Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Marmara University

 
1 
 
 
 
 
 
 
Development of Simulated Hippotherapy System and Investigation of the 
Effectiveness in Children with Cerebral Palsy 
 
 
 
 
 
 
 
Study Protocol with Statistical Analysis Plan (SAP) and Informed Consent Form 
(ICF) 
 
 
 
 
 
 
 
February 28, 2019 
 
 

 
2 
 
 
 
 
 
Development of Simulated Hippotherapy System and Investigation of the 
Effectiveness in Children with Cerebral Palsy 
 
 
 
 
Study Protocol  
(Pages 2 – 6) 
 
 
 
 
 
 
 
 
 
 
 
 
February 28, 2019 
 

 
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Study Protocol  
Study titled “Development of Simulated Hippotherapy System and Investigation of the 
Effectiveness in Children with Cerebral Palsy”was approved by Marmara University Faculty 
of Medicine Clinical Researches Ethics Committee meeting on 07.04.2017 with approval 
number: 09.2017.297 (Annex-1). 
The legal representatives of the children who participated in the study were informed 
about the aim, duration and the programs to be applied throughout the study. Volunteer 
Information Form has been signed and approved in accordance with the standards deemed 
appropriate by the Clinical Researches Ethics Committee of Marmara University Faculty of 
Medicine (This form can be seen on Informed Consent Form (ICF) section). The study was 
conducted in accordance with the Declaration of Helsinki. 
 
Hypothesis of the Study 
H0: Addition of the exercises performed with Simulated Hypotherapy device to the 
neurodevelopmental (NDT) based rehabilitation program in children with cerebral palsy does 
not contribute positively in improving the efficiency of lower extremity functions, body 
control and spasticity. 
H1: Addition of the exercises performed with Simulated Hypotherapy device to the 
neurodevelopmental (NDT) based rehabilitation program in children with cerebral palsy 
contributes positively to improve the efficiency of lower extremity functions, body control 
and spasticity. 
 
Randomization of the Study Groups 
Children with Cerebral Palsy who applied to the Bulgurlu Unimpeded Life Center for 
rehabilitation were invited to participate in the study. Children who volunteered to participate 
and whom met the criteria for participation were randomized with simple random sampling 
method and divided into two groups. Individual Neurodevelopmental (NDT) based 
rehabilitation programs were applied to the participants in Group I for 8 weeks. After 8 weeks 
of only Neurodevelopmental therapy (NDT) based rehabilitation, Simulated Hypotherapy 
system was added to the rehabilitation program, and the name of the was changed into Group 
II (the study group). 

 
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Inclusion Criteria 
•    Having a diagnosis of Spastic Cerebral Palsy, 
• 
Children aged between 5 - 18 years, 
• 
GMFCS level is I, II or III, 
• 
Independent seating 
• 
Walking at least 10 meters independently,  
• 
Can understand simple verbal instructions, 
• 
Those with a spasticity level less than 2 according to MAS, 
• 
Having bilateral hip abduction enough to sit on the hippotherapy device, 
• 
Voluntary acceptance to participate in the study 
 
Exclusion Criteria 
• 
Having hip dislocation, 
• 
Severe contracture or deformity, 
• 
Scoliosis (above 20 degrees), 
• 
Acute uncontrolled acute seizures, 
• 
Epilepsy, 
• 
Visual and auditory problems, 
• 
Injection of botulinum toxin in the last 6 months, 
• 
History of surgical operation such as muscle relaxation, tendon extension and 
selective dorsal rhizotomy in the last 6 months. 
 
Applied Evaluations 
Evaluations are applied three times: before treatment, in week 8 (end of NDT) and in 
week 16 (end of simulated hippotherapy training). All evaluation data are noted to 
‘Participants Tracking Form’ (Annex-2).  Primary outcome measures and applied evaluations 
are shown in Table 1.  
Table 1. Primary outcome measures and applied evaluations 
Primary Outcome Measures 
Applied Evaluations 
Functional Level 
Gross Motor Functional Classification 
System (GMFCS) 

 
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Spasticity 
Modified Ashworth Scale (MAS) 
Range of Motion (ROM) 
Goniometer 
Gross Motor Function 
Gross Motor Function Measure - 88 
Trunk Movements 
Trunk Impairment Scale (TIS) 
Functional Independence 
The Functional Independence Measure for 
Children (WeeFim) 
Balance 
Pediatrics Balance Scale (PDS) 
Soft Tissue Assessment 
Myoton PROÒ Device 
Gait Analysis 
FreeMedÒ 
Balance in Daily Living Activities 
PedaloÒ Balance Device 
 
Functional level will be defined with ‘Gross Motor Functional Classification System 
(GMFCS), spasticity with 'Modified Ashworth Scale', lower extremity joint range of motion 
(ROM) with ‘goniometer', gross motor functions with ‘Gross Motor Function Measure 
(GMFM-88)’, the functional strength of the body, its postural control and the nature of the 
trunk movements with ‘Trunk Impairment Scale’, functional independency for activities in 
children with ‘The Functional Indepence Measure for Children (WeeFim)’, the balance with 
an assessment tool adapted from the Berg Balance Scale (BDS) for the children in daily living 
activities ‘Pediatric Balance Scale (PDS)’, superficial skeletal muscles, connective tissues 
such as tendons and ligaments and other soft tissues with ‘Myoton®PRO Digital Palpation 
Device’, gait analysis with ‘FreeMed® (Sensör Medica)’ and the balance during sitting and 
standing positions with ‘Pedalo Balance Device’.  
 
Treatment Program 
The participants in the study will be rehabilitated in Bulgurlu Unimpeded  Life Center 
twice a week for 16 weeks in total (Duration of one session is 45 minutes). 
Group I (Control Group) will receive individual Neurodevelopmental (NDT) based 
rehabilitation program. 

 
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Group II (Study Group) will receive individual NDT based rehabilitation program (25 
minutes) + Simulated Hippotherapy System (20 minutes). 
 
Simulated Hippotherapy System Training Protocol 
In addition to the 25-minute neurodevelopmental treatment program, a 20-minute 
simulated hippotherapy system will be used. Programs that can be controlled by software and 
prepared according to the needs of the participants will be used. The simulated horse will be 
directed to reveal the contraction in the desired area. It is aimed to increase the strength of the 
desired muscles and to improve the body control, relaxation of muscles. EMG will be used to 
monitor how the muscles respond to action. 
 
Neurodevelopmental Therapy (NDT) Based Rehabilitation 
In accordance with the needs of the patients for their gross motor functions, the 
children in both groups were included in the NDT program, which was determined according 
to the age, sex, mental status and preferences of the individual. NDT program will include; 
rehabilitation of muscle tonus disorders, sensory-perception-motor integrity enhancement, 
exercises to increase extremity functions and body control, stretching and strengthening 
exercises due to muscular tightness and weakness, exercises to accommodate movements in 
daily life, and training of activities such as standing up,  walking, body care. 
 
 
 
 
 
 
 
 
 
 

 
7 
 
 
 
 
 
Development of Simulated Hippotherapy System and Investigation of the 
Effectiveness in Children with Cerebral Palsy 
 
 
 
 
 
Statistical Analysis Plan (SAP)  
 
(Pages 7 – 8)  
 
 
 
 
 
 
 
 
 
 
February 28, 2019 

 
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Statistical Analysis Plan (SAP) 
The statistical program Statistical Package for Social Sciences (SPSS) Version 11.5 
(SPSS Inc., Chicago, IL, USA) will be used in the data analysis of the study. The p value of 
p<0.05 will be considered to be statistically significant in the data analysis. One sample 
Kolmogorov-Smirnov test will be used to investigate the appropriateness of the variables to 
normal distribution. 
 
Intra-group analysis of the evaluation parameters that conform to the normal 
distribution will be done by Paired t-test and the intergroup analysis will be done by 
Independant t-test. Wilcoxon t-test will be used for intragroup analysis of parameters that do 
not comply with normal distribution, and Mann Whitney-U Test will be used for intergroup 
analysis. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Development of Simulated Hippotherapy System and Investigation of the 
Effectiveness in Children with Cerebral Palsy 
 
 
 
 
 
Informed Consent Form (ICF) 
 
(Pages 9 – 14)  
 
 
 
 
 
 
February 28, 2019 
 
 
 
 
 

 
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Informed Consent Form (ICF) 
Description of the Physiotherapist 
This study, if you accept your child to be participated, is a scientific research and it is 
titled as “Development of Simulated Hippotherapy System and Investigation of the 
Effectiveness in Children with Cerebral Palsy”. In this study, functional level will be defined 
with ‘Gross Motor Functional Classification System (GMFCS), spasticity with 'Modified 
Ashworth Scale', lower extremity joint range of motion (ROM) with ‘goniometer', gross 
motor functions with ‘Gross Motor Function Measure (GMFM-88)’, the functional strength of 
the body, its postural control and the nature of the trunk movements with ‘Trunk Impairment 
Scale’, functional independency for activities in children with ‘The Functional Indepence 
Measure for Children (WeeFim)’, the balance with an assessment tool adapted from the Berg 
Balance Scale (BDS) for the children in daily living activities ‘Pediatric Balance Scale 
(PDS)’, superficial skeletal muscles, connective tissues such as tendons and ligaments and 
other soft tissues with ‘Myoton®PRO Digital Palpation Device’, gait analysis with 
‘FreeMed® (Sensör Medica)’ and the balance during sitting and standing positions with 
‘Pedalo Balance Device’. The study, which is planned to last in 16 weeks, requires 
participants to attend the study regularly for twice a week and each day for one session which 
is 45 minutes. There will be no disruption of the body during the process.  
This research will be carried out by Neslihan KARABACAK, PT (Tel: +90 534 747 
4980), Canan Günay YAZICI, PT, MSc (Tel: +90 538 460 1249) and will be under the 
supervision of Zübeyir SARI, PT, MSc, PhD, Assoc. Prof. at Marmara University, Institute of 
Health Sciences, Department of Physiotherapy and Rehabilitation.  
Your child is being invited to a research project. It is very important for you to 
understand why and how this research will be done before making a decision. Please take 
some time and read the following informations carefully, discuss it with others if you wish. If 
you have an unclear section or need more detailed information, you can get information from 
us. You are invited to our research because we think your child matches the criterias to be 
included. We would like to note that participation is voluntary and that refusal to participate 
does not lead to any penalty or loss of any benefit. In the same way, you can withdraw from 
the research at any time.  
 

 
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After getting the demographic information of the participants, the upper extremity 
functions will be measured by the above physiotherapist and with the mentioned tests. The 
evaluation tests will be repeated 3 times throughout the treatment. The data obtained from the 
assessments will be recorded in the computer and the changes during pre- and post-treatment 
will be analyzed. The assessments applied to the participants in our research do not have any 
known harm. In the event of any unexpected damage in the evaluation process or during the 
rehabilitation process, the information will be given immediately to you. In case of any 
damage to the participants, the necessary applications shall be covered by the researchers 
without any recourse. For this, you will not be charged any fees, neither you nor your social 
security insurance. 
While participation in the research does not help you immediately, it is hoped that our 
research results will have benefits for the organization, society or science in the future. You 
will not be charged any fees for the purposes of the research or for the social security 
institution to which you are affiliated. 
 
Consent of the Participant  
I have read the entire information form clearly and understood or because I do not 
know how to read/not able to or do not understand the language it was read or translated to 
me. I was given the opportunity to ask, evaluate and decide on my health status both during 
and after my application and when filling this form in. All kinds of treatment and diagnostic 
alternatives, including the possibility of not getting the treatment, their risks and dangers are 
explained. 
 
Name and the Surname of the Participant and Legal Representative: 
 
Date:   
 
 
 
 
 
 
Signature: 
 
Name and Surname of the Withness: 
Date:   
 
 
 
 
 
 
Signature: 
  

 
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Declaration of the Physiotherapist 
I gave the patient the necessary information about the study and the procedures to be 
performed. I believe that the patient understood this information, asked me the questions that 
she/he wanted to ask, and accepted the process with her/his free will. 
 
Researcher: Physiotherapist Neslihan KARABACAK 
Address: Marmara University, Institute of Health Sciences, Department of 
Physiotherapy and Rehabilitation- Başıbüyük  . Maltepe /Istanbul/TURKEY 
Mobile Phone: +90 534  747 4980                     E-mail: neslikarabacak@gmail.com 
Date:   
 
 
 
 
      Signature: 
 
Researcher: Physiotherapist Canan GÜNAY YAZICI 
Address: Marmara University, Institute of Health Sciences, Department of 
Physiotherapy and Rehabilitation - Başıbüyük  . Maltepe/Istanbul/TURKEY 
Mobile Phone: +90 538 460 1249            E-mail: cnngnyzc@gmail.com @gmail.com 
Date:   
 
 
 
 
      Signature: 
 
 
 
 
 
 
 
 
 
 
 

 
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Declaration of the Participant / Legal Representative  
I understand that a medical research will be carried out and the above information 
about this research was explained to me. I know my child is invited to this research as a 
participant. If I participate in this research, I believe that the confidentiality of the information 
of my child during research will be treated with great care and respect. I was given enough 
information that my child's personal information would be protected with care during the use 
of the research and the results will only used for educational and scientific purposes. During 
the research I can withdraw my child from the study at any time without any cause (But in 
that case I am aware of the difficult situation it would cause to the reaseachers if I do not give 
any notice). I don't take any financial responsibility for the research expenses. There will be 
no payment for me. Whether directly, indirectly arised any health problem that may occur 
during the research, I will not undergo any monetary burden. When we encounter any health 
problem during the research; at any hour, I know I can call my physiotherapist. My child does 
not have to be participated in this research or may not participate. We have not experienced 
any compelling behavior to participate in the research. If we refuse to participate, I know that 
this will not bring any harm to our medical care and our relationship with my 
physiotherapist.I have understood all the explanations made to me in detail. At the end of a 
certain period of thinking on my own, I decided that my child could take part in this research 
project as a participant. On behalf of my child, I accept this invitation voluntarily. 
I have read the text above which shows the information that should be given to the volunteer 
before investigating. These were written and was explained verbally. With these conditions, I 
agree to participate in this research without any pressure or compulsion on me and my child. 
A signed 2 copies of this form, which consists of 4 pages, a copy of the documents will be 
given to me. 
Name and the Surname of the Participant and Legal Representative: 
 
Date:   
 
 
 
 
 
 
Signature: 
 
Name and Surname of the Withness (who have witnessed the process of receipt until 
the end): 
Date:   
 
 
 
 
 
 
Signature: 

 
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The researcher who made the explanations, 
Researcher: Physiotherapist  Neslihan Karabacak 
Address: Marmara University, Institute of Health Sciences, Department of 
Physiotherapy and Rehabilitation - Başıbüyük  . Maltepe/Istanbul/TURKEY 
Mobile Phone: +90 534  747 4980                       E-mail: neslikarabacak@gmail.com 
Date:   
 
 
 
 
      Signature: 
 
Researcher: Physiotherapist Canan GÜNAY YAZICI 
Address: Marmara University, Institute of Health Sciences, Department of 
Physiotherapy and Rehabilitation - Başıbüyük  . Maltepe/Istanbul/TURKEY 
Mobile Phone: +90 538 460 1249              E-mail: cnngnyzc@gmail.com @gmail.com 
Date:   
 
 
 
 
      Signature: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
15
 
 
 
 
 
Development of Simulated Hippotherapy System and Investigation of the 
Effectiveness in Children with Cerebral Palsy 
 
 
 
 
 
Annex 
 
(Pages 15 – 25)  
 
 
 
 
 
 
February 28, 2019 
 

 
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Annex 1. Marmara University Faculty of Medicine Clinical Researches Ethics 
Committee Approval (Approval made at the meeting on 07.04.2018 with number: 
09.2017.297) 
 

 
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Annex 2. Participants Tracking Form 
No. 
                                      Date. 
Name-Surname 
                                         
 
Adress 
 
 
Phone 
 
Gender 
Female       Male 
Age  
 
Height  
 
Weight  
 
CP Type 
Hemiparetic                Diparetic                    Quadriparetic 
GMFCS Level  
I                              II                                  III 
Education Level 
 
Having surgery/date 
 
Botulinum toxin injections 
and date of apply  
 
Auxiliary tool use 
 
Orthesis / device use 
 
History of any disease / 
trauma 
 
Any drug use at the 
moment? 
 
 
RANGE OF MOTİON 
MEASURE   
BEFORE 
WEEK 8 
WEEK 16 
LEFT 
RIGHT 
LEFT 
RIGHT 
LEFT 
RIGHT 
Hip flexion 
 
 
 
 
 
 
Hip extansion 
 
 
 
 
 
 
Hip internal rotation 
 
 
 
 
 
 
Hip external rotation 
 
 
 
 
 
 
Hip abduction 
 
 
 
 
 
 
Hip adduction 
 
 
 
 
 
 
Knee flexion 
 
 
 
 
 
 
Knee extansion 
 
 
 
 
 
 
Dorsi flexion 
 
 
 
 
 
 
Plantar flexion 
 
 
 
 
 
 
 

 
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Modified Ashworth Scale 
MEASURE   
BEFORE 
WEEK 8 
WEEK 16 
LEFT 
RIGHT 
LEFT 
RIGHT 
LEFT 
RIGHT 
Hip adduction 
 
 
 
 
 
 
Hamstring 
 
 
 
 
 
 
Gastrocnemius  
 
 
 
 
 
 
Soleus 
 
 
 
 
 
 
 
Myoton®PRO Digital Palpation Device  
MEASURE   
BEFORE 
WEEK 8 
WEEK 16 
LEFT 
RIGHT 
LEFT 
RIGHT 
LEFT 
RIGHT 
Hip flexion 
 
 
 
 
 
 
Hip adduction 
 
 
 
 
 
 
Hamstring 
 
 
 
 
 
 
Quadriceps 
 
 
 
 
 
 
Gastroknemius  
 
 
 
 
 
 
Soleus 
 
 
 
 
 
 
 
Modified Ashworth Scale (Please mark) 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Gross Motor Functional Classification System (GMFCS) (Please mark) 
 
 
 
 
 
 
 
 

 
20
Trunk Impairment Scale (Please mark) 
 
 
 
 
 
 

 
21
 
 
 

 
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Pediatric Balance Test (Please mark) 
All items are scored between 0 and 4 and the total score is calculated. 
 
The Functional Indepence Measure for Children (WeeFim) (Please mark) 
 
7 = Fully independent 
6 = Modified independent 
Unaided 
5 = Surveillance is required 
4 = Minimal aid (75% of children) 
3 = Moderate help (50% of children) 
Helped / Modified Dependent 
2 = Maximum help (25% of children) 
1 = Full help (<less than 25% of children do) 
Totally Dependent 
 

 
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Gross Motor Functıon Measure-88 (Please mark) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
24
 
 
 

 
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