Development and Evaluation of Balance and Coordination Training System

Study Overview
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Brief Summary
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This project aims to develop an interactive floor that will perceive the pressure, give the user visual (light) and auditory (signal) feedback, use a monitor that will guide the user with visual reporting, develop a software that enables the integration of the floor with the monitor, adjusts the degree of difficulty of education, records training, and objectively grades balance development, investigate the clinical effectiveness of the balance and coordination education system, in which hardware and software coexist, verify the validity and reliability of the developed system by evaluating its validity and reliability with proven tests.

Detailed Description
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In order to carry out daily life activities, independence of individuals should be insured. For this independence, it is necessary to have adequate balance and coordination. Without adequate balance and coordination, it is not possible to walk neither even to stand. Movement is the basic living unit of an organism. Balance and coordination are of great importance for smooth, fluid and convenient action. In the clinical settings individuals are given exercises in different ways to increase their balance and coordination to protect them from injuries and to gain their independence. Nowadays, in order to adapt to the future, technological devices that can analyze and improve balance and coordination are being developed. The adequacy of the devices or systems developed for this purpose is also discussed. Most of the systems available on market only provide balance training by moving the floor, while others aim to contribute to balance by stimulating joint proprioception with a vibrating ground. This project aims to develop equipments that will provide balance and coordination trainings to guide the user through visual, auditory and mechanical feedback, develop a software which will record, analyze and evaluate the trainings given while ensuring that this equipment works systematically, carry out clinical studies to investigate the effectiveness of this developed system in healthy people.

Official Title
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Development of Enhanced Virtual Reality Based Balance and Coordination Training System and Evaluation of Its Effectiveness

Conditions
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Healthy, Coordination and Balance Disturbances, Lower Extremity Problem

Intervention / Treatment
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* Device: Virtual Reality Based Balance and Coordination Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate Being healthy Being between 18-45 years of age Exclusion Criteria: Presence of any neurological or orthopedic problems that may affect balance and coordination, Being pregnant, Any drug use that may affect balance and coordination, Any deformation in vertebrae or lower limbs, History of any surgery in the lower limbs in the preceding 1 year, Any nervous lesion, existing neurological diseases, sensory defects, Any hearing or visual problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Number of participants in this group is anticipated to be 25. Participants in this group will be receiving 10 minutes of exercise with the virtual reality based balance and coordination training system (MARBES). In the MARBES system two exercises (1. Balance exercise, 2. Coordination exercise) will be played for 5 minutes each. | Device: Virtual Reality Based Balance and Coordination Exercises<br>* With the developed virtual reality based balance and coordination training system, balance and coordination exercises will be applied twice a week (12 sessions in total) for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Y Balance Test from baseline to week 6 | The Y Balance Test (YBT) is a simple, yet reliable, test used to measure dynamic balance (1). It was developed to standardize the modified Star Excursion Balance Test (mSEBT), improve its practicality, and make it commercially available. The YBT requires the athlete to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial. Therefore, this test measures the athlete's strength, stability and balance in various directions. The YBT composite score is calculated by summing the 3 reach directions and normalizing the results to the lower limb length. | 6 weeks | 
| Change in Single-Leg-Stance Test from baseline to week 6 | The Single-Leg-Stance Test (SLST) is a static balance test that has been used widely in older adults and has normative data accepted by the scientific literature. To perform the test, the patient is instructed to stand on one leg without support of the upper extremities or bracing of the unweighted leg against the stance leg. The patient begins the test with the eyes open, practicing once or twice on each side. The patient is then instructed to close his eyes and maintain balance for up to 45 seconds. The number of seconds that the patient/client is able to maintain this position is recorded. Termination or a fail test is recorded if 1) the foot touches the support leg; 2) hopping occurs; 3) the foot touches the floor, or 4) the arms touch something for support. | 6 weeks | 
| Change in Lower Extremity Motor Coordination Test (LEMOCOT) from baseline to week 6 | The LEMOCOT consists of moving the lower extremity as fast as possible from 1 target to another for 20 seconds. The number of on-target touches constitutes the score. | 6 weeks | 
| Change in Pedalo Sensamove Balance Test from baseline to week 6 | Pedalo®-Sensomove balance device consists of a mini board which is a circular board with hemispheric shaped sensors placed below it and works as three-dimensional accelerometer and gyroscope with a sample frequency of 100 Hz. | 6 weeks |