Clinical trial NCT04283084: Development and Evaluation of Balance and Coordination Training System
Official title: Development of Enhanced Virtual Reality Based Balance and Coordination Training System and Evaluation of Its Effectiveness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Coordination and Balance Disturbances
Lower Extremity Problem
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Y Balance Test from baseline to week 6
timeFrame: 6 weeks
measure: Change in Single-Leg-Stance Test from baseline to week 6
timeFrame: 6 weeks
measure: Change in Lower Extremity Motor Coordination Test (LEMOCOT) from baseline to week 6
timeFrame: 6 weeks
measure: Change in Pedalo Sensamove Balance Test from baseline to week 6
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University Institute of Health Sciences
name: Dilara Merve Sari, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University Faculty of Health Sciences
name: Tugba Kuru Colak, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.