Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions
Conditions: Cerebral Palsy
Sponsor: Dilara Merve Sarı

 
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Investigation of the Effectiveness of Visual Feedback 
Training on Upper Extremity Functions in Cerebral Palsy 
 
 
 
 
Study Protocol with Statistical Analysis Plan (SAP) and 
Informed Consent Form (ICF) 
 
 
 
 
 
 
 
 
 
 
 
 
January 1, 2018 
 
 
 

 
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Investigation of the Effectiveness of Visual Feedback 
Training on Upper Extremity Functions in Cerebral Palsy 
 
 
 
 
Study Protocol  
 
(Pages 2 – 6) 
 
 
 
 
 
 
 
 
 
 
 
January 1, 2018 
 
 
 
 

 
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Study Protocol  
 
Study titled ‘Investigation of the Effectiveness of Visual Feedback Training on Upper 
Extremity Functions in Cerebral Palsy was approved by Marmara University Faculty of 
Medicine Clinical Researches Ethics Committee meeting on 05.01.2018 with approval 
number: 09.2018.007 (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 Cogniboard Light Trainer device to the 
neurodevelopmental (NDT) based rehabilitation program in patients with cerebral palsy does 
not contribute positively in improving the efficiency of upper extremity functions. 
 
H1: Addition of the exercises performed with Cogniboard Light Trainer device to the 
neurodevelopmental (NDT) based rehabilitation program in patients with cerebral palsy 
contributes positively to improve the efficiency of upper extremity functions. 
 
Randomization of the Study Groups 
 
Children with Cerebral Palsy who applied to the Dilbade Education and Rehabilitation 
Center for rehabilitation were invited to participate to 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 both groups. The Cogniboard Light 
Trainer education system was added to the rehabilitation program of the Group II (the study 
group). 

 
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Inclusion Criteria 
 
• Volunteered to participte, 
• The child and the family have agreed to participate in the study, 
• Having a diagnosis of Cerebral Palsy, 
• Children aged between 4 - 18 years, 
• Having upper extremity spasticity (0), (1), (1+) according to the modified Ashworth Scale 
(MAS)  
• To be able to cooperate to the exercises 
 
Exclusion Criteria 
 
• Botulinum Toxin (BOTOX) injection applied to the upper extremity within the last 6 months, 
• Congenital deformity in upper extremity 
• Epileptic attack history, 
• Any cardiac or orthopedic problem, 
• Visual or hearing impairement  
 
Applied Evaluations 
 
Evaluations are applied twice: before and after the study. All evaluation data are noted 
to ‘Participants Tracking Form’ (Annex-2). Spasticity was defined with 'Modified Ashworth 
Scale'; upper extremity joint range of motion (ROM) with ‘goniometer'; grip and pinch strength 
with ‘dynamometer'; hand skills with 'Minnesota Hand Skill Test'; functional abilities with 
'Childhood Health Assessment Questionnaire (CHAQ) and functional level with ‘Gross Motor 
Function Classification System (GMFCS)’ 
 
Treatment Program 
 
The participants in our study were all rehabilitated in Dilbade Education and 
Rehabilitation Center twice a week for 8 weeks, a total of 16 sessions (Duration of one session 
is 45 minutes). 
 

 
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Group I (Control Group) received individual Neurodevelopmental (NDT) based 
rehabilitation program.  
 
Group II (Study Group) received individual NDT based rehabilitation program (35 
minutes) + Cogniboard Light Trainer education (10 minutes). 
 
Cogniboard Light Trainer Education Protocol 
 
Upper limb exercises were applied to the study group with the device which is a training 
program with visual feedback for 10 minutes in addition to individual 35 minutes 
neurodevelopmental treatment program. Devices were placed in the mirror so that the 
participants could see their own reflection. The distances of the participants to the mirror were 
proportional to their height. For children between 100-149 cm, the distance of the child with 
the mirror was set as 40 cm and for the children between 149-175 cm, 50 cm. Eight devices 
were placed in the mirror within the reach of the participant. While the shoulder and wrist were 
flexed, the shoulder was placed in the lateral distances that the shoulder could reach while the 
shoulder was in 90°, while the shoulder was in extension and the other devices were placed 
between these points (Picture 1). 
 
(Picture 1. Application of Cogniboard® Light Trainer Education Device) 

 
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Neurodevelopmental Therapy (NDT) Based Upper Extremity 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 included; rehabilitation of 
muscle tonus disorders, sensory-perception-motor integrity enhancement, exercises to increase 
upper extremity functions, stretching and strengthening exercises due to muscular shortness 
and weakness, exercises to accommodate movements in daily life, and training of activities 
such as standing up, eating, walking, body care. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Investigation of the Effectiveness of Visual Feedback 
Training on Upper Extremity Functions in Cerebral Palsy 
 
 
 
 
Statistical Analysis Plan (SAP)  
 
(Pages 7 – 8)  
 
 
 
 
 
 
 
 
 
 
 
 
January 1, 2018 
 
 

 
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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) was used in the data analysis of the study. The p value of  
p<0.05 was considered to be statistically significant in the data analysis. Shaphiro-Wilks test 
was used to investigate the appropriateness of the variables to normal distribution. 
 
In the comparison of the nominal characteristics of the participants in both groups, 
such as gender, CP type, GMFCS and dominant side, Fisher Precise Chi-Square Test was 
used. 
 
The initial demographic characteristics such as age, height, weight, body mass index 
(BMI) of the participants in both groups and the changes before and after the treatment were 
compared with Independent Samples t-Test and  Paired Samples t-Test. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Investigation of the Effectiveness of Visual Feedback 
Training on Upper Extremity Functions in Cerebral Palsy 
 
 
 
 
 
Informed Consent Form (ICF) 
 
(Pages 9 – 13)  
 
 
 
 
 
 
 
 
 
January 1, 2018 
 
 
 
 
 

 
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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 ‘Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity 
Functions in Cerebral Palsy’. In this study, individuals with Cerabral Palsy will be evaluated in 
terms of upper extremity (arm) functions, upper extremities’ joint range of motion with 
universal goniometer, gripping force with dynamometer, pinching force with pinchmeter, 
spasticity will be defined with Modified Ashworth Scale (MAS),  hand skills with 'Minnesota 
Hand Skill Test'; functional abilities with 'Childhood Health Assessment Questionnaire 
(CHAQ) and functional level with ‘Gross Motor Function Classification System (GMFCS)’. 
The study, which is planned to last in 8 weeks, requires participants to attend the study regularly 
for 2 days 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 Physiotherapist Dilara Merve SARI (Tel: 0533 344 
46 01) and will be under the supervision of Assoc. Prof. Dr. Tuğba KURU ÇOLAK 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 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.  
 
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 2 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. 

 
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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 Dilara Merve Sarı 
Address: Dilbade Education and Rehabilitation Center – Silahtaraga, 129 34050 Eyup / 
Istanbul / Turkey 
Mobile Phone: +90 533 344 46 01                      E-mail: dilaramervesari@gmail.com 
Date:   
 
 
 
 
      Signature: 
 
Declaration of the Participant / Legal Representative  
 
Ms. Dilara Merve SARI stated 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 physiotherapist Dilara 
Merve SARI from +90 533 344 46 01 (mobile).  
 
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. 

 
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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. 
 
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 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: 
 
The researcher who made the explanations, 
Researcher: Physiotherapist Dilara Merve Sarı 
Address: Dilbade Education and Rehabilitation Center – Silahtaraga, 129 34050 Eyup / 
Istanbul / Turkey 
Mobile Phone: +90 533 344 46 01                      E-mail: dilaramervesari@gmail.com 
Date:   
 
 
 
 
      Signature: 
 
 
 
 
 
 
 
 

 
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Annex 1. Marmara University Faculty of Medicine Clinical Researches Ethics Committee 
Approval (Approval made at the meeting on 05.01.2018 with number: 09.2018.007) 
 
 
 

 
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Annex 2. Participants Tracking Form 
 
Participant's Name - Surname: 
Legal Representative Name - Surname: 
Phone number: 
Age / Gender:  
 
 
Height:  
 
 
Weight: 
Date of birth: 
Type of Cerebral Palsy (CP) (Mark X):     Spastic  
Diskinetic  
  Ataxic 
Which side of the arm is effected mostly? 
Which side is your dominant side? 
How did the problem occur? (Preterm birth, after birth etc. Please explain.) 
 
 
How many years have you been going to a rehabilitation center? 
 
 
Did you have any operations? Please write if you did: 
 
 
Are you using any device? If so, what are theyt? 
 
 
Evaluations: 
Muscle Tone: (According to the Modified Ashworth Scale 0/1/1+/2/3/4) 
Right or Left Arm (Please mark) 
Hand Wrist Function: 
Elbow Flexion: 
Supination: 
 
Do you have any additional medical problems? 
Yes / What is it?:  
No: 
 
 

 
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Range of Motion: 
Before Treatment 
After Treatment 
Shoulder 
Flexion 
 
 
Abduction 
 
 
Elbow 
Flexion 
 
 
Front Arm 
Extension 
 
 
Supination 
 
 
Pronation 
 
 
Hand Wrist 
Flexion 
Extension 
 
Muscle Strength 
Before Treatment 
After Treatment 
Grasping 
 
 
Tip Pinch 
Lateral Pinch 
Triple Pinch 
 
Minnesota Hand Skill Test 
Before Treatment 
After Treatment 
Placement with the 
affected hand (sn) 
Placement bilaterally (sn) 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Gross Motor Functional Classification System (GMFCS) 
 
Level of the participant:  
 
 
 

 
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