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* Department of Psychology
Civitan International Research Center, University of Alabama, Birmingham, Alabama
Center for Health and Education, Georgetown University, Washington, District of Columbia
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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Methods. A randomized, controlled clinical trial of pediatric CI therapy in which 18 children with diagnosed hemiparesis associated with cerebral palsy (7–96 months old) were randomly assigned to receive either pediatric CI therapy or conventional treatment. Pediatric CI therapy involved promoting increased use of the more-affected arm and hand by intensive training (using shaping) of the more-impaired upper extremity for 6 hours/day for 21 consecutive days coupled with bivalved casting of the child’s less-affected upper extremity for that period. Children’s functional upper-extremity skills were assessed in the laboratory (blinded scoring) and at home (parent ratings) just prior, after, and 3 weeks posttreatment. Treated children were followed for 6 months.
Results. Children receiving pediatric CI therapy compared with controls acquired significantly more new classes of motoric skills (9.3 vs 2.2); demonstrated significant gains in the mean amount (2.1 vs 0.1) and quality (1.7 vs 0.3) of more-affected arm use at home; and in a laboratory motor function test displayed substantial improvement including increases in unprompted use of the more-affected upper extremity (52.1% vs 2.1% of items). Benefits were maintained over 6 months, with supplemental evidence of quality-of-life changes for many children.
Conclusion. Pediatric CI therapy produced major and sustained improvement in motoric function in the young children with hemiparesis in the study.
Key Words: hemiparesis • cerebral palsy • pediatric rehabilitation • pediatric CI therapy • learned nonuse • upper extremity • CI therapy
Abbreviations: CP, cerebral palsy • PT, physical therapy • OT, occupational therapy • CI, Constraint-Induced Movement • EIP, early-intervention program • EBS, Emerging Behaviors Scale • PMAL, Pediatric Motor Activity Log • TAUT, Toddler Arm Use Test • DASI-II, Developmental Activities Screening Inventory • ANCOVA, analysis of covariance • df, degrees of freedom • SD, standard deviation
Cerebral palsy (CP), defined broadly as "a nonprogressive motor impairment syndrome caused by a problem in the developing brain,"1 affects at least 2 in 1000 children in the United States and >1 million children under the age of 21 in the industrialized world.2–5 Children with hemiparesis or substantially greater deficit in 1 upper extremity than the other comprise a significantly large group of those with CP.5 There is some question as to the efficacy of current physical therapy (PT) and occupational therapy (OT) treatment approaches to CP,1,6–8 especially with regard to transfer-of-treatment effect to the life situation. Until recently, few major theoretical or therapeutic advances were available to provide a basis for the development of new interventions for children with CP. In 1995, however, it was suggested that a promising new therapy for adults with hemiparesis consequent to stroke, known as Constraint-Induced Movement (CI) therapy,9–14 offered a potentially efficacious approach to the treatment of juvenile hemiparesis.15 The CI therapy protocol stems directly from basic research with monkeys (summarized in refs. 9 and 16). The studies reporting positive treatment effects for this intervention in humans include 2 with placebo control groups10,14 and replications in other laboratories.17–19
The purpose of the present experiment was to carry out a randomized trial with a conventional physical rehabilitation control group to determine whether the full application of both components of the CI therapy protocol (extended, intensive training of the more-affected arm for many hours a day over a period of consecutive weeks and restraint of the less-affected arm for that period) would produce an improvement in motor function in young children with CP. A single case study has demonstrated positive changes in motor function of the more-involved arm.20
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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8 years old, and for children <18 months an etiology of stroke confirmed by magnetic resonance imaging findings. The University of Alabama Institutional Review Board approved the study protocol, and parents signed informed-consent statements. Children were assigned randomly to receive either pediatric CI therapy or conventional treatment. Randomness was achieved by assigning patients according to the group designation indicated on a folded piece of paper, taped closed, and drawn from a jar set up before the beginning of subject enrollment.
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The children in the control group continued their participation in previously established EIPs, which included receiving conventional PT and/or OT for a mean of 2.2 hours per week.
Assessments
Children were pretested after randomization into 1 of the above groups then posttested after treatment or an equivalent time period for controls, with follow-up testing 3 weeks later. In addition, the pediatric CI therapy group received 3- and 6-month follow-up testing. Measures included the Emerging Behaviors Scale (EBS), the Pediatric Motor Activity Log (PMAL), and blinded ratings of videotaped sessions of the Toddler Arm Use Test (TAUT). The EBS is a tool developed here to provide quantification for the observation in pilot work that children receiving pediatric CI therapy rapidly acquired entirely new, age-appropriate behaviors. The EBS provides systematic (rather than anecdotal) information about young children’s neuromotor repertoire, particularly regarding the onset of newly acquired behaviors of importance in young children’s lives that had not been observed before treatment by the principal caregiver, the therapist, or other sources (eg, child’s previous provider of physical rehabilitation services). The presence or absence of 31 motor patterns and functional activities are recorded, such as reaching, prehension of different types, carrying objects, releasing objects, individual finger use, weight bearing of different types, position transfer (eg, lie to sit, sit to crawl, and crawl to stand), mobility involving arm use, and hand gestures. Determination of the occurrence of the new classes of movement had to come from at least 2 of the following sources: a project therapist as recorded in the daily notes, the principal caregiver, a videotape of a treatment session, or occurrence and record of activity at a posttreatment testing session. The EBS score is the number of new behaviors that emerged after the beginning of treatment or the equivalent time point in control subjects.
The PMAL is a semistructured interview administered every other day to a child’s principal caregiver, which in the case of all subjects in this experiment was the mother. It obtains systematic data about 22 distinct arm-hand functional activities typical of young children. It is an adaptation of the Motor Activity Log developed for adult patients with stroke.10 The adult Motor Activity Log is psychometrically robust, yielding scores that remain stable during a 2-week period when either a placebo treatment14 or no treatment17 was administered. It has high internal consistency (Cronbach’s 
= .88 to .95), interrater reliability (patient compared with primary caregiver, Intra Class Correlation type 3, 1 = 90), and high test-retest reliability (r = .94; P < .01).14,17
The TAUT is a standardized laboratory motor test in which a series of 22 tasks/play activities are presented before treatment and after the less-impaired arm cast is removed after treatment. The examiner tries to elicit the child’s best effort to secure or activate a toy or perform a given task. If the child does not use the more-impaired arm or hand at first, then the child is asked to try the task with that arm/hand, restraining the less-impaired upper extremity if necessary. Videotapes of these sessions were scored independently by 2 experienced pediatric occupational therapists (interrater reliability = .98) who were blind to the treatment group and pre- or posttreatment status of the children. A list of test activities, the scoring format, and the scoring scales for both the PMAL and TAUT are contained in Appendices 1 and 2, respectively.
The Developmental Activities Screening Inventory (DASI-II) is an educational screening tool designed to help identify children at risk for educational delay at an early age.22
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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Adjustment to Long Arm Cast
During the casting session, children showed some temporary upset, particularly when the cast saw was used to bivalve the just-applied cast into 2 parts. Within 1 to 2 days, however, all children had adjusted very well to the presence of the cast. During the weekly removal of the cast, 4 of the 9 children had some mild skin redness, rash, or pinching, which was treated effectively with Neosporin and/or Band-Aids and the insertion of additional cotton wrap when reapplying the cast. No children resisted cast reapplication, and several specifically asked to have it put back on their arm.
Upper-Extremity Movement
Before analysis of posttreatment data, 1-way analyses of variance were conducted on pretreatment scores. These tests indicated that there were no preexisting differences between treatment groups on any of the measures.
On the EBS, the children in the pediatric CI therapy group exhibited a mean of 9.3 new motor patterns and classes of functional activity that they had never been observed to perform previously. This was greater by a factor of 4.3 than the 2.2 new motor behaviors the children in the control group acquired during the treatment period (Table 2). A repeated-measures analysis of covariance (ANCOVA) with pretreatment score as the covariate revealed a significant effect of treatment (F = 84.59; degrees of freedom [df] = 1; P < .0001). The distribution of individual child scores between groups was nonoverlapping, with a range of 7 to 12 newly acquired skills for CI therapy children and 0 to 6 for conventional treatment controls. In the pediatric CI therapy group, 5 of 9 children gained 
10 new upper-extremity skills; 5 of 9 control children gained 2.
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Children’s performance on the TAUT revealed large and statistically significant between-group differences after treatment in percent of items for which children used their more-impaired upper extremity without prompts, percent of items scored as successfully accomplished through use of the more-impaired arm, and overall quality of use of that extremity. Within each group, children receiving pediatric CI therapy increased first-time use of their more-impaired upper extremity from pre- to posttreatment by a mean of 53.9% (SD = 35.64), whereas controls increased by a mean of 18.00% (SD = 31.12). In addition, blinded ratings of overall independent functional use of the more-impaired arm showed a mean gain for the pediatric CI therapy group of 16.8% (SD = 21.53) compared with 5.0% (SD = 15.4) for the control group.
Follow-Up
Children in the pediatric CI therapy group maintained their treatment gains at 3 and 6 months follow-up. The children’s PMAL Amount of Use gain scores had means (SDs) of 1.3 (1.11) at 3 months and 1.6 (1.23) at 6 months, indicating a small but not statistically significant decline from 3-week posttreatment performance change (1.8). Quality of Movement means (SDs) were 1.7 (.83) and 1.8 (.61) at 3 and 6 months, respectively, essentially the same as at 3-week posttreatment (1.7 [.97]).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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Verbal descriptions by parents of major changes in quality of life and general development confirmed the more formal quantification of parental reports obtained on the PMAL. Several children began to crawl soon after treatment ended. One child who previously showed no awareness of his more-impaired extremity made large gains in all areas of development. He began to use all the muscles of his more-impaired side in coordinated fashion, started "commando" crawling, pivoted in prone, and pushed up on extended arms. Two children began to sit independently. A 41/2-year-boy who had never used his more-affected arm or hand began to play ball and, in 
6 months, realized his desires of being able to fish with his father and join a Little League Baseball team, batting with both hands and using a specially adapted glove on his more-impaired hand to keep it in place. An unanticipated change many parents reported was an increase in their children’s social and communication skills, often accompanied by signs of increased confidence and enjoyment in daily activities.
Two of the pediatric CI therapy subjects were 7 and 10 months of age, respectively. There can be some question concerning the accuracy of the diagnosis of CP at those ages. However, both children had experienced severe prenatal strokes, as revealed by marked clinical symptoms and confirmed by magnetic resonance imaging findings.
Three randomized, controlled trials testing the efficacy of widely used, professionally endorsed forms of physical rehabilitation failed to report significant benefits.23,24 Two other randomized trials showed possible and/or small-magnitude benefits,25,26 but methodological limitations render interpretation of their results problematic. In our study, treated children showed large and significant gains in both quality and amount of use of the more-impaired extremity. Our results also differ markedly from those of 4 studies in which restraint of the less-affected upper extremity alone was used for varying periods in children with hemiparesis without the intensive training component of pediatric CI therapy.27–30 Restraint alone was found to result in a modest to weak treatment effect that is only a portion of what was obtained in this study when both the restraint plus the training components of pediatric CI therapy were used. Although restraint alone is becoming increasingly popular, it would seem to be of limited value when not coupled with active training, as by a shaping technique. This is similar to the situation with adult patients with stroke in which restraint alone produces just 20% of the treatment effect obtained with the full protocol.14
The main therapeutic factor underlying the clinical efficacy of CI therapy is the concentrated extended nature of the training conducted for many hours daily over a period of consecutive weeks.12,14 A literature search did not reveal any report of a conventional pediatric (or adult) PT training procedure conducted at this level of intensity. Because research has shown that this is the critical parameter, it is likely that some conventional interventions would produce an enhanced effect with this schedule of delivery of services. This has been shown to be the case with adults for whom conventional PT procedures (combined neurotherapeutic facilitation, task practice, and aquatic therapy) given 5 hours/day for 2 weeks produced a very good clinical effect. However, this intense and atypical schedule of delivery of services would result in a therapy possessing the most important defining characteristic of CI therapy (ie, concentrated practice for an extended period).12,14 It is, of course, still possible that other new methodological characteristics introduced in CI therapy might confer an advantage on it in terms of treatment outcome.
Similar considerations arise with respect to the issue of whether the treatment effect observed here is merely the result of time spent in treatment and not the treatment itself. This issue was addressed in a study with adult patients with stroke from this institution in which it was found that a "general fitness" placebo control group shown by pretreatment questionnaire to be credible and involving the same amount of subject/therapist interaction as in a CI therapy group failed to show a meaningful treatment effect.12,14 There is little reason to believe that the situation would be different for children. It would be of value to examine both the question of nonspecific effects from pediatric CI therapy and the dose-response effect of the intensity of treatment in future research.
In adults, the efficacy of CI therapy is predicated on 2 linked but independent mechanisms: use-dependent cortical reorganization and overcoming learned nonuse. After stroke the cortical-representation zone of the more-affected upper extremity in the primary motor cortex contracts to approximately one-half the size of the motor-representation area in the less-affected hemisphere.31,32 CI therapy results in a doubling in the size of the cortical representation zone of the more-affected limb, which has the effect of equalizing the size of the motor output areas on both sides of the brain,31 as well as recruiting ipsilateral motor cortex into playing a major role in the innervation of the movements of the more-affected arm.33 As noted, the common factor in all forms of CI therapy, including its use with young children in this study, seems to be repeatedly practicing use of the more-affected upper extremity in concentrated fashion for many hours a day for a period of consecutive weeks. This factor is presumed likely to produce the large use-dependent cortical reorganization that has been observed and the long-term persistence of the CI therapy effect. It should be noted that this use-dependent brain plasticity effect provides support for the belief that the intensity of treatment, which increases the frequency of use of the more-affected arm, is a significant factor in producing the therapeutic result observed here. It also provides indirect support that the results observed here were not due to a placebo effect.
The learned nonuse mechanism, the experimental support of which is described in detail elsewhere,9,14,16 comes into operation as a result of the fact that substantial neurologic injury usually leads to depression in motor function that is considerably greater than will be the case after spontaneous recovery of function has taken place. The depressed responsivity of motoneurons leads to a reduced ability to move the more-affected limb in the early postinjury period. During the period of depressed neural function, the individual is either unable to move the more-affected limb or make more than clumsy, inefficient movements. The resulting motor failure results in suppression of future attempts to use the more-affected limb. At the same time, the individual learns to compensate by using only the uninvolved limb for most purposes. These efforts are at least partially effective, and the individual is consequently rewarded by this success. The result is that the individual learns not to try to use the more-affected limb, the use of which is then held in powerful inhibition. When appropriate techniques are applied, however, learned nonuse can be overcome. Two such techniques involve intensive training of the more-affected limb and restriction of the less-affected limb. Both procedures require use of the more-affected limb for normal activities, or the individual is either rendered virtually helpless or unable to carry out the required behavioral task.
In children who sustain central nervous system injury in the prenatal, perinatal, or early-postnatal periods, the situation differs in some ways. For these children, different classes of behavior fail to develop entirely. Thus, most of these children do not have the experience of performing motor activities that are later lost after a central nervous system injury, as in the case of adults after stroke. One might, therefore, more appropriately refer to "developmental disregard" in these children. However, the same mechanisms of punishment of ineffective, clumsy attempts to use the more-affected extremity and reward for at least partially successful use of the less-affected extremity alone are presumed to operate in young children as they do in individuals with a mature motor repertoire. Developmental disregard might then be viewed as a special case of learned nonuse.
In almost all the research using CI therapy with adults, an exclusion factor has been substantial cognitive deficit as indicated by a score of <24 on the Mini-Mental State Examination. Relatively few adult patients with stroke had to be excluded on this basis, and, within the limited range studied, no correlation was observed between score on the Mini-Mental State Examination and CI therapy outcome. In this study, children scoring >1 SD below the age norm on the DASI-II exhibited a significant treatment effect, but there was a trend for it to be less large than that for the above-norm subjects. However, because of the very small sample size (3 in each of the subgroups), one can consider this difference suggestive only, but a possible guide for future work.
CP in infants and children not only involves delays or permanent deficits in neuromotor function but also has a profound effect on other functional domains, including sensory awareness and responsiveness, and type and level of engagement with the physical and social environment. The consequences of major motor disabilities are profound for all aspects of a child’s quality of life.1,8 It would be of value to ascertain more systematically than we did the extent to which pediatric CI therapy also contributes to changes in other developmental domains, presumably by introducing new motor capabilities into the child’s behavioral repertoire and allowing the child to experience rapid gains. The parental reports and videotaped sessions indicate that many children receiving pediatric CI therapy increased their self-confidence, interacted more with their environment, and demonstrated new sensory awareness of the hemiparetic extremity. It remains for future research to evaluate these reports objectively.
An additional objective of future research would be to determine whether the results reported here can be replicated in other laboratories. It would also be important to determine whether casting the less-affected arm for 3 weeks results in any short-term or long-term loss of function in that extremity and, additionally, what the dose-response relationship is between treatment outcome and amount of both less-affected limb restraint and more-affected limb training. A major concern in the practitioner community is that there are strong pressures to recommend only the amount (intensity) of rehabilitation therapy for which health care payers are currently willing to reimburse. However, virtually all interventions for young children in which treatment is given on the present attenuated basis remained untested and unproven.34 In contrast, the data presented from this randomized, controlled trial of CI therapy indicate that a more-intensive schedule of delivery of pediatric rehabilitation services than is given conventionally can produce large, sustained gains. As in clinical research with adults, CI therapy in young children with hemiparesis leads to rapid and large changes in motoric function.
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APPENDIX I: PMAL |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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APPENDIX II: CHILD ARM USE TEST |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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Scoring Instructions
(Rated from videotape; raters were blinded to group and pre- or posttreatment status.)
Arm Selection
On unforced first attempt of each activity (both arms available for use), which arm was chosen?
R = Right arm L = Left Arm
Use the following scales to rate the child’s best effort with the more-involved arm.
Amount of Participation
0 Child does not attempt to use the more-involved arm.
1 Child moves more-involved arm during task, but it does not contribute to task completion.
2 Child uses more-involved arm to carry out the task regardless of whether the task was performed in an age-typical manner.
How-Well Scale
(Same as for PMAL)
Willingness Scale
0. Never attempted activity with more-involved arm.
1. Considerable resistance: pulled away or took an excessive amount of time to attempt with more-involved arm.
2. Some resistance: required a few prompts (tapping or cueing the more-involved arm) or needed less-involved arm restrained.
3. No resistance: attempted activity with more-involved arm with minimal prompting.
Global Rating
Rate your overall reaction to the child’s ability to utilize the more-involved arm, with 0 being no ability and 10 being age-typical ability.
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GLUE BOYS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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Wax E. A generation orphaned by AIDS. Washington Post Weekly. October 27–November 2, 2003
Submitted by Student
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ACKNOWLEDGMENTS |
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We are grateful to Mary-Rebekah Trucks, Bonnie Rose, Anna Hart, Tina Mull, and Sonya Pearson, who provided the pediatric CI therapy to the children; Dr Laura Vogtle, Jan Rowe, and Pam Bruner, who conducted the expert testing and rating of children; Dr Charles Law for casting procedures; and Dr Alan Percy for careful reading of the manuscript. We are also appreciative of the assistance of Shobrena Shamburger and Angela Matthews with manuscript preparation, and we thank the Service Guild Early Intervention Program of Birmingham for providing testing and treatment space.
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FOOTNOTES |
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Address correspondence to Edward Taub, PhD, Department of Psychology, University of Alabama, CPM 712, 1530 3rd Ave South, Birmingham, AL 35294-0018. E-mail: etaub{at}uab.edu
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REFERENCES |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONAPPENDIX I: PMALAPPENDIX II: CHILD ARM...GLUE BOYSREFERENCES |
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