Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development and Evaluation of Balance and Coordination Training System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283084
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Marmara University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Coordination and Balance Disturbances Lower Extremity Problem Device: Virtual Reality Based Balance and Coordination Exercises Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283084


Contacts
Layout table for location contacts
Contact: Dilara Merve Sari, MSc +905333444601 dilaramervesari@gmail.com

Sponsors and Collaborators
Marmara University
Investigators
Layout table for investigator information
Principal Investigator: Dilara Merve Sari, MSc Marmara University Institute of Health Sciences
Study Director: Tugba Kuru Colak, PhD Marmara University Faculty of Health Sciences
Publications:
Layout table for additonal information
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT04283084    
Other Study ID Numbers: 09.2017.257
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No