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Efficacy of Constraint-Induced Therapy on Functional Performance and Health-Related Quality of Life for Children With Cerebral Palsy: A Randomized Controlled Trial

Efficacy of Constraint-Induced Therapy on Functional Performance and Health-Related Quality of Life for Children With Cerebral Palsy: A Randomized Controlled Trial
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Transcript  Journal of Child Neurology online version of this article can be found at: DOI: 10.1177/0883073811431011 2012 27: 992 srcinally published online 12 January 2012 J Child Neurol  Yi-jung Hsin, Fei-Chuan Chen, Keh-chung Lin, Lin-ju Kang, Chia-ling Chen and Chung-yao Chen for Children With Cerebral Palsy : A Randomized Controlled TrialEfficacy of Constraint-Induced Therapy on Functional Performance and Health-Related Quality of Life  Published by:  can be found at: Journal of Child Neurology  Additional services and information for Email Alerts: Subscriptions: Reprints: Permissions: Citations:  What is This? - Jan 12, 2012OnlineFirst Version of Record - Jul 20, 2012Version of Record >> at NATIONAL TAIWAN UNIV LIB on July 20, 2012 jcn.sagepub.comDownloaded from   Original Article Efficacy of Constraint-InducedTherapy on Functional Performance andHealth-Related Quality of Life for ChildrenWith Cerebral Palsy: A RandomizedControlled Trial Yi-jung Hsin, MD 1 , Fei-Chuan Chen, MS, PT 2 ,Keh-chung Lin, ScD, OTR 3 , Lin-ju Kang, PhD, PT 4 ,Chia-ling Chen, MD, PhD 5,6 , and Chung-yao Chen, MD 7,8 Abstract To better generalize training effects to the context of daily living, home-based constraint-induced therapy has beenproposed. Therapeutic success of constraint-induced therapy is limited as to whether the improvements in functional per-formance can be transferred to quality of life. This randomized controlled trial aimed to investigate the efficacy of home-based constraint-induced therapy on functional performance and health-related quality of life. Twenty-two children withspastic unilateral cerebral palsy (6-8 years, 10 boys) were randomly assigned to receive constraint-induced therapy or tra-ditional rehabilitation. Home-based constraint-induced therapy had immediate and maintaining effects on motor efficacy andfunctional performance and induced greater gains in health-related quality of life in the long run than in the short term. Thehome-based constraint-induced therapy protocol (relatively moderate intensity and shortened constraint time), whichmight balance the effectiveness and compliance of participants and caregivers, may be an effective alternative to conven-tional constraint-induced therapy. Keywords cerebral palsy, home-based, constraint-induced therapy, upper extremity, quality of life Received August 30, 2011. Received revised October 30, 2011. Accepted for publication November 2, 2011. Cerebral palsy describes a group of movement and posturedisorders, causing activity limitation, that are attributed tononprogressive disturbances in a developing fetal or infant brain. 1 Based on a previous classification, spastic cerebral palsy is classified into diplegic, hemiplegic, quadriplegic, and monoplegic subtypes according to the topographic distribu-tion of affected areas of the body. The Surveillance of Cere- bral Palsy in Europe proposed a classification of unilateralmotor involvement of spastic cerebral palsy that differentiatesfrom bilateral motor involvement. 1 Children with unilateralmotor involvement or hemiparesis tend to neglect to use their more affected upper extremity; this is called developmentaldisregard. 2 Constraint-induced therapy is a method for treating develop-mental disregard by inducing extensive practice of the moreaffected upper limb in patients with unilateral motor involve-ment. Recent evidence suggests that constraint-induced ther-apy is one of the most effective techniques for improving useof the more affected upper extremity or reducing developmen-tal disregard in children with unilateral cerebral palsy. 3,4 The 1 Department of Physical Medicine and Rehabilitation, Kaohsiung Chang GungMemorial Hospital, Kaohsiung, Taiwan, ROC 2 Department of Physical Medicine and Rehabilitation, Buddhist Tzu ChiGeneral Hospital, Taipei Branch, Taipei, Taiwan, ROC 3 School of Occupational Therapy, College of Medicine, National TaiwanUniversity, Taipei, Taiwan, ROC 4 Department of Physical Therapy, Shu Zen College of Medicine andManagement, Kaohsiung, Taiwan, ROC 5 Department of Physical Medicine and Rehabilitation, Chang Gung MemorialHospital, Linkou, Taiwan, ROC 6 Graduate Institute of Early Intervention, Chang Gung University, Tao-Yuan,Taiwan, ROC 7 Department of Physical Medicine and Rehabilitation, Chang Gung MemorialHospital, Keelung, Taiwan, ROC 8 School of Medicine, Chang Gung University, Tao-Yuan, Taiwan, ROC Corresponding Author: Chia-ling Chen, MD, PhD, Department of Physical Medicine and Rehabilitation,Chang Gung Memorial Hospital, 5 Fu-Hsing st., Kwei-Shan, Tao-Yuan 333,Taiwan, ROCEmail:  Journal of Child Neurology27(8) 992-999 ª The Author(s) 2012Reprints and 10.1177/0883073811431011  at NATIONAL TAIWAN UNIV LIB on July 20, 2012 jcn.sagepub.comDownloaded from   use of constraint-induced therapy was first applied to the upper extremities of patients with stroke 5–7 and was then extended tothe upper extremities of young children with cerebral palsy. 4,8 Several systematic reviews 3,8,9 and randomized controlled trials 2,4,10–15 have supported the use of constraint-induced ther-apy for children with cerebral palsy.Therapeutic success of constraint-induced therapy is limited as to whether the improvements in functional performance can be transferred to quality of life. Quality of life is defined as anoverall assessment of well-being in multiple life domains and health-related quality of life is one of the domains directlyrelated to an individual’s health. 16 Health-related quality of lifein children with functional limitations has been increasinglyrecognized as an important outcome of intervention. Researchhas demonstrated that constraint-induced therapy promoted hand function at the activity level 2,4,10–15 and participationlevel. 17,18 In children with cerebral palsy, hand function playsan important role in determining their participation in dailyactivities, 19 which may further affect their quality of life. How-ever, no studies have investigated the effects of home-based constraint-induced therapy on health-related quality of life inchildren with cerebral palsy.To better generalize training effects to the context of daily living, home-based constraint-induced therapy has been proposed. 11,14,20 High intensity and prolonged con-straint time in conventional constraint-induced therapy mayreduce the compliance of children and their caregivers and,thus, may not be feasible in clinical practice. Home-based  programs that integrate therapeutic programs into a child’sdaily activities may enhance family and child participationin the therapeutic activities in a child’s natural environment.A previous study suggested that home-based constraint-induced therapy is a feasible and effective alternative toconventional therapy administered at clinics. 11 Although theimportance of home-based therapy has been emphasized,most of the randomized controlled trials 10,12,13,15 delivered constraint-induced therapy in a laboratory or clinical setting.Research involving home-based constraint-induced therapyin children with cerebral palsy is limited and in need of fur-ther investigation. 11,14 We aimed to conduct a well-designed randomized con-trolled trial to investigate the efficacy of home-based constraint-induced therapy in children with cerebral palsy,using the traditional rehabilitation group as control. Out-come measures were upper limb skill, functional perfor-mance, and health-related quality of life perspectives. Wehypothesized that children with cerebral palsy receivinghome-based constraint-induced therapy would have better outcomes in upper limb skills, functional performance, and health-related quality of life than those receiving traditionalrehabilitation, and the beneficial effects would be retained at 3 months (follow-up). Knowledge of this study will broaden clinicians’ understanding of the overall health sta-tus of children with cerebral palsy after constraint-induced therapy. Methods Participants The study recruited 23 children with cerebral palsy aged 6 to 8 yearsfrom the Rehabilitation Department of Chang Gung Memorial Hospi-tal, a tertiary medical center. Inclusion criteria were as follows: (1)diagnosed with congenital unilateral spastic cerebral palsy; (2) consid-erable nonuse of the more affected upper limb (amount-of-use scoreon the Pediatric Motor Activity Log <2.5); (3) active extension move-ment of the wrist and metaphalangeal joint   10 degrees; and (4) noexcessive muscle tone (Modified Ashworth Scale   2 for any jointon the upper limb) before starting treatment. Exclusion criteria wereas follows: a severe cognitive, visual, or auditory disorder; a severeconcurrent illness or disease not typically associated with cerebral palsy; active medical conditions such as pneumonia; any major sur-gery or nerve blockage (such as botulinum toxin or phenol injection)within 6 months before interventions; and poor cooperation duringassessments. The Institutional Review Board for Human Studies atChang Gung Memorial Hospital approved the study protocol, and caregivers of all participants gave written informed consent.Figure 1 shows the flow diagram of the randomization procedure.Among the 75 children who underwent eligibility assessment, 23 wereeligible for subsequent randomization procedure. One child inthe con-trol group dropped out during follow-up because of lack of transpor-tation. Finally, a total of 22 children with spastic unilateral cerebral palsy, aged 6 to 8 years (10 boys and 12 girls) were included in thedata analysis. Severity of fine motor limitation was classified usinga grading system of Bimanual Fine Motor Function. 21 The BimanualFine Motor Function system is a 5-level ordinal qualifier that gradesthe extent and magnitude of a problem in participation. Extent and  Assessed for eligibility (n=75) Excluded (n=52)   Not meeting inclusion criteria (n=42)  Refusal (n=10) Randomized (n=23)hCIT (n=11)TR (n=12) Withdrew (n=1)due to lack of transportation Analyzed (n=11)Analyzed (n=11) Figure 1.  Flow diagram of the randomization procedure in this study.Abbreviations: hCIT, home-based constraint-induced therapy; TR,traditional rehabilitation. Hsin et al   993  at NATIONAL TAIWAN UNIV LIB on July 20, 2012 jcn.sagepub.comDownloaded from   magnitude are graded as no problem, mild problem, moderate prob-lem, severe problem, or complete problem. 21 Design and Procedures All participants underwent a series of examinations to assess primary and secondary outcomes. Participants were randomlyassigned to the home-based constraint-induced therapy (n  ¼ 11) or traditional rehabilitation group (n ¼ 12). The randomiza-tion is generated from a table of random numbers by a statisti-cian outside the research department. Tests were administered  before, immediately after, and at 3 months after the 4-week intervention by a trained rater blinded to group assignment.A certified occupational therapist, blinded to the group alloca-tion, was trained by the coordination center, as a preconditionfor study participation. Participant characteristics, includingage, gender, more affected limb, and constraint time in theconstraint-induced therapy group were also recorded. Intervention Both groups received individualized home-based interventionsof 3.5 to 4 h/d, twice per week for 4 weeks, from a certified  physical therapist. The constraint-induced therapy focused onfunctional training of the more affected arm, with the principlesof shaping and repetitive task practice applied during training.In addition, participants in the constraint-induced therapygroup were required to wear an elastic bandage and restraintglove that limited their wrist and individual finger movement.Traditional rehabilitation (control) group children wereengaged in functional unilateral or bilateral arm training based on function-oriented activities, neurodevelopment treatmenttechniques, and motor learning and control principles.Outside the therapy sessions, participants in both groupswere encouraged to exercise or perform daily activities (eg,reaching, grasping, manipulating, and self-care activities) athome under parental supervision. Participants in theconstraint-induced therapy group were also encouraged to wear the elastic bandage and restraint glove for 3.5 to 4 h/d whiledoing exercise or daily activities. Parents were asked to docu-ment the number of restraint hours outside therapy in dailylogs. Differences between groups were constraint usage and treatment applied during therapy sessions. There were noadverse physical effects or harmful events related to interven-tion that occurred during the study period, except that somechildren experienced frustration in the early stages of constraint-induced therapy. Outcome Measures Primary outcome was measured by the Bruininks-OseretskyTest of Motor Proficiency, 22 an upper-extremity efficiencyassessment. Secondary outcome measures were the PediatricMotor Activity Log 23 and Cerebral Palsy–specific Quality of Life instrument. 24 Primary Outcomes Subtest 8 of the Bruininks-Oseretsky Test of Motor Proficiencywas used to evaluate arm movement speed and dexterity.Unimanual tasks were performed by the more affected arm.The Bruininks-Oseretsky Test of Motor Proficiency, with ahigher raw score indicating better performance, has well-established psychometric properties for the total scale as wellas for each subscale for children with motor disabilities. 22 Secondary Outcomes Parents completed the Pediatric Motor Activity Log 23  —ahigher score indicates better performance—to rate their percep-tions of how much and how well their child used the moreaffected upper extremity. Two subscales documenting Amountof Hand Use and Quality of Hand Use were included.The Cerebral Palsy–specific Quality of Life is a measure of health-related quality of life specific to children with cerebral palsy. 24 Internal consistency has been reported in the rangeof 0.74 to 0.92 for primary caregivers, and 0.80 to 0.90 for child self-report. For primary caregivers, 2-week test–retest reliabil-ity was 0.76 to 0.89. In this study, the parent-proxy version wasused. The health-related quality of life contains 7 domains:social well-being and acceptance, participation and physicalhealth, functioning, emotional well-being and self-esteem, painand impact of disability, access to services, and family health.The algebraic mean of item values can be computed for eachdomain; a higher mean value indicates a higher quality of life,except for the domain of pain and impact of disability. Statistical Analysis Descriptive and univariate analyses were conducted using Sta-tistical Package for Social Science (SPSS) 12.0 software (SPSSInc., Chicago, Illinois). To determine comparability at baselineof demographic and clinical characteristics, the independent 2-sample  t   test was used for continuous variables and the chi-square test was used for categorical variables. To investigate Table 1.  Demographic and Baseline Characteristics of Both GroupsVariables hCIT (n ¼ 11) TR (n ¼ 11)  P  Age (y) 6.9  +  0.6 6.9  +  0.6 .870 a SexBoys 5 (46) 5 (46) 1.000 b Girls 6 (54) 6 (54)More affected armRight 6 (55) 6 (55) 1.000 b Left 5 (45) 5 (45)BFMFLevel I 2 (18) 1 (9) 1.000 b Level II 9 (82) 10 (91) Abbreviations: hCIT, home-based constraint-induced therapy; TR, traditionalrehabilitation; BFMF, bimanual fine motor function.Note: Values are expressed as mean  +  standard deviation or number (%). a t  tests. b Chi-square tests. 994  Journal of Child Neurology 27(8)  at NATIONAL TAIWAN UNIV LIB on July 20, 2012 jcn.sagepub.comDownloaded from   whether the constraint-induced therapy group improved morethan the control group at posttest and at 3-month follow-up,analysis of covariance (ANCOVA) was applied to each out-come variable. Pretest performance was the covariate, groupwas the independent variable, and posttest and follow-up per-formance were separate dependent variables. Significancelevel was set at .05. Effect size Z 2 was calculated for each out-come variable to index the magnitude of group differences. Alarge effect is represented by an Z 2 of at least .138, a moderateeffect by an  Z 2 of .059, and a small effect by an  Z 2 of .01. 25 Results Demographic and Baseline Characteristics Twenty-two participants, 11 in the constraint-induced therapygroup and 11 in the control group, completed this study. Tables1 and 2 summarize demographic and baseline clinical charac-teristics of the participants in both groups. Characteristics werecomparable between these 2 groups; no differences existed for all outcome measures between the 2 groups. The average con-straint time in constraint-induced therapy group is 3.5 (SD  ¼ 0.1) hours, ranging from 3.3 to 3.8 h/d. Primary Outcomes For upper limb skill, both groups demonstrated improvementsin the Bruininks-Oseretsky Test of Motor Proficiency scores at posttreatment and at the 3-month follow-up. The ANCOVAanalyses showed that the constraint-induced therapy groupimproved more on the Bruininks-Oseretsky Test of Motor Pro-ficiency than the traditional rehabilitation group with a largeeffect at posttreatment (  F  1, 19  ¼  16.873,  P  ¼  .001,  Z 2 ¼ 0.470; Table 2) and at 3-month follow-up (  F  1, 19  ¼  16.311,  P ¼ .001,  Z 2 ¼ 0.462). Secondary Outcomes For functional performance, both groups had improved Pediatric Motor Activity Log scores at posttreatment and 3-month follow-up. The ANCOVA analyses showed that theconstraint-induced therapy group improved more on theAmount of Hand Use subscale (  F  1, 19  ¼  14.806,  P  ¼  .001, Z 2 ¼ 0.438;  F  1, 19 ¼ 5.774,  P ¼ .027, Z 2 ¼ 0.233; Table 2) and Quality of Hand Use subscale (  F  1, 19 ¼ 13.456,  P ¼ .002, Z 2 ¼ 0.415;  F  1, 19  ¼  5.899,  P  ¼  .025,  Z 2 ¼  0.237) than the tradi-tional rehabilitation group, with a large effect at posttreatmentand 3-month follow-up, respectively.The Cerebral Palsy–specific Quality of Life scores for bothgroups improved at posttreatment and at 3-month follow-up.The ANCOVA analyses showed that the constraint-induced therapy group improved more on the domains of socialwell-being and acceptance (  F  1, 19  ¼  10.979,  P  ¼  .004,  Z 2 ¼ 0.366; Table 2), functioning (  F  1, 19  ¼  5.861,  P  ¼  .026,  Z 2 ¼  0.236), participation and physical health (  F  1, 19  ¼  4.161,  P  ¼  .056,  Z 2 ¼  0.180), emotional well-being and self-esteem (  F  1, 19  ¼  9.202,  P  ¼  .007,  Z 2 ¼  0.326), pain and impact of disability (  F  1, 19  ¼  9.054,  P  ¼  .007,  Z 2 ¼  0.323),and access to services (  F  1, 19  ¼  7.729,  P  ¼  .012,  Z 2 ¼ 0.289) than the traditional rehabilitation group with a largeeffect at 3-month follow-up, but not for family health. How-ever, no significant differences were found betweenconstraint-induced therapy and traditional rehabilitationgroups for all Cerebral Palsy–specific Quality of Lifedomains at posttreatment. Discussion This is the first study, to our knowledge, to investigatehealth-related quality of life quantitatively for children withcerebral palsy receiving home-based constraint-induced ther-apy using a randomized controlled trial design. The home- based constraint-inducedtherapytreatmentprotocolinthisstudyis an effective alternative to conventional constraint-induced therapy. This study showed that the home-based constraint-induced therapy program improved motor efficacy to a greater extent and induced greater gains in functional performance thantraditional rehabilitation at posttreatment and the 3-monthfollow-up. Furthermore, the home-based constraint-induced therapyprogramgeneratedgreatergainsinhealth-relatedqualityof life in the long run than in the short term.The home-based constraint-induced therapy protocol, withrelatively moderate intensity and shortened constraint time, isan effective strategy because this protocol helps to balance theeffectiveness and compliance of participants and their care-givers. All participants in this study complete the home- based therapy. This home-based constraint-induced therapy protocol is similar to the protocol designed by Lin et al. 11 Huang et al 8 indicated that the duration and frequency of constraint-induced therapy and constraint time for childrenwith cerebral palsy vary widely. The total amount of constraint-induced therapy intervention ranged from 3 to 126hours with constraint time from 2 to 24 hours daily. 8 Theconstraint-induced therapy intervention duration ranged from1 hour per week to 7 hours per day for 10 days to 8 weeks. 8 High intensity and long constraint time with conventionalconstraint-induced therapy are not feasible in clinical careenvironments. Additionally, such protocols may reduce com- pliance and participation of children and their caregivers. Toenhance child compliance, this study used a moderate intensity(ie, a total of 28-32hours in this study) and shortened constrainttime. Although this regimen produced positive effects, further evaluation is needed to determine optimal dosage of interven-tion and constraint duration.The significant differences in health-related quality of life between the constraint-induced therapy and control groupswere found at 3-month follow-up but not at posttreatment, indi-cating that the home-based constraint-induced therapy programgenerated greater gains in most health-related quality of lifedomains in the long run, but not in the short term, than tradi-tional rehabilitation. The reason may be that children were fru-strated in the early stages of constraint-induced therapy by their inability to perform activities with their less affected arm. 11 Hsin et al   995  at NATIONAL TAIWAN UNIV LIB on July 20, 2012 jcn.sagepub.comDownloaded from 
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