The Effects of a Hippotherapy Simulator in Children With Cerebral Palsy
Phase: NA
Conditions: Rehabilitation, Cerebral Palsy, Spastic
Sponsor: Marmara University

 
 
 
 
  
The Effects of a Hippotherapy Simulator in Children 
with Cerebral Palsy 
 
 
Study Protocol with Statistical Analysis Plan (SAP) and 
Informed Consent Form (ICF) 
 
 
 
 
 
 
 
January 11, 2018 
 

2 
 
 
 
The Effects of a Hippotherapy Simulator in Children 
with Cerebral Palsy 
 
 
Study Protocol  
 
(Pages 2 – 6) 
 
 
 
 
 
 
 
 
January 11, 2018 
 
 

3 
 
Study Protocol  
The study titled "The Effects of a Hippotherapy Simulator in Children with Cerebral 
Palsy” was approved by the Marmara University Faculty of Medicine Clinical Researches 
Ethics Committee meeting on 02.09.2016 with approval number: 09.2016.478 (Annex-1). 
This study was conducted in “The Private Dilbade Special Education and 
Rehabilitation Center”  between 14.12.2016 and 28.10.2017 with 30 children with spastic 
Cerebral Palsy (CP) who agreed to participate in the study. 
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 by 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 by the 
Declaration of Helsinki. 
The hypothesis of the Study 
H0: Addition of the exercises performed with Hippotherapy Simulator (HS) device to 
the Neurodevelopmental Therapy (NDT) based rehabilitation program in children with CP does 
not contribute positively in improving the efficiency of gross motor functions, lower extremity 
functions, muscle tone and spasticity, trunk control, sitting and standing balance, walking 
functions and functional independence. 
H1: Addition of the exercises performed with HS device to the NDT based 
rehabilitation program in children with cerebral palsy contributes positively to improve the 
efficiency of gross motor functions,  lower extremity functions, muscle tone and spasticity, 
trunk control, sitting and standing balance, walking functions and functional independence. 
 
Randomization of the Study Groups 
Children with CP who received rehabilitation services in “The Private Dilbade Special 
Education and Rehabilitation Center” were invited to participate in the study. Two different 
treatment methods were applied to the children who volunteered to participate and met the 
participation criteria. Rehabilitation programs based on individual NDT were applied to the 
children included in the study for eight weeks (first group). In the next eight weeks, the HS 

4 
 
system was applied to the same children in addition to individual NDT based rehabilitation 
programs (study group). 
Inclusion Criteria 
•    Having a diagnosis of Spastic CP, 
• 
Children aged between 5 - 18 years, 
• 
GMFCS level is I, II or III, 
• 
Independent seating, 
• 
Walking with at least 10 meters of independent, orthotic and/or auxiliary device, 
• 
Can understand simple verbal instruction, 
• 
Those with hip adductor muscle spasticity level less than 2 according to MAS, 
• 
Having bilateral passive hip abduction enough to could sit into the hippotherapy 
simulator device, 
• 
Voluntarily agreed to participate in the study. 
 
Exclusion Criteria 
• 
Those with hip dislocation, 
• 
Severe contracture or deformity to prevent the study, 
• 
Advanced scoliosis (above 20 degrees), 
• 
Acute uncontrolled acute seizures, 
• 
Uncontrollable severe epileptic attacks, 
• 
Visual and auditory problems, 
• 
Injection of botulinum toxin in the last 6 months patients, 
• 
Underwent surgical operation such as muscle relaxation, tendon extension and 
selective dorsal rhizotomy in the last 6 months. 
 
Applied Evaluations 
Evaluations were applied three times: before treatment, after individual NDT programs 
(at the end of the 8th. week), and after NDT + HS  application (at the end of the 16th week).  
All evaluation data were noted to the "Participant Tracking Form” (Annex-2).  
Functional levels of participants were evaluated with the “Gross Motor Function 
Classification System” (GMFSS). Gross motor functions with “Gross Motor Function Measure-

5 
 
88” (GMFM-88); lower extremity joint range of motion (ROM) with “universal goniometer”; 
muscle tones and spasticity with “Modified Ashworth Scale” (MAS) and “Myoton®PRO 
Digital Palpation Device” was evaluated.  
“The Trunk Impairment Scale” (TIS) was used to assess the functional strength of the 
body, its postural control and the nature of the trunk movements. The Pediatric Balance Scale 
(PBS), an assessment tool adapted from the Berg Balance Scale (BBS), was used to assess 
children's functional and dynamic balances in daily life activities. Besides, the Pedalo® 
Sensamove Balance Test device was used to evaluate the dynamic balance of children in sitting 
and standing positions. The Functional Independence Measure (WeeFIM) for children was used 
to assess children's functional independence in daily activities. Win-Track (Medicapteurs, 
France) path and software system was used to evaluate the walking functions (Spatio-temporal 
parameters) of children. 
Treatment Program 
The participants were selected for the rehabilitation program in “The Private Dilbade 
Special Education and Rehabilitation Center” twice a week for 16 weeks (duration of one 
session is 45 minutes). 
Firstly, children participating in the study were included in the rehabilitation program 
using only the NDT approach for 16 sessions (8 weeks x 2 days x 45 minutes). 
Then, the same children were taken into a rehabilitation program in which 16 sessions 
(8 weeks x 2 days a week) the HS device (30 minutes) and NDT (15 minutes) (HS + NDT 
method) were used together. 
 
        Hippotherapy Simulator System Protocol 
Horse Riding Simulator (HRS) device was used as a hippotherapy simulator device. 
HRS is a simulator consisting of a seat (saddle), control panel, foot pedals, and hand grip, and 
has four different speed programs (warm-up, level 1-2-3). HRS is a device that moves forward, 
backward, backward-to-back, right-to-left swing and up-and-down swing in 3 dimensions, 
similar to the movements of a real horse, forming an 8-shaped movement on five axes. After 
the children sat in the saddle section, they were first taken to the warm-up speed program for 5 
minutes, then to another one of the other speed levels (gradually moved to other speed levels 

6 
 
as appropriate for the development and tolerance of children) and finally to the warm-up speed 
program for 5 minutes. 
        Neurodevelopmental Therapy Based  Rehabilitation 
 NDT rehabilitation program was determined according to the children's level of gross 
motor function, age, gender, mental state, and preferences.  
 NDT program consists of the rehabilitation of muscle tone disorders, increasing 
sensory-perception-motor integrity, exercises to increase limb functions and body control, 
stretching and strengthening exercises for muscle shortness and weakness, exercises that 
include movements in daily life and training activities such as standing, walking, body care. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

7 
 
 
 
The Effects of a Hippotherapy Simulator in Children 
with Cerebral Palsy 
 
 
 
 
 
Statistical Analysis Plan (SAP)  
 
(Pages 7 – 8)  
 
 
 
 
 
January 11, 2018 
 
 

8 
 
Statistical Analysis Plan (SAP) 
For the data analysis of our research, an 11.5 version of the statistical program "SPSS 
(Statistical Package for Social Science) for Windows" was used in the computer environment. 
With the statistical program, 95 percentage confidence interval and significance were evaluated 
at p <0.05 level. 
The conformity of the data to normal distribution was analyzed with the "Kolmogorov 
Smirnov" test. In the Kolmogorov Smirnov test, it was decided that the distributions did not 
conform to the normal distribution, since p <0.05 and histogram graphics were skewed. For this 
reason, analyzes were performed using nonparametric statistical methods. 
"Friedman Test (variance analysis in repetitive measurements)" was used to compare 
the evaluations made after the initial, NDT approach and after the HS + NDT method, and to 
compare the changes between the results obtained. The pairwise comparisons of the changes in 
the evaluation results obtained after the Friedman test were analyzed with the "Wilcoxon 
signed-rank test". Bonferonni correction was made after the Friedman test. As a result, the 
significance value of 0.05 was divided by 3 and the new significance value was determined as 
0.016. 
 
 
 
 
 
 
 
 
 
 
 
 
 

9 
 
 
 
 
 
The Effects of a Hippotherapy Simulator in Children 
with Cerebral Palsy 
 
 
 
 
 
 
Informed Consent Form (ICF) 
 
(Pages 9 – 13)  
 
 
 
 
January 11, 2018 
 
 

10 
 
Informed Consent Form (ICF) 
Description of the Physiotherapist 
This study, which your child will participate in, is scientific research and is called “The 
Effects of a Hippotherapy Simulator in Children with Cerebral Palsy”. This study aims to 
research the effect of simulated hippotherapy to correct problems related to standing and sitting 
balance, gait, trunk involvement, and functionality of your lower limbs in children with spastic 
cerebral palsy. 
The research will be carried out by R.A Pt. Canan GÜNAY YAZICI (Tel: +90 538 
460 12 49), under the supervision of Zübeyir SARI, Ph.D., Assoc. Prof. Dr., Marmara 
University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation, as a 
master thesis at “The Private Dilbade Special Education and Rehabilitation Center”. 
If you agree to participate in the study, your child will be taken to a 16-week 
physiotherapy and rehabilitation program by physiotherapists. After socio-demographic 
information about you and your child is obtained before the treatment program, your child's 
gross motor functions, angle measurements of the lower extremity joints and muscle tone, gait 
analysis, trunk affection, balance, and daily functions will be evaluated. After the first 
evaluation, your child will be taken to the 8-week neurodevelopmental treatment program that 
is routinely applied. After this program is over, your child will be included in the hippotherapy 
simulator treatment that mimics the movements of a real horse in addition to the 
neurodevelopmental treatment program. Initial assessments will be repeated at the end of the 
8th week and 16th week of the rehabilitation. Your responsibilities regarding this research are 
to pay attention to your sessions and to follow the suggestions. You should regularly attend a 
45-minute session 2 days a week for this study, which is planned to last 16 weeks. 
Your child is being invited to a research project. You need to understand why and how 
this research will be done before making a decision. Please take some time and read the 
following pieces of information 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 criteria 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. 

11 
 
All your medical and identification information about you and your child will be kept 
confidential and your identity information will not be provided even if the research is published, 
but the audience of the research, the attendants, ethical committees and government authorities 
can access your medical information when necessary. When you want, you can access medical 
information about yourself and your child. 
The evaluation methods and treatment programs to be applied in our study have no 
known harm or risk. In this regard, you and your child can be safe and comfortable. In case of 
any unexpected damage during the evaluation and rehabilitation process, you will be informed 
immediately. In case of any damage to the participants, the necessary applications will be 
covered by the researchers without any resources. 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. No fee 
will be charged for this study from you or the social security institution to which you are 
affiliated. 
 
Consent of the Participant  
I have read this entire written document. Since I don't know reading/language, it was 
understandably read and explained or translated to me. I was allowed to ask, evaluate and make 
decisions about my child's health status during and after my application and while filling out 
this form. All kinds of treatment, diagnosis, and alternatives including risks and dangers of 
treatment were explained. After all these explanations told to me and my child, I accept this 
invitation for scientific research with my consent.  
 
Name and the Surname of the Participant and Legal Representative: 
 
Date:   
 
 
 
 
 
 
Signature: 
 
Name and Surname of the Withness: 
Date:   
 
 
 
 
 
 
Signature: 

12 
 
 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 Canan GÜNAY YAZICI 
Address: Marmara University, Institute of Health Sciences, Department of 
Physiotherapy and Rehabilitation - Başıbüyük Maltepe/Istanbul/TURKEY  
Mobile Phone: +90 538 460 12 49            E-mail: cnngnyzc@gmail.com  
Date:   
 
 
 
       Signature: 
 
Declaration of the Participant / Legal Representative  
Ms. Canan GÜNAY YAZICI said that medical research would be conducted and 
explained the above information about this research to me. I know that my child is invited to 
this research as a participant. If I participate in this research, I believe that the confidentiality 
of my child's information will be handled with great care and respect during the research. 
During the conduct of the study, information was provided that my child's personal information 
would be carefully protected. I also know that this information will only be used for educational 
and scientific purposes. During the research, I can withdraw from work at any time without any 
reason (However, in this case, I am aware of the difficult situation that the researchers will 
cause if I do not report anything). I do not take any financial responsibility for the research 
costs. There will be no payment for me. I will not be exposed to any monetary burden in any 
health problem that may arise directly or indirectly during the research. When we encounter 
any health problems during the research; I know that I can call the physiotherapist Canan 
GÜNAY YAZICI on an hour from +90 538 460 120 49 (mobile) phone. 
We did not experience any compulsive behavior to participate in the research. I know 
that if we refuse to participate, this will not harm our current treatment and our relationship 
with the physiotherapist. 
I understood all the explanations made to me in detail. At the end of a certain thinking 
period, I decided that my child could participate in this research project as a participant. I 
voluntarily accept this invitation on behalf of my child. 
 

13 
 
Voluntary Approval Form 
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 copy of this four-page form 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: 
 
The researcher who made the explanations, 
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 12 49             
E-mail: cnngnyzc@gmail.com  
Date:   
 
 
 
 
Signature: 
 
 
 
 
 
 

14 
 
Annex 1. Marmara University Faculty of Medicine Clinical Researches Ethics 
Committee Approval (Approval made at the meeting on 02.09.2016 with approval number: 
09.2016.478)  
 
 

15 
 
Annex 2. Participants Tracking Form 
 
No. 
                                      Date. 
Name-Surname 
                                         
 
Address 
 
 
Phone 
 
Gender 
Female                    Male     
               Age  
Height  
                                                           Weight  
CP Type 
Hemiparesis                Diparesis                    Quadriparesis  
GMFCS Level  
I                              II                                  III 
Education Level 
 
Having surgery/date 
 
Botulinum toxin 
injections./date  
 
Auxiliary tool used 
 
Orthotic/device used 
 
 
PASSIVE RANGE OF MOTION 
MEASURE   
BEFORE 
8. WEEKS 
16.WEEKS 
LEFT 
RİGHT 
LEFT 
RİGHT 
LEFT 
RİGHT 
Hip flexion 
 
 
 
 
 
 
Hip extension 
 
 
 
 
 
 
Hip internal rotation 
 
 
 
 
 
 
Hip external rotation 
 
 
 
 
 
 
Hip abduction 
 
 
 
 
 
 
Hip adduction 
 
 
 
 
 
 
Knee flexion 
 
 
 
 
 
 
Knee extension 
 
 
 
 
 
 
Dorsiflexion 
 
 
 
 
 
 
Plantar flexion 
 
 
 
 
 
 
Trunk lateral flexion 
 
 
 
 
 
 
Trunk flexion 
 
 
 
 
 
 
Trunk extension 
 
 
 
 
 
 

16 
 
MODIFIED ASHWORTH SCALE 
MEASURE   
BEFORE 
8. WEEKS 
16.WEEKS 
LEFT 
RİGHT 
LEFT 
 
LEFT 
RİGHT 
Hip flexion 
 
 
 
 
 
 
Hip abduction 
 
 
 
 
 
 
Hamstring 
 
 
 
 
 
 
Quadriceps 
 
 
 
 
 
 
Gastrocnemius  
 
 
 
 
 
 
Soleus 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MYOTON®PRO DIGITAL PALPATION DEVICE 
MEASURE   
BEFORE 
8. WEEKS 
16.WEEKS 
LEFT 
RİGHT 
LEFT 
 
LEFT 
RİGHT 
Hip flexion 
 
 
 
 
 
 
Hip adduction 
 
 
 
 
 
 
Hamstring 
(semitendinosus, biceps 
femoris) 
 
 
 
 
 
 
Quadriceps (rectus 
femoris, vastus lateralis, 
vastus medialis) 
 
 
 
 
 
 
Gastrocnemius  
 
 
 
 
 
 
Soleus 
 
 
 
 
 
 

17 
 
GROSS MOTOR FUNCTIONAL CLASSIFICATION SYSTEM (GMFCS) 
 
Level of the participant:  
 
 
 
 
 
 
 

18 
 
THE TRUNK IMPAIRMENT SCALE  
 
 
 
 
 
 

19 
 
 
 
 
 

20 
 
PEDIATRIC BALANCE TEST 
All items are scored between 0 and 4 and the total score is calculated. 
 
THE FUNCTIONAL INDEPENDENCE MEASURE (WEEFIM) (WEE-FIM) 
 
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 
 

21 
 
GROSS MOTOR FUNCTION MEASURE-88 
 

22 
 
 
 

23