A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation
Conditions: Cerebral Palsy
Sponsor: International Clinic of Rehabilitation, Ukraine

1 
Hand function in children with cerebral palsy undergoing Intensive 
neurophysiological rehabilitation.  
Study protocol 
May 15, 2017 
Translated into English from Ukrainian to English by principal investigator Oleh Kachmar 
 
International Clinic of Rehabilitation, Ukraine  
Principal Investigator: Oleh Kachmar, Head of Innovative Technologies Department 
Affiliation: International Clinic of Rehabilitation, Ukraine 
Tel: +380673537927, Email: okachmar@ic.reha.lviv.ua   
Contact Backup: Anna Kushnir, MD, Tel +380635922667,  Email: anna@ic.reha.lviv.ua 
Introduction 
Cerebral palsy (CP) is the most common cause of childhood physical disability with an 
estimated prevalence of 2.11 per 1000 live births.1 Limited hand function is a common disabling 
impairment in children with CP and a strong predictor of a child’s restricted ability to participate in 
daily activities.2 Upper limb disorders in CP include weakness, sensory impairment, spasticity, and 
dystonia.3 Children with CP experience difficulties with grasping and releasing objects due to an 
imbalance between wrist flexors and extensors.4 Everyday activities, self-care, and domestic tasks 
are often hard for them to accomplish.  
Growing evidence suggests that high-intensity therapies for upper limb dysfunction in 
children with CP are more effective compared to usual, less intensive care, suggesting that the 
dosage, i.e., treatment amount and frequency, is as important as the treatment itself.5,6,7,8 The 
most promising options are constraint-induced movement therapy (CIMT)—a unimanual 
training—and hand-arm bimanual intensive therapy (HABIT)—a bimanual training.9,10 Both 
therapies improve unimanual movements, bimanual capacity, and movement efficiency in children 
with CP.11,12 Several studies suggested that structured bimanual training might drive 
neuroplasticity by increasing the size of the motor map of the affected hand and improving action 
planning of the upper limb movements.13,14  

2 
Setting rehabilitation goals that are realistic and relevant to the daily life is also essential.15 
Intensive, activity-based, goal-directed functional interventions were more effective than standard 
care in improving hand function, self-care, and individualized outcomes.11,16 An intensive program 
combining group and individual sessions resulted in a high rate of goal attainment, even though 
the participants were of different age and functional levels and had different goals.17 Studies also 
showed that a short high-intensity course combining interventions for upper and lower extremity 
improved function of both upper and lower extremity in children with unilateral and bilateral 
spastic CP more effectively than conventional treatment (delivered over a longer period).18,19 
The interventions that proved to be effective share similar features—they are high-dose, 
repetitive, incrementally challenging, goal-oriented, and functional. So, the attention of 
researchers and clinicians is currently focused on the exploration of intensive, goal- and function-
oriented approaches addressing multiple limitations.  
One of such approaches is Intensive Neurophysiological Rehabilitation System (INRS)—a 
two-week multicomponent course that combines several interventions for both upper and lower 
limbs and addresses different functional goals.20 The interventions include age-appropriate 
unimanual and bimanual fine and gross motor activities, the difficulty of which gradually increases. 
INRS components are as follows: physical therapy, occupational therapy, spinal manipulative 
therapy, gait training, joint mobilization, strength training, full body massage, computer game 
therapy, suit therapy, and group sessions of rhythmic gymnastics. The course is flexible in that 
regard that the dose of each component and the components themselves are modified to suit a 
patient’s condition and goals. It is intensive but child-friendly at the same time, because the 
activities involve elements of play. Several studies reported positive effects of INRS on children 
with CP, including improvement of gross motor functions, reduction of spasticity, increase in 
passive range of motions, and development of fine motor skills.21,22 
This study was prompted by promising results from studies on different types of intensive 
goal-oriented training for upper limb dysfunction and positive effects of intensive INRS use in 
patients with CP. The aim of present study was to assess changes in hand function in children with 
bilateral spastic forms of cerebral palsy after the two-week treatment with INRS. 
Materials and methods 
A prospective case series study design would be used. Conducting the study and inclusion 
of children with disabilities will be approved by the local Ethical Commission. Participants and their 
legal representatives will receive comprehensive information about the intervention and study 

3 
design. Written informed consent would be obtained from legal representatives. Verbal assent will 
be given by participants, when appropriate, based on age and cognitive skills.  
Participants 
Patients of the tertiary care facility will be assessed for eligibility. Inclusion criteria were 
spastic forms of CP, bilateral impairment, age 6 to 15 years, Manual Ability Classification System 
(MACS) level I-III. Exclusion criteria are moderate to severe cognitive deficit, uncooperative 
behavior, severe contractures of upper extremity joints, previous hand surgery, and epilepsy with 
frequent seizures. After applying the exclusion criteria, 32 patients (mean age 10.2 years; 17 
males) were selected for the study. The dominant hand was established based on parental report 
and medical history. 
Intervention 
All participants will undergo a two-week Intensive Neurophysiological Rehabilitation 
System (INRS) course in the tertiary care facility. INRS is a novel intensive approach that combines 
several multi-faceted rehabilitative components to improve functioning and quality of life of 
children with CP.20 INRS involves active and passive treatment components that complement and 
reinforce each other. Active components are aimed at acquisition of new skills and abilities while 
passive components prepare physiological background for skills development. 
INRS program course is tailored individually based on age, motor abilities, and functional 
goals within International Classification of Functioning, Disability and Health (ICF) domains. The 
program course includes repeated procedures in which the difficulty of required movements is 
gradually increased. Repetitive tasks with gradually increasing complexity and motivation 
reportedly thought to stimulate plastic changes in the brain.24 The components are developed to 
be child-friendly and take into account the motivational aspect of rehabilitation. They focus on the 
functional performance of daily life activities along with improvement of the postural control and 
locomotion. 
The course involves 11 days of treatment (6 days during the first week, and 5—during the 
second), 4 to 5 hours daily and up to 55 hours in total. Treatment is provided by a multidisciplinary 
team of experienced medical doctors, physical therapists, and nurses. The quality of every 
component delivery is controlled by the supervisor. No adverse events were reported during the 
intervention.  

4 
Outcome Measures 
The same evaluators will assess each child two times: before and after the two-week 
course of INRS. The evaluators would not be involved in treatment.  
Primary outcome measure 
The Jebsen-Taylor hand function test (JTHFT) assesses performance of seven manual tasks 
mimicking common activities of daily living.25 The JTHFT reflects changes in the category Dexterity 
of the Body Functions and Body Structures domain of the ICF, and the subcategory Carrying, 
moving or manipulating objects of the Activity domain of the ICF.26 Although the JTHFT was 
primarily designed for adult patients, it was also proved a reliable and responsive tool for tracking 
short-term changes in children with CP.27,28  
The test consists of seven subtests: writing a simple sentence, card turning, picking up 
small common objects, spooning five kidney beans into a bowl, stacking four checkers, moving 
large light objects, and moving large weighted objects. The writing task was excluded because 
some children were too young.27 The supposedly weaker hand, usually the more affected, non-
dominant hand was evaluated first.  
JTHFT measures the time it takes the child to complete the standardized functional tasks 
with each hand and better performance. Maximum two minutes are allowed for a subtest. The 
total score for a hand is a sum of all subtest times for that hand. A lower score indicates better 
performance.  
Secondary outcome measures 
ABILHAND-Kids questionnaire is a measure of manual ability for children with upper limb 
impairments.29 Manual ability refers to the Activity domain of the ICF. A parent or a caregiver is 
asked to assess how difficult it is for a child to accomplish a set of 21 selected activities of daily 
living on a three-level scale (impossible, difficult, easy). When giving the assessment, the 
responder should focus on the result of the activity and not on the method used to accomplish it 
(e.g. it is not important if the child uses one or both hands).  
The items of the questionnaire are presented randomly to avoid systematic effect. The 
questionnaire was designed using the Rasch measurement model that allows converting raw 
scores into linear units on a unidimensional scale. We used the Ukrainian version of ABILHAND-
Kids that had been adapted and validated for the Ukrainian population.30  

5 
Manual dexterity was evaluated with Box and Blocks test (BBT), a valid and reliable 
measure for different categories of patients with neurological impairments 28,31. For children with 
cerebral palsy, the test was proved to be sensitive in short-term interventions 28. BBT covers 
Dexterity category of the Body Functions and Body Structures domain of the ICF. The child has one 
minute to carry as many blocks from one compartment of the box to another as possible 31. The 
scores of BBT are the number of blocks, carried over by each hand.  
Grip strength was measured with a Jamar hand dynamometer (Performance Health, USA). 
This device has good test-retest and interrater reliability according to a systematic review for 
upper extremity strength measurement in children with CP 32. Hand-grip dynamometry 
encompasses the Muscle strength functions category of the Body Functions and Body Structures 
domain of ICF. Three measurements of maximum voluntary contractions were taken for each 
hand, and the best result was recorded. 
 
 

6 
Statistical Analysis Plan 
IBM SPSS v23 software will be used to perform statistical analysis. Normality will be 
assessed using the Kolmogorov-Smirnov test.  
For normally distributed variables descriptive statistics includes means with standard 
deviation (SD) values. Baseline and post-intervention results will be compared using the Paired 
Sample two-tailed T-Test with 95% confidence interval. In calculations, statistical significance level 
(α) was taken as 5% and values with p<0.05 expressed statistical significance.  
In case of non-normal distribution, nonparametric statistics would be used. Medians with 
interquartile range will be used for descriptive statistics, Wilcoxon signed-rank test would be used to 
compare baseline and post-intervention data 
 
 

7 
Informed Consent Form 
 
Informed consent for parents  
of children participating in the study 
 
We ask for your participation in the research project “Hand function in children with 
cerebral palsy undergoing Intensive neurophysiological rehabilitation.”which aims to assess the 
effect of Intensive Neurophysiological Rehabilitation system on arm function in patients with 
cerebral palsy. 
Our previous studies describe an increase in arm strength and dexterity in a group of 
children with cerebral palsy after a course of Intensive Neurophysiological Rehabilitation. But 
other important components of hand function (such as hand involvement in a child's daily 
activities) were not evaluated in this study. 
Procedure 
Participating children will be additionally assessed two times: before and after the two-
week treatment course in the International Clinic of Rehabilitation. The evaluators would not be 
involved in treatment.  
The evaluation will consist of four components: 
 
The Jebsen-Taylor test is a tool for assessing a child's performance of a list of tasks that are 
often used in everyday life. 
 
Abilhand-Kids questionnaire is a tool for assessing the child's ability to perform daily 
activities that require the participation of the upper extremities. 
 
Test "Box and Blocks" - assessment of dexterity. 
 
Dynamometry - assessment of hand strength using a Jamar wrist dynamometer. 
No component of the examination causes pain or other discomfort to the patient. 
Participation in the study is completely voluntary, there is no risk of participation in the 
study. Participants or their representatives have the right to withdraw at any time without 
explanation. 
The research team guarantees each patient’s confidentiality and guarantees that the 
research’s results will not be used for other purposes than those detailed in the project. 

8 
Personal data will not be collected, stored or distributed. All personal information will be 
anonymous and encrypted. In any case, neither the name nor other personal data will be disclosed 
in research articles or at the request of third parties. 
Certificate of consent 
I have been informed, in a comprehensive way, about these and other aspects of my 
possible participation in the project (through the information sheet) and I have had the 
opportunity to ask questions and to resolve any doubt that I might have. I have decided to 
participate in the project knowing that this decision does not affect the care and treatment that I 
am receiving in the Clinic, and I am also aware that I can withdraw from the study at any time. 
Also, my son/daughter/dependent has been informed and has understood the procedures 
of the study. All his/her questions and doubts have been answered and he/she has voluntarily 
consented to participate in the project. 
I have been informed that my personal data will be properly stored and processed. 
I freely and voluntarily agree that my son/daughter/dependent participates in the project. 
And that is why I explicitly authorize this consent form. 
 
Name of the participant: 
____________________________________________ 
Name of parent or legal guardian:  ____________________________________________ 
Parent or legal guardian’s signature: ____________________________________________ 
 
Date: “____” _________ 20      
 
Statement of the contact person: I have explained the nature and purpose of this research, 
as well as the possible risks to participants. I have answered the questions made by the 
interviewee. I will provide the parents or guardians with a copy of the informed consent. 
 
Contact person name and signature ___________________________________