Development and Evaluation of Balance and Coordination Training System

NCT04283084 | Unknown

• 1 other identifier: 09.2017.257
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy; Coordination and Balance Disturbances; Lower Extremity Problem

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

Virtual Reality Based Balance and Coordination Exercises DEVICE

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.

Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer to participate
• Being healthy
• Being between 18-45 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Related Publications (3)

• Goldie PA, Bach TM, Evans OM. Force platform measures for evaluating postural control: reliability and validity. Arch Phys Med Rehabil. 1989 Jul;70(7):510-7.

  PMID: 2742465 BACKGROUND

• Desrosiers J, Rochette A, Corriveau H. Validation of a new lower-extremity motor coordination test. Arch Phys Med Rehabil. 2005 May;86(5):993-8. doi: 10.1016/j.apmr.2004.11.007.

  PMID: 15895347 BACKGROUND

• Woollacott M, Shumway-Cook A. Attention and the control of posture and gait: a review of an emerging area of research. Gait Posture. 2002 Aug;16(1):1-14. doi: 10.1016/s0966-6362(01)00156-4.

  PMID: 12127181 BACKGROUND

Study Officials

• Dilara Merve Sari, MSc

  Marmara University Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Tugba Kuru Colak, PhD

  Marmara University Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Dilara Merve Sari, MSc

CONTACT

+905333444601; dilaramervesari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: October 1, 2020
• Primary Completion: May 20, 2021
• Study Completion: June 20, 2021
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share