Development and Evaluation of Balance and Coordination Training System

NCT ID: NCT04283084

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-06-20

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.

Conditions

Healthy; Coordination and Balance Disturbances; Lower Extremity Problem

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Based Balance and Coordination Exercises

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dilara Merve Sari, MSc

Role: PRINCIPAL_INVESTIGATOR

Marmara University Institute of Health Sciences

Tugba Kuru Colak, PhD

Role: STUDY_DIRECTOR

Marmara University Faculty of Health Sciences

Central Contacts

Dilara Merve Sari, MSc

Role: CONTACT

dilaramervesari@gmail.com

+905333444601

References

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.

Reference Type: BACKGROUND

PMID: 2742465 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15895347 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12127181 (View on PubMed)

Other Identifiers

09.2017.257

Identifier Type: -

Identifier Source: org_study_id