The Effectiveness of Game-Based Virtual Reality Approach in Patients With Subacromial Impingement Syndrome
Phase: NA
Conditions: Shoulder Impingement Syndrome, Virtual Reality, Rehabilitation, Subacromial Impingement Syndrome
Sponsor: Marmara University

 
  
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The Effectiveness of Game-Based Virtual Reality Approach in Patients with 
Subacromial Impingement Syndrome  
  
  
  
  
  
  
Study Protocol and Statistical Analysis Plan (SAP) 
 
(Pages 1 - 20) 
  
  
  
  
  
  
 
 
  
April 8, 2019  
  
  
  

 
  
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The Effectiveness of Game-Based Virtual Reality Approach in Patients with 
Subacromial Impingement Syndrome  
  
 
 
 
  
  
Study Protocol 
 
(Pages 2 – 5) 
  
  
  
  
  
  
  
  
April 8, 2019  
  

 
  
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Study Protocol   
Study titled “The Effectiveness of Game-Based Virtual Reality Approach in Patients 
with Subacromial Impingement Syndrome” was approved by Marmara University Faculty of 
Health Sciences Ethical Committee at the meeting on 29.11.2018 with approval number: 36 
(Annex-1).  
The legal representatives of the patients who participated in the study will be informed 
about the aim, duration and the programs to be applied throughout the study. Volunteer 
Information Form will be signed and approved in accordance with the standards deemed 
appropriate by the Ethical Committee of Marmara University Faculty of Health Sciences. The 
study will be conducted in accordance with the Declaration of Helsinki.  
  
Hypothesis of the Study 
H0: Addition of game-based virtual reality exercises to the rehabilitation program in 
patients with subacromial impingement syndrome does not contribute positively in improving 
the effectiveness of upper extremity for pain, range of motion and disability 
H1: Addition of game-based virtual reality exercises to the rehabilitation program in 
patients with subacromial impingement syndrome contribute positively in improving the 
effectiveness of upper extremity for pain, range of motion and disability. 
  
Randomization of the Study Groups 
Individuals with Subacromial Impingement Syndrome applying to Cadde Medical 
Center for treatment will be invited to participate in the study. Individuals who volunteered to 
participate and whom met the criteria for participation will be randomized with simple random 
sampling method and will be divided into two groups. In both groups participants will receive 
conventional physiotherapy and rehabilitation. In the study group, 10 minutes of exercises with 
the game-based virtual reality exercises will added to the conventional physiotherapy and 
rehabilitation methods  
 
Inclusion Criteria  
• 
Volunteered to participate in the study, 
• 
Aged between 18-65 years 

 
  
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            Exclusion Criteria  
• 
Any visual or hearing problem,  
• 
Other neurological, orthopedic or rheumatic problems that may restrict 
shoulder motion or cause pain, 
• 
Having a physical disability or uncontrolled chronic systemic disease, 
• 
Major trauma, 
• 
Treatment for shoulder problems within the last 6 months, 
• 
History of epilepsy 
 
Evaluations  
A Physiotherapist will applying the following evaluation parameters at the baseline, and 
at the end of 4-weeks treatment program, the same physiotherapist will be applying evaluation 
parameters. Primary outcome measures and applied evaluations are shown in Table 1.   
Table 1. Primary outcome measures and evaluation methods 
 
Primary Outcome Measures  
Evaluation Methods 
Range of Motion (ROM) 
Goniometer  
Pain 
Visual Analogue Scale (VAS)  
Disability 
The Disabilities of the Arm, Shoulder and 
Hand (DASH) Questionnaire 
Quality of Shoulder Function 
Constant-Murley Score 
Muscle Strength 
Dynomometer  
                        Pain Threshold 
 
Algometer 
Proprioception 
 Marmara Visual Auditory Joint Education 
Device (MarvaJED) 
Kinesiophobia 
Tampa Kinesiophobia Scale (TKS) 
Satisfaction of the Treatment 
Visual Analogue Scale (VAS) 
  
The range of motion will be defined with ‘goniometer’, the pain with ‘Visual Analogue 
Scale (VAS)’, the disability with ‘The Disabilities of the Arm, Shoulder and Hand (DASH) 
Questionnaire’, the quality of shoulder function with ‘Constant- Murley Score’, the muscle 
strength with ‘dynomometer’, the pain threshold with algometer, the proprioception with 

 
  
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‘Marmara Visual Auditory Joint Education Device (MarvaJED)’, the kinesiophobia with 
‘Tampa Kinesiophobia Scale (TKS), the satisfaciton of the treatment with ‘Visual Analog Scale 
(VAS)’. 
  
 
Treatment Program  
The participants in the study will be rehabilitated in Cadde Medical Center for 5 times a 
week for 4 weeks, a total of 20 sessions (Duration of one session is 60 minutes).  
Group I (Control Group) will receive conventional physiotherapy and rehabilitation 
treatment program 
Group II (Study Group) will receive conventional physiotherapy and rehabilitation 
treatment program and game-based virtual reality exercises (with a device named USE-IT) (10 
minutes).  
  
Game-Based Virtual Reality Exercises 
In addition to the conventional physiotherapy and rehabilitation program, a 10-minute 
game-based virtual reality exercises will be applied. A game-based virtual reality device named 
USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation 
system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe 
University (Ankara, Turkey). It is a smart gaming device which has been used in patients who 
suffer from movement loss in their upper extremities due to various neurological and orthopedic 
reasons. 
 
Conventional Physiotherapy and Rehabilitation Program 
The conventional physiotherapy and rehabilitation program includes the application of 
Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, 
Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, 
strengthening exercises with elastic band and capsule stretching. 
  
  
  

 
  
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The Effectiveness of Game-Based Virtual Reality Approach in Patients with 
Subacromial Impingement Syndrome   
  
  
 
 
  
  
Statistical Analysis Plan (SAP)   
  
(Pages 6 – 7)   
  
  
  
  
  
  
 
 
April 8, 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. The initial 
demographic characteristics (age, boy, body weight) of all patients included in the study will be 
calculated.  
         ‘Shaphiro-Wilks Test’ will be used to investigate the appropriateness of the variables to 
normal distribution. ‘t-test’ will be used to compare the parameters of normal distribution in 
order to investigate the efficacy studies before and after the treatment; ‘Wilcoxon Test ‘ will be 
used to compare the parameters that do not comply with normal distribution. 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
  
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The Effectiveness of Game-Based Virtual Reality Approach in Patients with 
Subacromial Impingement Syndrome    
  
  
  
  
Annex  
  
(Pages 8 – 20)   
  
  
  
  
  
  
April 8, 2019  
 
 
 
 
 
 
 
 
  

 
  
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Annex 1. Marmara University Faculty of Health Sciences Ethical Committee 
Approval (Approval made at the meeting on 29.11.2018 with number: 36)  
 
  
 
 

 
  
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Annex 2. Participants Tracking Form 
Name-Surname:                                    
 
 
 
Date:  
Tel Number:                                                                                  Birth Date: 
Age:                      Sex:                        Height:                        Weight:   
Dominant Side (Mark):  Right / Left        
Effected Side (Mark):     Right/ Left  
How did the problem occur? (Please explain): 
 
 
 
Did you have any operation? Please write, if you did: 
 
 
Do you have any additional problem? 
No: 
Yes/ If yes, What is it? 
 
 
 
Assessment of Pain - Visual Analogue Scale 
 
- 
How severe is your shoulder pain during activity? 
 
      0………………………………5…………………………….10 
(no pain)                                                                              (worst possible pain) 
 
- 
How severe is your shoulder pain during rest? 
 
 0………………………………5…………………………….10 
(no pain)                                                                              (worst possible pain) 
 
 

 
  
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Assessment of Range of Motion and Muscle Strength 
 
  
 
Muscle Strength 
Range of Motion 
 
R 
L 
R 
L 
 
1 
2 
1 
2 
1 
2 
3 
1 
2 
3 
Shoulder  
Flexion 
 
 
 
 
 
 
 
 
 
 
Shoulder  
Extension 
 
 
 
 
 
 
 
 
 
 
Shoulder  
Abduction 
 
 
 
 
 
 
 
 
 
 
Shoulder  
Adduction 
 
 
 
 
 
 
 
 
 
 
Shoulder 
IR 
 
 
 
 
 
 
 
 
 
 
Shoulder 
ER 
 
 
 
 
 
 
 
 
 
 
Elbow 
Flexion 
 
 
 
 
 
 
 
 
 
 
Elbow 
Extension 
 
 
 
 
 
 
 
 
 
 
Supination  
 
 
 
 
 
 
 
 
 
Pronation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  
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Assesment of Disability - Disabilities of the Arm, Shoulder and Hand Questionnaire– 
DASH 
 
 

 
  
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Assessment of Quality of Shoulder Function- Constant Murley Score 
 
 

 
  
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Assessment of Kinesiophobia - Tampa Kinesiophobia Scale (TKS) 
 
 
 
 
 
  

 
  
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Assessment of satisfaction after the treatment 
 
 
- 
How satisfied are you with the decrease of pain at the end of treatment? 
 
      0………………………………5…………………………….10 
(Not satisfied at all)                                                       (Very satisfied)  
 
- 
How satisfied are you with your functionality at the end of treatment? 
 
      0………………………………5…………………………….10 
(Not satisfied at all)                                                       (Very satisfied) 
 
- 
How satisfied are you with all of your treatment? 
 
      0………………………………5…………………………….10 
(Not satisfied at all)                                                       (Very satisfied) 
 
 
- 
How satisfied are you with your physiotherapist? 
 
      0………………………………5…………………………….10 
(Not satisfied at all)                                                       (Very satisfied)