, pediatric neurologists, and neuroscientists began to adapt the adult CIMT approach for children17 28 29. For example, DeLuca, et al. developed a novel form of CIMT for a 15-month old with asymmetric quadriparesis that was implemented at two time periods 17. Their novel adaptation involved a rigid full-arm constraint worn full-time, unlike the adult constraint worn during most waking hours only. The cast was introduced because very young children, unlike adult stroke patients, were not restoring prior skills but acquiring skills for the first time. The cast effectively and almost immediately re-directed the child’s attention to the hemiparetic UE. The child rapidly gained reaching abilities, a whole-hand palmer grasp, and sitting balance for the first time in her life during the first P-CIMT session. Then during the second P-CIMT episode at 21 months old, the child added many new fine-motor abilities and learned to crawl. Taub, et al. then completed the first pediatric RCT which demonstrated P-CIMT produced significantly greater gains in new UE skills, as well as frequency and quality of use, in 2- to 8-yr old children with hemiparesis15. Further, the immediate large gains were maintained or increased over the next 6 months. This tested form of P-CIMT involved 6 hours of daily intervention with a full-time cast over 20 treatment days (120 hours) compared to UCC which averaged 2.2 hours per week. When UCC controls were crossed over to receive P-CIMT, similar results obtained15. Charles and Gordon, demonstrated similar positive benefits for P-CIMT via a set of case-reports in 200129, and later went on to demonstrate that a high-intensity bimanual approach to therapy, informed by the same foundational learning principles first applied in CIMT, also was highly efficacious in helping children with hemiparesis gain increased function and skill with their hemiparetic UE6.
Variations and adaptations of CIMT
Clinical and research interest in CIMT continues to grow. Two decades later, many variations in pediatric and adult CIMT have been described and evaluated, with variations related to the type and duration of constraint, therapy dosage, guiding principles for the choice and progression of tasks and activities, and who delivers the treatment. Unfortunately, these treatment protocols often lack specific written descriptions; seldom is intervention fidelity monitored and reported. As a result, opportunities to learn about the relative merits of these protocol variations are precluded. Reiss, et.al. were among the first to emphasize the importance of better understanding these “modified CIMT” approaches4. They recognized both “strengths and weaknesses” of protocol variations compared to what they termed the “signature” highly intensive CIMT approach that employed operant conditioning techniques with feedback to patients, as originally tested in the adult RCTs. Similarly, Ramey, et.al. proposed 5 necessary or essential components for P-CIMT models that serve to differentiate the forms labelled “signature,” “modified,” and “alternative” P-CIMT5. Operationalizing differences across CIMT approaches for adults and children drew attention to the criticality of detailed documentation of rehabilitation interventions. CIMT, like many prior rehabilitation treatments, was now becoming so varied that any meta-analysis or systematic comparative efficacy analysis was problematic. Additionally, differences in the targeted clinical populations regarding etiologies, severity of hemiparesis, co-morbidities, ages, and lack of a single best or widely used outcome measure further challenged translating results of published research into evidence-based guidelines. Consequently, in practice, clinicians and patients/parents often choose their own versions of a “CIMT approach,” with little to no evidence to substantiate that these creative versions offer sufficient dosage, constraint, and/or adherence to enacting principles of operant conditioning and motor learning to yield meaningful or enduring benefits. In fact, most published CIMT studies are relatively small-scale Phase 2 clinical trials or clinical case series. TABLE 1 defines signature CIMT’s core elements.
Finally, a future remaining step for CIMT inquiry is to conduct Implementation Science trials to determine effective strategies that will promote widespread adoption of treatment protocols proven efficacious – including demonstrating high fidelity in a variety of clinical settings and across heterogeneous clinical populations14 30-32. As results emerge from CIMT research and rehabilitation trials across the lifespan, patients and clinicians will benefit immensely from the resulting knowledge. CIMT challenged clinical assumptions about the course of recovery Since its inception, CIMT outcomes document far greater potential for improvement during the chronic period after CNS injury, as well as a likely threshold for density dosage (high amounts of therapy in relatively short periods of time) to realize clinically meaningful and enduring gains. These discoveries overturn long held but incorrect assumptions that after early periods of recovery little or no progress could occur. Additionally, other widely-used rehabilitation treatments failed to demonstrate efficacy33 34. The rehabilitation field rarely considered that implicit attitudes (or biases) of low expectations for recovery might have influenced participation in rehabilitation and, in turn, negatively impacted treatment outcomes.
Typically, most patients received a mix of different daily therapy treatments while hospitalized, followed by a fixed duration of “rehabilitation” in a rehabilitation center (or early intervention program for young children), and then either ended rehabilitation or reduced to a low dose of one or two hours/week. Many patients were exposed to multiple therapists who focused on different aspects of recovery – including occupational, physical, speech language, and psychological therapy along with social work supports – but patients/parents often received discrepant or conflicting advice. Logistical difficulties and lack of coordination across providers and complexities of insurance coverage likely contributed to sub-optimal benefits. In contrast, the highly successful approach CIMT offered was a commitment to a very high, concentrated dosage of therapy, informed by research evidence and principles of learning about massed practice that promotes functional movement and CNS re-organization. Further, these highly dense therapy periods most often are guided by a single provider following a specified protocol with clear expectations for participation (with known start and stop points) for patients and their care-partners.
Towards an Integrated Precision-Rehabilitation Framework
FIGURE 1 provides a view of how an integrative collaboration among investigators, across the translational science continuum, might blend with knowledge and insights from clinicians, patients, their families (advocates), and health care system administrators. Leadership for realizing this framework can be shared and include continuous updating about rehabilitation topics regarding the targeted patient population (e.g., CNS insult, age group) and the types of interventions being studied. Ideally, with shared lifespan goals of improving health, participation, and quality of life, treatments in the community need to be studied in terms of immediate, direct, and objective benefits plus multi-domain health and functional outcomes. This approach leads to emphasis on the value of timely and transparent sharing of public use clinical trials datasets (a requirement in most NIH trials), and the potential value of conducting clinical trials that specifically test combinations of therapies – reflecting more accurately what both adults and children receive in their communities – along with testing sequential or repeated courses of treatment. Further, remarkably little research has considered documenting the natural events or patient-initiated types of activities that may enhance (or limit) benefits related to the tested interventions. Finally, by including promising biomarkers that theoretically could differentiate which individuals benefit more (or less) from specific forms of CIMT and other intensive therapies, the precision-rehabilitation framework could yield an impact far beyond the already known results of independent RCTs. EXCITE was perhaps among the first study to document that individualization could occur via a multi-component behavioral intervention, because patients naturally vary in their baseline performance. Similarly, other pediatric RCTs have been designed as comparative efficacy clinical trials, manipulating dose and type of constraint (e.g., CHAMP11); or contrasting unilateral and bilateral approaches for infants of comparable dosage (Baby CHAMP) or for older children, or manipulating dose alone (I-ACQUIRE).
These and other studies were explicitly conceptualized to resolve some of the pressing clinical choices in the P-CIMT protocol to use with particular patient populations. Increasingly, many of these trials now include measuring outcomes in multiple domains and collect biomarker data to explore genetic and other biological differences (e.g., dopamine regulation, typical cortisol rise, new methods of coding CNS infarcts). As the precision-rehabilitation framework is more widely adopted, the field likely will benefit and extend into Implementation Science35 to understand how to ensure high fidelity and equitable implementation of efficacious rehabilitation in real world settings, recognizing individual differences and pragmatic factors.
Integration of Biotechnology Advances in Precision Rehabilitation
Rehabilitation professionals have a daunting task in this expanding era of precision-rehabilitation which will encourage patients to be empowered and true partners in their own rehabilitation. Computer-assisted technologies in mobility, robotic use of limbs, and communication assistive devices all have made impressive and potentially transformative advances for individuals with neuromotor impairments. Rehabilitation science is also facing the issue of integrating new technologies: for example, the ability to alter gene expression and functioning with technologies such as CRISPR and application of direct neuromodulation in combination with behavioral interventions. Often these exciting advances are celebrated long before they have been rigorously tested for safety, feasibility, benefits, and potential long-term iatrogenic effects. For example, while computer-based compensatory technologies aid individuals in negotiating the environment, there is a risk that some treatment plans may inadvertently neglect a concomitant need to have patients maximize their neuromuscular competence and realize improved health, achieving a balance between use oftechnology and self-initiated movement. Finding this right balance of technology, environmental accommodation(s), and individual functional competencies is never easy.
FIGURE 1: Precision Practice: A Translational Systems Framework Integrating Current Research, Rehabilitation Practices, and Supported Networks to Promote Knowledge and Information Resources for Practitioners (adapted from S. Ramey, Coker-Bolt & DeLuca, 2013; National Research Council, 2011).
Ideally, future clinical trials will systematically test multiple interventions and innovative uses of technology, as independent treatment processes and combined when appropriate. This step is a necessary precursor to allow science to guide the implementation of varied approaches.
Conclusion and Future Directions
Choices about rehabilitation treatments should involve joint decision-making among patients and clinicians, guided by accessible scientific findings. Historically, rehabilitation professionals have had scant information to share with patients about efficacy of most forms of available treatments. Continued design and conduct of Phase 2 and Phase 3 neurorehabilitation trials – with better measurement of patient characteristics, environmental features, treatment fidelity, and a more “total person” perspective of meaningful outcomes can benefit from discoveries over the past two decades of scientific inquiry into CIMT. The Eunice Kennedy Shriver National Institute of Child Health and Human Development has put forward new Rehabilitation Research themes which include: 1) rehabilitation across the lifespan; 2) community and family; 3) technology use and development; 4) research design and methodology; 5) translational science; and 6) building research capacity and infrastructure36. These themes represent an ambitious and achievable vision with the potential to transform the practice of evidence-based rehabilitation and the overall health, functioning, and quality of life for individuals whose neuromotor control and subsequent development have been altered by CNS damage or disease.
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Stephanie C. DeLuca, PhD is a developmental scientist who has examined the impact of intensive neurorehabilitation treatments on children and adults with neuromotor impairments. Dr. DeLuca’s interdisciplinary research has includednumerous phase II and Dr. DeLuca is an Associate Professor at the Fralin Biomedical Research Institute with additional appointments in the Department of Pediatrics and the School of Neuroscience, Virginia Tech. In addition, Dr. DeLuca serves as a member of the National Advisory Board on Medical Rehabilitation Research for the Eunice Kennedy Shriver National Institute of Child Health and Human Development and on the Research Committee for the International Alliance of Academies of Childhood Disabilities.
Sharon Landesman Ramey, PhD, is a developmental scientist who over the past 5 decades has been a pioneer in the development and testing of many innovative forms of pediatric rehabilitation and early interventions to promote health and competence in young children. Sharon Ramey is a Distinguished Scholar of Human Development at the Fralin Biomedical Research Institute at Virginia Tech, where she holds professorships in Psychology, Psychiatry and Behavioral Medicine, Neuroscience, and Human Development. Currently, she is lead Multiple PI for 3 NIH-funded multisite comparative efficacy (RCT) trials in pediatric neurorehabilitation: Sharon Ramey is an advocate for use of community-based participatory research as well as for Implementation Science trials to accelerate the high-fidelity, equitable application of newly discovered efficacious forms of rehabilitation to yield maximum benefits to patients and families.
Steven L. Wolf, Ph.D., PT, FAPTA, FAHA, FASNR, is a physical therapist and neuroscientist who has spent over 5 decades studying the development of novel interventions and the mechanisms underlying their utility for improving upper extremity function and gait among stroke survivors and postural control in older adults who experience frequent falls. He is a professor and Director of Research within the Department of Rehabilitation Medicine, Division of Physical Therapy and a professor in the Department of Medicine, Emory University School of Medicine. He also is an associate professor in the Department of Cell Biology and a professor of elder care in the School of Nursing. He is a senior scientist at the Atlanta VA Center for Visual and Neurocognitive Rehabilitation. Dr. Wolf has led numerous NIH funded clinical trials and laboratory-based studies. Among his accomplishments are studies that delineated inclusion criteria for constraint induced movement therapy in stroke that led to the EXCITE Trial and the use of Tai Chi to delay falls in older adults. He has received or contributed to over $80M in funding and has over 280 refereed publications.