Efficacy of a childfriendly. constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial

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1 Efficacy of a childfriendly form of constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial Jeanne R Charles PhD MSW PT, Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY; Steven L Wolf PhD PT FAPTA, Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, GA; Jennifer A Schneider BA, Department of Biobehavioral Sciences, Teachers College, Columbia University; Andrew M Gordon* PhD, Department of Biobehavioral Sciences, Teachers College; and Department of Rehabilitation Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA. *Correspondence to last author at Department of Biobehavioral Sciences, Box 199, Teachers College, Columbia University, 525 West 120th Street, New York, NY 10027, USA. Constraint-induced (CI) movement therapy is a promising therapy for improving upper limb function in adults after stroke. It involves restraint of the non-involved limb and extensive movement practice with the involved limb. In this study, a single-blinded, randomized, control study was performed to examine the efficacy of CI therapy, modified to be child friendly, in children with hemiplegic cerebral palsy (CP). Twenty-two children (8 females, 14 males; mean age 6y 8mo [SD 1y 4mo]; range 4 8y) were randomized to either an intervention group (n=11) or a delayed treatment control group (n=11). Children wore a sling on their non-involved upper limb for 6 hours per day for 10 out of 12 consecutive days and were engaged in play and functional activities. Children in the treatment group demonstrated improved movement efficiency and dexterity of the involved upper extremity, which were sustained through the 6-month evaluation period, as measured by the Jebsen Taylor Test of Hand Function and fine motorsubtests of the Bruininks Oseretsky Test of Motor Proficiency (p<0.05 in both cases). Initial severity of hand impairment and testing compliance were strong predictors of improvement. Caregivers reported significant increases in involved limb frequency of use and quality of movement. However, there was no change in strength, sensibility, or muscle tone (p>0.05 in all cases). Results suggest that for a carefully selected subgroup of children with hemiplegic CP, CI therapy modified to be childfriendly, appears to be efficacious in improving movement efficiency of the involved upper extremity. Children with hemiplegic cerebral palsy (CP) usually have difficulties with reaching and grasping with the involved upper extremity (e.g. Eliasson et al. 1991, Gordon and Duff 1999, Steenbergen and Van der Kamp 2004). They often learn to perform many tasks exclusively with their non-involved extremity. This results in failure to use the involved extremity (i.e. developmental disuse; Gordon et al. 2005). Previously we have shown that repetitive practice of a grasping task with the involved hand can result in improved performance (Gordon and Duff 1999, Duff and Gordon 2003). This finding suggests that intensive practice may improve hand function. A recently developed therapeutic intervention, constraintinduced (CI) movement therapy, may be beneficial in improving hand function as it provides the opportunity for intense practice with the involved upper extremity as a result of restraining the non-involved extremity. Early studies in adults with hemiplegia examined the effects of forced use (restraint without structured practice) on the involved upper extremity (e.g. Wolf et al. 1989). Subsequent studies involving adults affected by stroke used structured practice (including the essential elements of shaping and repetitive practice) in addition to restraint. This intervention was further refined and termed CI therapy (Taub and Wolf 1997; see Wolf et al for review). Currently there is an ongoing multisite trial (the Extremity Constraint-induced Therapy Evaluation [EXCITE]) testing the efficacy of CI therapy for people with sub-acute stroke (Winstein et al. 2003). Fifteen studies have been published so far that have examined the efficacy of either forced-use or CI therapy in children (age range 12mo 17y; see Charles and Gordon 2005 for review). Many of these have been case studies, often using qualitative outcome measures, with only six of the 15 studies being larger ABA, ABAA, or randomized control trials (Willis et al. 2002; Eliasson et al. 2003, 2005; Taub et al. 2004; Naylor and Bower 2005; Gordon et al. 2006). Of these, only Taub et al. (2004) and Eliasson et al. (2005) were blinded, randomized studies. All of the studies reported positive results, thus suggesting that CI therapy and forced-use may be beneficial. However, the studies all differed in methodology and outcome measures, many of which were not standardized or objective. Thus, more comprehensive and systematic studies of the parameters of this intervention (using a child-friendly methodology) need to be conducted. The purpose of the present study was to examine the efficacy of a modified form of CI therapy (Gordon et al. 2005) on involved upper extremity function in children with hemiplegic CP. An attempt was made to improve on the methods used in earlier pediatric CI therapy and forced-use studies, including our own (Charles et al. 2001). The study was designed to be aligned as closely as possible with the methodology employed in the EXCITE trial (Winstein et al. 2003) by maintaining the two major elements of adult CI therapy (repetitive practice and shaping), yet be as child friendly as possible by incorporating movements in the context of games or age-appropriate functional tasks. We examined the efficacy of this intervention by selecting outcome measures that would provide information at three levels: (1) movement efficiency and functional limitations (standardized and criterion referenced tests of upper extremity and hand function); (2) environmental functional limitations (caregiver report); and (3) impairment (clinical tests of sensibility, strength, and muscle tone). Developmental Medicine & Child Neurology 2006, 48:

2 Method PARTICIPANTS AND RECRUITMENT The following inclusion criteria were established based on those used in the CI therapy studies on adults with stroke (Winstein et al. 2003) and prior studies with young children (e.g. Charles et al. 2001, Gordon et al. 2005): (1) ability to extend the wrist at least 20 and the fingers at least 10 from full flexion at the metacarpophalangeal joints; (2) a 50% difference between the involved and non-involved hand on the Jebsen Taylor Test of Hand Function (Jebsen et al. 1969) provided twice during screening; (3) scored within 1SD of the mean on the Kaufman Brief Intelligence Test (Kaufman and Kaufman 1990); and (4) willingness to agree to intervention and testing procedures and travel to Columbia University for participation. Children were excluded who had: (1) health problems not associated with CP; (2) seizures; (3) visual problems that would interfere with carrying out the intervention or testing; (4) severely increased muscle tone (modified Ashworth score greater than 3; Bohannon and Smith 1987); (5) orthopedic surgery on their involved upper extremity; (6) dorsal rhizotomy; (7) botulinum toxin therapy in the upper extremity musculature during the past 6 months or who wished to receive it within the period of study; (8) intrathecal baclofen; and (9) balance problems while wearing the sling. Participants were recruited from the greater New York City metropolitan area and through announcements on various electronic bulletin boards and our website: Ninety children with hemiplegic CP (age range 4 8y; Fig. 1) were initially screened by telephone to determine age, diagnosis, pertinent medical history, and the frequency and duration of current physical and occupational therapy services. On the basis of the telephone interviews, 57 children did not meet inclusion criteria. Of the 42 remaining children, 33 met criteria for inclusion after further screening and were recruited into the study (see Fig. 1 legend for details). Randomization was performed in groups of four children (i.e. rolling admission) with the intention to achieve an equal number (n=11) in both the treatment and control groups; dropouts were replaced immediately. Twenty-two children (8 females, 14 males; mean age 6y 8mo [SD 1y 4mo]; range 4 8 years; Table I) completed the study, including all posttest evaluations. All children demonstrated moderate hand involvement (type IIa; Zancolli and Zancolli 1981). Children in the control group did not receive any treatment. They were offered the opportunity to be crossed-over to receive treatment after their participation. Children in both groups continued to receive the usual and customary care that they were receiving elsewhere. Informed consent was obtained from all children and their caregivers. Each child received US$50 for participation. The study was approved by Teachers College, Columbia University Institutional Review Board. PROCEDURES CI therapy The intervention (described in detail in Gordon et al. [2005]) was provided on 10 out of 12 consecutive days during summer or school vacations (typically 2 weeks of weekdays) at Columbia University with groups of two to four children. Children in the treatment group wore a sling on the Allocated to intervention (n=19) Did not receive intervention (n=3) Participation too much commitment (n=2) Unable to tolerate intervention (n=1) Lost to follow-up (n=5) Participation too much commitment (n=2) Did not keep evaluation appointments (n=1) Did not cooperate during evaluation (n=2) Assessed for eligibility,(n=90) Randomized (n=33) Did not meet inclusion criteria (n=57) Allocated to control group (n=14) Participation involved too much commitment (n=1) Lost to follow-up (n=2) Did not complete evaluation (n=1) Did not complete evaluation/participation involved too much commitment (n=1) Figure 1: Progress through stages of constraint-induced (CI) therapy study, including flow of participants, withdrawals, and inclusion in analyses. Fifty-seven out of 90 potential participants did not meet inclusion criteria. Of these, 48 potential participants did not qualify as determined by telephone interview. Reasons were: not interested or able to commit to study procedures or travel to Columbia University for evaluation and/or intervention (n=20); too young (n=14); did not have hemiplegic cerebral palsy (n=8); had visual impairment (n=4); and had undergone hand surgery (n=2). Nine additional participants were excluded after subsequent home screening. Reasons were: hand impairment too severe (<20 wrist extension; n=5); hand impairment too mild (<50% difference between two hands; n=3); and cognitive status (n=1). Randomized to study (n=33): CI intervention group (n=19), with three participants not completing intervention (two withdrawing before receiving intervention, and one child was removed from intervention because interventionists felt she was unable to tolerate procedure), control group (n=14), and one control participant declining participation. Lost to follow-up: intervention group (n=5), control group (n=2). Analyzed: intervention group (n=11), control group (n=11). Analyzed (n=11) Analyzed (n=11) 636 Developmental Medicine & Child Neurology 2006, 48:

3 non-involved upper extremity for the entire time during an intervention session (6h) and the sling was removed at the end of each session. The sling was strapped to the child s trunk and the distal end was sewn shut to prevent use of the non-involved hand. Time out of the sling during the 6-hour period was allowed for designated activities (e.g. toileting) and could not exceed 30 minutes per day. At the end of each day, each child in the treatment group went home with an exercise program that involved practice with the involved extremity (without any restraint) for 1 hour, which was extended to 2 hours per day for 6 months after the intervention. Parents kept activity logs to monitor compliance. During each 6-hour session each child received individualized instruction from a trained interventionist involving specific practice of designated target movements. Children were engaged in play and functional activities that provided two types of structured practice (shaping and repetitive task practice) using the involved upper extremity, especially the hand. Shaping involved practicing a target movement in isolation of other movements under a time constraint of 30 seconds (e.g. practicing wrist supination by turning over as many cards as possible in 30s). As soon as the target movement was performed successfully, the difficulty of the task was increased by changing either temporal or spatial/accuracy task constraints (e.g. changing the position of the cards from midline to the contralateral side). Success was defined as achieving either the same or increasing frequency in three out of five consecutive trials. The choice of changing either spatial/accuracy or temporal constraints was dependent on the constraints of a particular task and the target movements that were elicited by the task. Repetitive task practice involved performing a target movement in a functional context or in relation to other movements (i.e. practicing forearm supination by turning over cards within the context of a game). None of the tasks tested in the outcome measures was practiced during the intervention. Total time spent performing task activities, as well as the time spent in shaping and repetitive task practice, were recorded as a measure of dosing. Children were given positive verbal reinforcement throughout a task for performance of target movements. MEASUREMENT Outcome measures were selected that would provide information at three levels. To assess upper extremity efficiency, the Jebsen Taylor Test of Hand Function (Jebsen et al. 1969) was used, and this measure served as the primary outcome measure. The Jebsen Taylor test was modified by eliminating the writing task and capping the maximum allowable time to complete each of the six timed items at 2 minutes, to reduce frustration levels associated with failure to accomplish the task. Thus, the maximum time to complete all items was 720 seconds. We also used subtest 8 (speed and dexterity) of the Bruininks Oseretsky Test of Motor Proficiency (Bruininks 1978), which consisted of unimanual and bimanual items (unimanual items performed with the involved extremity). Both tests were videotaped for additional analyses. At the environmental level, a Caregiver Functional Use Survey (CFUS) was designed to assess caregivers perceptions of how much and how well their child used the involved upper extremity (Appendix I). Fourteen bimanual items were rated on a 6-point Likert scale on the frequency and quality of hand use. The following tests were used at the impairment level: sensibility was measured with two-point discrimination (TPD); hand-grip strength was measured using a hand-held dynamometer; the modified Ashworth scale was used to assess muscle tone. Table I: Data on treatment and control participants Child Group Involved side Sex Age (y:m) Jebsen pretest score (s) TPD (mm) Muscle tone (S/E/W) 1 Treatment L F 7:5 720 NR 0/1/2 2 Treatment L F 7: /3/2 3 Treatment L M 7: /1/1 4 Treatment R M 4:7 325 NR 0/1/0 5 Treatment L F 7: /1/1 6 Treatment L F 5: /1+/1 7 Treatment L F 7: /1/1 8 Treatment R M 7: /2/1+ 9 Treatment R F 6: /1/1 10 Treatment L M 7: /1/1+ 11 Treatment L M 4: /1/1 12 Control R M 5: /1/0 13 Control L F 4:5 510 NR 2/3/3 14 Control R M 6:6 468 NR 1+/2/1 15 Control L M 6: NR 0/0/2 16 Control R M 5:5 339 NR 0/1/1 17 Control R M 8: /0/0 18 Control R F 6:0 206 NR 1/1+/2 19 Control R M 6: /3/0 20 Control L M 5: /1/1+ 21 Control L M 8: /1/0 22 Control R M 8: /1/1 Participants are listed in descending order based on Jebsen Taylor Test of Hand Function (Jebsen et al. 1969) times at pretest. TPD, two-point discrimination; S, shoulder; E, elbow; W, wrist; L, left; R, right; F, female; M, male; NR, not reliable, muscle tone determined by modified Ashworth scale (0 4). Child-friendly Constraint-induced Therapy Jeanne R Charles et al. 637

4 Each participant was evaluated once before (pretest) and three times after the intervention at 1 week (posttest) and at 1 and 6 months (follow-up sessions). The same evaluator, blind as to group assignment, performed all testing of a specific child. A total of five evaluators were used over the course of this study. Each evaluator received 20 hours of training to assure consistency and establish reliability; all evaluators remained successfully blinded to group assignment for the duration of the study. Intra- and interrater reliability were measured (Jebsen Taylor Test: intrarater reliability 0.99, interrater reliability 0.99; Bruininks Oseretsky Test: intrarater reliability 1.0, interrater reliability 0.94). STATISTICAL ANALYSIS We were interested in both the changes in involved extremity function immediately after the intervention and whether these changes were retained subsequently. Thus, a 2(groups) 2(sessions; pretest vs posttest) analysis of variance (ANOVA) with repeated measure on the second factor was used to evaluate differences for each measure immediately after the intervention. A 2(groups) 3(sessions; posttest vs subsequent two posttests) repeated measures ANOVA was used to evaluate whether changes evidenced on the posttest were retained. An overall group testing session interaction tested whether the average time course differed between groups. This approach effectively controls for differences at baseline between the two groups. Tests of simple effects were used for post hoc analysis. We also performed these tests on log-transformed data and performed non-parametric statistics, with the same qualitative results. Regression analysis was used to determine the relation between practice intensity, behavior during the intervention session, and severity of hand function to both absolute and percent changes (because the baseline values differed among the children) in the Jebsen Taylor Test of Hand Function from the preintervention to the 1-week postintervention testing session. Practice intensity was determined by the total time on task data for each child during the intervention and the time each child practiced at home during the intervention. The Jebsen score obtained during screening was used as a measure of severity of involved hand function (they were not significantly different from the pretest scores). Behavior (disruptive, non-complaint, inattentive, based upon predetermined definitions) was assessed through a review of videotapes of each testing session. Three evaluators reviewed these tapes and, as a group, categorized and defined those behaviors exhibited on the tapes that necessitated redirecting a child s efforts. A blinded evaluator then recorded the number of disruptive, non-compliant, and inattentive behaviors displayed by each child during each evaluation session. The frequency of these behaviors was used as a predictor of how well a child attended to task during testing and throughout the intervention. Results TREATMENT INTENSITY Overall, children in the treatment group spent a mean of 58% (35/60h, range 20 50h) of the time during the intervention in structured practice. Of this time, 33% was spent in shaping practice and 67% in repetitive task practice. The remaining time in which children were not in structured practice was spent choosing activities, transitioning between tasks, and toileting, etc. None of the children was out of their sling for more than 15 minutes during any 6-hour session. In addition, the children used their involved upper extremity in home practice for an average of 5.7 hours per 10 days during the intervention and 7.3 hours per week for 6 months after the intervention Time (s) CI therapy Control 200 Pretest 1wk 1mo 6mo Posttest Follow-up sessions Time (s) Pretest 1wk 1mo 6mo Posttest Follow-up sessions Figure 2: Mean (SEM) time to complete six timed items (writing excluded) of Jebsen Taylor Test of Hand Function for constraint-induced (CI) therapy (solid line; n=11) and control (dashed line; n=11) groups at each testing session. Faster times correspond to better performance. Maximum allowable time to complete each item was capped at 120s, resulting in maximum score of 720s. Child 1 Child 2 Child 3 Child 4 Child 5 Child 6 Child 7 Child 8 Child 9 Child 10 Child 11 Figure 3: Time to complete six timed items (writing excluded) of Jebsen Taylor Test of Hand Function for each participant in constraint-induced intervention group (n=11) at each testing session. Faster times correspond to better performance. Note that children with slower times at pretest generally improve less than children with lower scores. 638 Developmental Medicine & Child Neurology 2006, 48:

5 CHANGES IN MOVEMENT EFFICIENCY As shown in Figure 2, the pretest scores for the Jebsen Taylor Test of Hand Function (the primary outcome measure) were higher for the intervention group (but p>0.05). Children in both groups improved (main effect, F[1,20]=17.414, p<0.001, effect size [η 2 ]=0.465), but children in the intervention group improved more than children in the control group on this measure 1 week after the intervention (group testing session interaction, F[1,20]=9.180, p<0.01, η 2 =0.315). Figure 2 displays individual subject scores for children in the treatment group where improvement from pretest to the first posttest was seen in nine out of 11 children, whereas two of three children with the worst initial scores on this measure (child 1 and 3) did not improve. Figure 3 also demonstrates that the decrease in time for the intervention group was maintained over the 6-month follow-up period. The control group decreased their time at the 1-month testing session but returned to the pretest time by the 6-month testing session. From the 1 week posttest onwards, there was no significant main effect within participants or of groups and no significant group by testing session interaction (p>0.05 in all cases), although it should be noted that the treatment group was slightly slower at the pretest and slightly faster at the 6- month posttest (but p>0.05). Although both groups showed improvements in speed and dexterity in the involved hand as measured by the Bruininks Oseretsky Test (main effect, F[1,20]=24.725, p<0.001, η 2 =0.553), children who received the intervention improved more after the intervention as compared with children in the control group (group testing session interaction F[1,20]=13.207, p<0.005, η 2 =0.399; Table II). Improvement was seen in all 11 children. Although the intervention group s score decreased between the 1-month and 6-month follow-up, it remained higher than at the pretesting session. In comparison, the control group s scores continued to improve slightly from the 1-month to the 6-month follow-up session. However, for the 1-week to 6-month follow-up, there was no significant main effect within participants across testing sessions or a Table II: Results (mean [SD]) for each outcome measure Pretest 1wk posttest 1mo posttest 6mo posttest Jebsen Treatment group (205.4) a (240.6) (238.0) (236.6) Control group (177.5) (182.2) (153.0) (200.0) Control after treatment b (196.7) (214.8) (215.0) (237.9) Bruininks Treatment group 4.8 (3.0) a 7.2 (2.9) 7.6 (4.4) 6.9 (3.7) Control group 4.8 (3.7) 5.2 (4.2) 5.5 (4.1) 6.3 (5.1) Control after treatment b 6.5 (5.2) 7.7 (6.0) 7.2 (5.8) 7.9 (6.4) CFUS (how frequently) Treatment group 2.6 (0.7) a 3.0 (0.7) 3.3 (0.8) 3.3 (0.9) Control group 2.6 (0.6) 2.3 (0.5) 2.5 (0.4) 2.6 (0.5) Control after treatment b 2.8 (0.6) 2.7 (0.6) 3.0 (0.5) 2.9 (0.9) CFUS (how well) Treatment group 2.0 (0.5) 2.5 (0.6) 3.0 (0.6) 2.9 (0.8) Control group 2.2 (0.5) 2.4 (0.4) 2.3 (0.3) 2.3 (0.5) Control after treatment b 2.6 (0.5) 2.7 (0.4) 2.8 (0.5) 2.9 (0.7) Grasp strength Treatment group 2.1 (2.0) 2.0 (1.6) 1.9 (1.4) 2.4 (1.8) Control group 2.2 (2.4) 2.1 (2.6) 2.9 (3.1) 1.8 (2.4) Control after treatment b 1.9 (2.5) 2.3 (2.4) 2.0 (2.2) 2.7 (2.7) Two-point discrimination Treatment group 7.5 (3.1) 6.6 (3.6) 6.5 (3.3) 7.6 (4.0) Control group c 5.7 (3.2) 4.4 (2.2) 4.6 (2.0) 5.7 (1.8) Control after treatment c 5.3 (2.0) 5.0 (2.6) 5.8 (3.9) 4.0 (1.7) Muscle tone (shoulder) Treatment group 0.5 (0.5) 0.1 (0.3) 0.4 (0.5) 0.2 (0.4) Control group 0.9 (0.8) 0.9 (0.6) 0.7 (0.5) 0.8 (0.6) Control after treatment b 0.9 (0.6) 0.3 (0.5) 0.5 (0.5) 0.9 (0.8) Muscle tone (elbow) Treatment group 1.3 (0.6) 1.1 (0.6) 1.2 (0.5) 1.1 (0.7) Control group 1.3 (1.0) 1.1 (0.8) 1.1 (0.8) 1.4 (0.6) Control after treatment b 1.6 (0.4) 1.3 (0.8) 1.6 (0.3) 1.5 (0.6) Muscle tone (wrist) Treatment group 1.2 (0.6) 1.2 (0.5) 1.3 (0.6) 1.2 (0.9) Control group 1.1 (1.0) 1.5 (0.8) 1.4 (0.5) 1.6 (0.7) Control after treatment b 1.5 (0.6) 1.2 (0.6) 1.7 (0.3) 1.9 (0.8) a p<0.05 for group testing session interaction. Jebsen, Jebsen Taylor Test of Hand Function (Jebsen et al. 1969); Bruininks Oseretsky Test of Motor Proficiency (Bruininks 1978); b n=10 for control group after treatment, n=9 for 6 month posttest; c n=7 for control group, n=6 for control group after treatment (n=5 for 6-mo follow-up) because we were unable to reliably test 2-point discrimination test in four children. CFUS, Caregiver Functional Use Survey. Child-friendly Constraint-induced Therapy Jeanne R Charles et al. 639

6 main effect of group and no significant group by testing session interaction (p>0.05 in all cases). CHANGES IN ENVIRONMENTAL (OR FUNCTIONAL) USE Caregivers of children in the intervention group perceived greater improvement in frequency of use than caregivers of children in the control group, as measured by the CFUS (Table II). Although there was not a main effect of time (p>0.05), children in the intervention groups frequency of use scores increased from pretest to posttest, whereas the control group scores decreased (group testing session interaction, F[1,20]=7.096 p<0.01, η 2 =0.262). From the posttest to 6-month follow-up both groups improved (main effect of group F[2.40]=8.653, p<0.01, η 2 =0.302). Caregivers of children in both groups also noted a change in quality of movement (main effect, F[1, 20]=7.995, p<0.01, η 2 =0.285) but the differences between groups were not evident at 1 week after the intervention. However, during the 1-month and 6-month follow-up sessions, the intervention group continued to improve whereas scores of the control group decreased (main effect of group F[1, 20]=4.773, p<0.05, η 2 =0.193; testing session by group interaction F[2,40]=4.89, p<0.01, η 2 =0.197). IMPAIRMENT LEVEL Scores for 2-point discrimination, hand-grip strength, and the Ashworth scale were not statistically different across any of the testing sessions (p>0.05 in all cases; Table II). PREDICTORS OF INCREASED MOVEMENT EFFICIENCY Behavior (r= 0.754) and severity (r= 0.633; Fig. 2) were both significantly related to percentage of improvement in Jebsen Taylor scores from pre- to postintervention, whereas intensity of treatment (r= 0.008) was not. Together, severity and behavior accounted for 73.5% of the variance in percentage of improvement (62% for absolute improvement; p<0.005). Neither compliance with home exercise nor any other factor significantly predicted changes in scores (p>0.05). CROSSOVER GROUP Ten of the 11 children from the control group chose to receive the intervention after they were tested on the same evaluation schedule as children in the treatment group (n=9 at 6-mo follow-up). Interestingly, unlike children in the treatment group, there was no improvement in the involved hand and arm immediately after the intervention for any measure (p>0.05 in all cases; Table II). There was no difference in number of redirections, intensity, or severity between the treatment group and the crossover/control group. Discussion This randomized control trial represents the most comprehensive study of CI therapy in children with hemiplegia to date. Results suggest that for a carefully selected subgroup of children with hemiplegic CP, CI therapy improved movement efficiency, performance, and perceived usage. The effect sizes were robust and the changes were retained up to 6 months after the intervention. EFFECTS OF INTENSIVE PRACTICE ON UPPER EXTREMITY FUNCTION Results of the Jebsen Taylor and Bruininks Oseretsky tests indicate improved unilateral movement efficiency and motor performance. At an environmental level (CFUS; see Appendix I) the perceived frequency and quality of use of the involved extremity improved from pre- to immediate postintervention. Because the CFUS consisted of bimanual tasks, the results suggest that there was a transfer to bimanual function. However, this measure has not been validated and, thus, needs to be interpreted cautiously. Involved upper extremity impairment did not change across testing sessions. This suggests that changes in motor performance and function were not related to these deficits (i.e. functional improvement can occur without changes in impairments), and challenges premises underlying traditional neurofacilitation techniques commonly used in treatment of children with neurological deficits. The results also suggest that intensity of treatment need not be as high as that provided in adult studies, where the restraint is also worn at home (see Wolf et al for review), and periods of intense structured practice may be more important than the duration of restraint wear. Children in this study received 60 hours of CI therapy. However, only 58% of that time on average was spent performing tasks. Because this time also included pauses between movements, taking turns in games with the interventionists or other children, or being redirected to the task, the intensity was even lower. However, it was also supplemented with several hours of home practice without a restraint. Although prior studies of CI therapy in children reported positive results, many were case studies. So far there have only been two other blinded, randomized, control studies of CI therapy in children with hemiplegia (Taub et al. 2004, Eliasson et al. 2005). Taub s study involved restraining children in casts for 24 hours per day for 1 month, with and without structured practice. Our study, as well as Eliasson s, succeeded in being child friendly by reducing the number of hours that children were restrained while still improving motor performance in the involved hand and embedding practice in play activities. Improvement in motor performance was related to severity of hand function. This, with the frequency of redirective behavior exhibited by children during the testing sessions, strongly predicted improvement. The relation between hand severity and improvement after the intervention is interesting because we excluded children whose hand function was very mild or severe. Eliasson et al. (2005) showed that children who initially use their involved hand less effectively during bimanual tasks improve more than children who use it more effectively. This may at first seem contradictory to our results; however, our finding was related to unimanual hand performance whereas theirs was related to bimanual task performance. In fact, in our study, when the initial CFUS (bimanual) frequency of use score is correlated to change in this measure from pretest to posttest, we also see a significant reverse relation (r= 0.70). Thus, unimanual function and bimanual use may be affected differently. The frequency of redirected behavior, a surrogate for attention, might relate inversely to the actual intensity received during the intervention. However, it could also indicate that we did not capture the children s best possible motor performance because performance may be related to their ability to attend to the test items. Oddly, contact time and home practice were not significantly related to improvement or retention of motor performance. Although the intervention intensity for all children may have exceeded a critical dose response, accurately establishing whether a relation 640 Developmental Medicine & Child Neurology 2006, 48:

7 between treatment intensity and outcome exists in this study may not be possible because pauses between movements and redirective behaviors were not quantified. Surprisingly, the children in the control group who subsequently received the intervention did not demonstrate improvement after they received the intervention. There was no difference between the pretest and 6-month follow-up scores for this group before crossover, so a ceiling effect is unlikely. Having been in the laboratory before participating in the intervention may have made them overly familiar with the environment and tasks, affecting their motivation; i.e. we may have not captured their true abilities after crossover. CI THERAPY IN CONSIDERATION OF NEURODEVELOPMENT Recent studies have begun to define critical periods in early human development when neuron circuits can be shaped by experience (Eyre 2003, Hensch 2004). Development of the corticospinal tract (CST) subserving distal extremity control has been found to be dependent on motor activity during a key critical period in developing kittens, and blocking the activity (or limb use) permanently prohibits appropriate termination of CST in the spinal cord and impairs motor behavior (see, for example, Martin et al. 2004). Thus, promoting early use may enhance the development of the CST, and, thereby, optimize developmental motor skill potential. Conversely, restricting movement or motor activity during such a critical period may have the opposite effect (see Martin et al. 2004). Although the extent to which such critical periods exist in humans is not known, CST connections do continue to develop during the first years of life and maturation is not complete until after 13 years of age (see Nezu et al. 1997). Thus, restricting movement of the non-involved limb for long periods of time (such as with casting) could potentially lead to adverse repercussions for the development of motor skills. Therefore, a better understanding of critical periods underlying human CST development is needed before longterm restraint should be provided. Several studies in rats after postnatal unilateral damage to the motor cortex have shown emergence of ipsilateral control, which suggests that there is early neural reorganization that results in corticospinal control of both limbs from the non-damaged hemisphere (see Gonzalez et al. 2004). There may be similar neural reorganization after early CNS damage (see Carr et al. 1993, Eyre 2003). Thus, cortical reorganization after CI therapy may be restricted to the ipsilateral hemisphere (Ueki et al. 2005), and may limit recovery. CLINICAL IMPLICATIONS Overall, this intervention improved involved upper extremity hand and arm function in a select group of children with hemiplegic CP. Provision of this intervention in a group setting may be advantageous because interactions between children were supportive and competitive. However, this intervention may not be advisable for all children with hemiplegia. The child s age and severity of hand function need to be considered. Determining whether forced-use is more appropriate for some ages and CI therapy more appropriate for others, as well as seeking the optimal dosage response and potential side effects, is also important. Finally, the transfer to bimanual tasks begs the question of whether similar intensive practice can be elicited without the restraint and whether this might result in even better functional outcome. DOI: /S Accepted for publication 14th February Acknowledgements This project was supported by NIH grant HD from the National Center for Medical Rehabilitation Research (National Institute of Child Health and Human Development). We thank the numerous volunteer interventionists, evaluators, and the children and families who participated in the study. We also thank Dr Stephen Silverman and Dr Ann Gentile for comments throughout the project. References Bohannon RW, Smith MB. (1987) Inter-rater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 67: Bruininks RH. (1978) Bruininks Oseretsky Test of Motor Proficiency. Circle Pines, MN: American Guidance Service. Carr LJ, Harrison LM, Evans AL, Stephens JA. (1993) Patterns of central motor reorganization in hemiplegic cerebral palsy. Brain 116: Charles J, Gordon AM. (2005) A critical review of constraint-induced movement therapy and forced use in children with hemiplegia. Neural Plast 12: Charles J, Lavinder G, Gordon AM. (2001) The effects of constraintinduced therapy on hand function in children with hemiplegic cerebral palsy. Pediatr Phys Ther 13: Duff SV, Gordon AM. (2003) Learning of grasp control in children with hemiplegic cerebral palsy. Dev Med Child Neurol 45: Eliasson AC, Bonnier B, Krumlinde-Sundholm L. (2003) Clinical experience of constraint-induced movement therapy in adolescents with hemiplegic cerebral palsy: a day camp model. Dev Med Child Neurol 45: Eliasson AC, Gordon AM, Forssberg H. (1991) Basic coordination of manipulative forces in children with cerebral palsy. Dev Med Child Neurol 33: Eliasson AC, Krumlinde-Sundholm L, Shaw K, Wang C. (2005) Effects of constraint-induced movement therapy in young children with hemiplegic cerebral palsy: an adapted model. Dev Med Child Neurol 47: Eyre JA. (2003) Development and plasticity of the corticospinal system in man. Neural Plast 10: Gonzalez CL, Gharbawie OA, Williams PT, Kleim JA, Kolb B, Whishaw IQ. (2004) Evidence for bilateral control of skilled movements: ipsilateral skilled forelimb reaching deficits and functional recovery in rats follow motor cortex and lateral frontal cortex lesions. Eur J Neurosci 20: Gordon AM, Charles J, Wolf SL. (2005) Methods of constraint-induced movement therapy for children with hemiplegic cerebral palsy: development of a child-friendly intervention for improving upper extremity function. Arch Phys Med Rehab 86: Gordon AM, Charles J, Wolf SL. (2006) Efficacy of constraintinduced movement therapy on involved-upper extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics 117: e Gordon AM, Duff SV. (1999) Fingertip forces in children with hemiplegic cerebral palsy. I: anticipatory scaling. Dev Med Child Neurol 41: Hensch TK. (2004) Critical period regulation. Annu Rev Neurosci 27: Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. (1969) An objective and standardized test of hand function. Archiv Phys Med Rehab 50: Kaufman AS, Kaufman NL. (1990) Kaufman Brief Intelligence Test. Circle Pines, MN: American Guidance Service. Martin JH, Choy M, Pullman S, Meng Z. (2004) Corticospinal system development depends on motor experience. J Neurosci 24: Naylor CE, Bower E. (2005) Modified constraint-induced movement therapy for young children with hemiplegic cerebral palsy: a pilot study. Dev Med Child Neurol 47: Nezu A, Kimura S, Uehara S, Kobayashi T, Tanaka M, Saito K. (1997) Magnetic stimulation of motor cortex in children: maturity of corticospinal pathway and problem of clinical application. Brain Dev 19: Child-friendly Constraint-induced Therapy Jeanne R Charles et al. 641

8 Steenbergen B, Van der Kamp J. (2004) Control of prehension in hemiparetic cerebral palsy: similarities and differences between the ipsi- and contra-lesional sides of the body. Dev Med Child Neurol 46: Taub E, Ramey SL, DeLuca S, Echols K. (2004) Efficacy of constraintinduced movement therapy for children with cerebral palsy with asymmetric motor impairment. Pediatrics 113: Taub E, Wolf SL. (1997) Constraint-induction techniques to facilitate upper extremity use in stroke patients. Top Stroke Rehab 3: Ueki Y, Oga T, Ikeda A, Hitomi T, Fukuyama H, Nagamine T, Shibasaki H. (2005) Dominance of ipsilateral corticospinal mirror movements. J Neurol Neurosurg Psychiatry 76: Willis JK, Morello A, Davie A, Rice JC, Bennett JT. (2002) Forced-use treatment of childhood hemiparesis. Pediatrics 110: Winstein CJ, Miller JP, Blanton S, Taub E, Uswatte G, Morris D, Nichols D, Wolf S. (2003) 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 17: Wolf SL, Lecraw DE, Barton LA, Jann BB. (1989) Forced-use of hemiplegic upper extremities to reverse the effect of learned nonuse among chronic stroke and head-injured patients. Exp Neurol 104: Wolf SL, Blanton S, Baer H, Breshears J, Butler AJ. (2002) Repetitive task practice: a critical review of constraint-induced movement therapy in stroke. Neurologist 8: Zancolli EA, Zancolli ER. (1981) Management of the hemiplegic spastic hand in cerebral palsy. Surg Clin North Am 61: Appendix I: Caregiver Functional Use Survey Bimanual tasks and scoring guidelines used with the caregiver survey for how frequently and how well children used the involved upper extremity in real-life situations. How frequently How well 1) Holds a book for reading using both hands 2) Uses both hands to towel-dry face or other body part 3) Carries an object in the affected hand while using the unaffected hand to perform a task such as opening the refrigerator 4) Uses both hands for dressing, e.g. holds shirt or trousers or pulls garments over head or hips using both hands 5) Carries an object in the unaffected hand while using the affected hand to perform a task such as opening the refrigerator 6) Uses both hands to carry a lunch tray 7) Opens a drawer with one hand and removes an object with the other 8) Uses both hands in food preparation, such as making a sandwich or stirring and stabilizing the bowl 9) Uses both hands to play video games that require two hands 10) Uses both hands to button a shirt 11) Uses both hands to zip a jacket 12) Uses both hands to put on and remove a backpack 13) Uses both hands in sports such as basketball, baseball, wiffle ball, volleyball 14) Uses both hands in picking up large objects such as boxes, balls, or laundry baskets How frequently scale Makes no attempt to use the affected arm in the activity Makes rare tries to use the affected arm in the activity Makes few tries to use the affected arm in the activity Makes frequent tries to use the affected arm in the activity Tries to use the affected arm almost every time the activity is performed 5 Uses the affected arm every time the activity is performed N/A Never performs the activity How well scale The affected arm was not used at all for that activity The affected arm was moved during the activity but was of very little use (very poor) The affected arm was of some use during the activity, but needed some help from the unaffected arm, moved very slowly or with difficulty (poor) The affected arm was used for the purpose indicated, but movements were slow or were made only with some effort (fair) The movements made by the affected arm were almost normal, but not quite as fast or accurate as normal 5 The ability to use the affected arm for that activity was equal to the ability to use the unaffected arm (normal) N/A Never performs the activity 642 Developmental Medicine & Child Neurology 2006, 48:

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