Effects of Balance Exercises Performed With Different Visual Stimuli

NCT ID: NCT06387043

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-01

Brief Summary

The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS.

Detailed Description

The study aims to examine the effects of balance exercises applied with virtual reality glasses, stroboscopic glasses, and visual-based metaphor imaginary on individuals with MS, on their balance functions, coordination skills, and quality of life, and to compare these exercises with both traditional balance exercises, and compare each of them on motor learning, based on their effects on representational areas in the brain, and balance.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Balance Games with Virtual Reality Glasses

Individuals with MS in the first group will play balance games with virtual reality glasses for 15 minutes. Three different progressive games will be determined according to the functional level of the individual. Each game offers different gradually increasing difficulty levels and time options.

Group Type: EXPERIMENTAL

Balance exercises with Virtual Reality Glasses

Intervention Type: OTHER

Balance exercises with Virtual Reality Glasses

Balance Exercises with Stroboscopic Glasses

Individuals with MS in the second group will be given balance exercises with stroboscopic glasses for 15 minutes. Exercises will be selected in accordance with the functional level of the individual and will progress according to the individual's condition. In each session, 3-5 different exercises will be performed, taking into account the functional status of the individual.

Group Type: EXPERIMENTAL

Balance Exercises with Stroboscopic Glasses

Intervention Type: OTHER

Balance Exercises with Stroboscopic Glasses

Balance Exercises with Visual-Based Metaphor Training

Individuals with MS in the third group will be given balance exercises simultaneously with metaphor training using various visuals for 15 minutes. The images will be projected on the screen in front of the individuals and the individuals will be given the command: "Imagine the movement you are doing as in the image." Meanwhile, reinforcers deemed necessary will be used by the researcher physiotherapist to increase the patient's participation and motivation. Static balance exercises in the program will be performed first on stable surfaces and then on unstable surfaces. In each session, 3-5 different exercises will be performed, taking into account the functional status of the individual. The difficulty levels of the exercises will progress by adjusting according to the functional status of the individual.

Group Type: EXPERIMENTAL

Balance Exercises with Visual-Based Metaphor Training

Intervention Type: OTHER

Balance Exercises with Visual-Based Metaphor Training

Traditional Balance Exercises

Individuals with MS in the fourth group will be given balance exercises for 15 minutes under the supervision of a researcher physiotherapist. Exercises will be selected in accordance with the functional level of the individual and will progress according to the individual's condition. In each session, 3-5 different exercises will be performed, taking into account the functional status of the individual.

Group Type: ACTIVE_COMPARATOR

Traditional Balance Exercises

Intervention Type: OTHER

Traditional Balance Exercises

Interventions

Balance exercises with Virtual Reality Glasses

Balance exercises with Virtual Reality Glasses

Intervention Type: OTHER

Balance Exercises with Stroboscopic Glasses

Balance Exercises with Stroboscopic Glasses

Intervention Type: OTHER

Balance Exercises with Visual-Based Metaphor Training

Balance Exercises with Visual-Based Metaphor Training

Intervention Type: OTHER

Traditional Balance Exercises

Traditional Balance Exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ages of 18-50
• diagnosis of MS by a neurologist according to McDonald 2017 criteria (Carroll, 2018)
• Being between 2.5 and 4.5 on the Expanded Disability Status Scale (EDSS)
• Not having had an attack in the last 3 months
• Absence of spasticity severe enough to affect treatment (spasticity in any joint of the upper extremity and lower extremity is <2 according to the Modified Ashworth Scale)
• Getting ≥ 24 points from the Standardized Mini Mental Test (SMMT)

Exclusion Criteria

• hearing or vision problems
• pregnancy
• Having changed medication in the last 3 months and using medication containing the active ingredient Fampridine
• Participating or participating in a regular physiotherapy and rehabilitation program in the last 3 months
• other accompanying neurological, orthopedic or vestibular disorders
• an upper or lower extremity contracture that prevents exercises
• History of epileptic seizure, migraine or vertigo attack in the last 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fenerbahce University

OTHER

Sponsor Role: collaborator

Biruni University

OTHER

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Halic University

OTHER

Sponsor Role: lead

Responsible Party

Gülsena Utku

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GÜLSENA UTKU UMUT

Role: PRINCIPAL_INVESTIGATOR

HALİÇ UNİVERSİTY

Locations

Haliç University

Istanbul, Eyüpsultan, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

GÜLSENA UTKU UMUT

Role: CONTACT

gulsenautkuumut@gmail.com

+905370664646

ARZU RAZAK ÖZDİNÇLER

Role: CONTACT

arzu.ozdincler@fbu.edu.tr

Other Identifiers

MS and Balance

Identifier Type: -

Identifier Source: org_study_id