Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Phase: NA
Conditions: Cerebral Palsy Spastic Hemiplegic
Sponsor: Samsung Medical Center

CLINICAL TRIAL PROTOCOL 
 
 
 
 
Therapeutic Effects of Constraint-Induced Movement 
Therapy on Young Children With Cerebral Palsy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT no.: NCT03858335 
Protocol ID: 2015-06-100-008 
Date of the document: September 29, 2019 

Background 
Cerebral palsy (CP) occurs when the immature brain develops non-progressive lesions due 
to multiple causative factors, resulting in impaired motor and postural function.1 Unilateral 
CP, which accounts for nearly 30% of all cases,2 is characterized by sensory and motor 
impairment on the unilateral side. Children with unilateral CP tend to only use the non-paretic 
side after discovering that it is more effective and efficient in performing tasks, even though 
impairment of the paretic hand is mild, which does not prevent them from performing daily 
tasks.3 This so-called “developmental disregard”4 can be reduced by constraint-induced 
movement therapy (CIMT). CIMT is a therapy that forces the use of the paretic upper limb 
by restraining the non-paretic limb. To demonstrate the effect of CIMT on developmental 
disregard, evaluating the amount of paretic arm use in real-life situation is important. For this 
reason, Pediatric Motor Activity Log (PMAL),5 a questionnaire-based test that assesses the 
real-world use of the paretic upper limb, has been frequently used in CIMT studies.5-7 
However, PMAL is a parental-rating scale; thus, it may not be completely objective. In 
addition, several standardized assessments that evaluate the motor function of upper 
extremities are available, but those tools only focus on measuring a child’s capacity to use the 
paretic upper extremity. Actual use of the paretic upper limb in the real world differs from its 
motor capacity.8 
Accelerometer is an objective instrument used to assess physical activity in structured and 
unstructured settings in the general pediatric population.9 This tool has become the preferred 
method for objectively examining real-world physical activity owing to its affordability and 
portability. Recent study has suggested that ActiGraph accelerometer is a valid and reliable 
tool for children with CP10 including toddlers.11 Coker-Bolt et al. applied accelerometers to 
determine the effects of CIMT on paretic arm use in real-life situations, but 7/12 participants 
showed no increase in the amount of paretic arm use after CIMT.12 A plausible explanation 

for this unexpected result was the age of participants (mean: 4.9 years). An animal study 
confirmed that early CIMT during the corticospinal tract (CST) refinement period is effective 
for motor performance, and no longer effective once the CST refinement period has passed.13 
Considering that the myelination of the CST is complete by 3 years of age in humans,14 
application of CIMT in infants and toddlers is expected to yield different results. 
 
Study Objective 
The main purpose of this study is to determine whether modified CIMT (mCIMT) with 
continuous restraint is feasible for infants and toddlers with unilateral CP and is effective in 
enhancing the amount of paretic arm use in the real world. The study is based on the 
hypothesis that mCIMT would be feasible and facilitate better use of the paretic hand in the 
real world.  
 
Methods 
Participants 
Informed consent forms were obtained from the children’s parents or legal guardians 
before enrollment. From November 2015 to October 2018, we prospectively enrolled 
consecutive children with unilateral CP who were admitted to a territory hospital in Seoul, 
Republic of Korea. The inclusion criteria were (1) age 7 to 36 months and (2) diagnosed with 
unilateral CP due to central nervous system lesions. The exclusion criteria were (1) severe 
cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, 
grasping), (2) untreated seizures, (3) visual or auditory problems interfering with treatment, 
and (4) prior history of musculoskeletal disorders. We asked parents to report if their child 
presented any adverse events such as sleep disorder or skin rashes. This study excluded 

participants whose potential risks exceeded the efficacy, and those with absence rates >20% 
(>3/15 sessions). 
 
Study design 
Thirty-two potential participants received a face-to-face screening assessment. A sample of 
32 eligible participants were randomized into the mCIMT or control group by permuted 
block randomization with block length 4 (N=16 per group). The evaluations were performed 
on two occasions: at baseline and immediately after the intervention. Only children in the 
control group who participated in the accelerometer study (N=4) underwent an additional 
evaluation to determine whether changes in the values of accelerometers were due to mCIMT 
or whether they changed as they grew older. The measures were conducted by occupational 
and physical therapists with more than 10 years of experience who were blinded to the 
intervention. 
 
Modified constraint-induced movement therapy (mCIMT) 
Each child in the mCIMT group wore an individually tailored plastic forearm resting splint 
that is detachable on his or her non-paretic side for 3 weeks. The therapist removed the splint 
for 15 minutes before each mCIMT session to allow for active range of motion of the non-
paretic upper limb and to assess non-paretic hand function by the grasping domains of 
PDMS-2. The participants could take off the splints during washes and while in sleep. In 
addition, parents were asked to take off the splints and report if adverse events such as 
increase of stress/crying, sleep disorders, or skin rashes occurred. A standardized pediatric 
CIMT protocol, which is a technique to shape motor behavior with repetitive and 
concentrated training of the paretic upper limb according to Taub’s and Deluca’s protocol,15,16 
was applied by an occupational therapist. The 15 treatment sessions occurred over a 3-week 

period (excluding weekends) in the mCIMT group, for 2 hours each (30-hour dosage in total). 
The control group received no mCIMT protocol except for children who wore 
accelerometers; they received mCIMT protocol post-test. All subjects who participated in this 
study retained the occupational or physical therapy they received. 
 
Statistical analyses plan 
Baseline characteristics between the mCIMT and control groups will be compared using 
independent t-test, chi-square test, and Fisher’s exact test. Differences between groups in 
standardized assessments at post-treatment will be compared with analysis of covariance 
using pre-treatment measures as covariates to determine the effect of mCIMT treatment. In 
addition, pre- and post-treatment outcomes of standard assessments will be compared using 
paired t-test in each group, and Wilcoxon signed-rank test was performed to compare pre- 
and post-treatment accelerometer outcomes (VMA, %MVPA, UR) of the eight children. 
Effect sizes will be expressed as partial eta-squared, which was calculated and reported as 
recommended by Cohen.17 The ranges for effect sizes are small (.01 <ηp2 <.06), moderate 
(.06 <ηp2 <.14), and large (ηp2 >.14). Data analyses will be conducted using IBM SPSS 
Statistics for Windows, version 21.0 (IBM Corp., Armonk, NY). 
 
 
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