Development and Evaluation of Balance and Coordination Training System
|ClinicalTrials.gov Identifier: NCT04283084|
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : March 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Coordination and Balance Disturbances Lower Extremity Problem||Device: Virtual Reality Based Balance and Coordination Exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of Enhanced Virtual Reality Based Balance and Coordination Training System and Evaluation of Its Effectiveness|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||August 20, 2020|
|Estimated Study Completion Date :||September 20, 2020|
Experimental: Study group
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
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.
- Change in Y Balance Test from baseline to week 6 [ Time Frame: 6 weeks ]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.
- Change in Single-Leg-Stance Test from baseline to week 6 [ Time Frame: 6 weeks ]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.
- Change in Lower Extremity Motor Coordination Test (LEMOCOT) from baseline to week 6 [ Time Frame: 6 weeks ]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.
- Change in Pedalo Sensamove Balance Test from baseline to week 6 [ Time Frame: 6 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283084
|Contact: Dilara Merve Sari, MScemail@example.com|
|Principal Investigator:||Dilara Merve Sari, MSc||Marmara University Institute of Health Sciences|
|Study Director:||Tugba Kuru Colak, PhD||Marmara University Faculty of Health Sciences|