Effects of Balance Exercises Performed With Different Visual Stimuli

NCT06387043 | Not Yet Recruiting

• 1 other identifier: MS and Balance
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; visual stimulus; balance; virtual reality; stroboscopic glasses; metaphoric imaginary

Outcome Measures

Primary Outcomes (5)

• Functional Near Infrared Ray Spectroscopy (fNIRS)

  Functional near-infrared spectroscopy is a device used to evaluate brain functions in the cerebral cortex. This device is an optical brain imaging method that measures the blood oxygenation level-dependent (BOLD) response of brain tissues. With this method, relative changes in regional brain oxygenation in the part thought to be associated with brain activation can be determined. In our study, Artinis Brite Lite® fNIRS systems will be used. The system consists of a wearable soft head and has 10 channels. In the evaluation procedure, a trial session will be conducted before the actual measurement, during which the subjects will be fitted with an fNIRS headset. The balance tasks to be evaluated will consist of right and left weight transfer, standing with two feet together, standing on one leg, tandem walking, turning from right to left/left to right, jumping in place and jumping over obstacles (Sathe et al., 2023).

  Baseline and end of the 8th week

• Timed Up and Go Test

  It is an assessment tool with strong evidence for its validity as a measure of functional mobility in individuals with MS ( Sebastiao et al., 2016 ).

  Baseline and end of the 8th week

• Functional Reach Test

  It is an easily applicable dynamic balance measurement technique that has features similar to functional movements. Distances below 15 cm have been found to be associated with an increased risk of falling (Weiner et al., 1992).

  Baseline and end of the 8th week

• Berg Balance Scale

  Berg Balance Scale is a scale that is widely used to evaluate balance disorders in multiple sclerosis patients (Berg et al., 1989), provides information about the patient's balance function, and is used to evaluate post-rehabilitation improvements (Gervasoni et al., 2016). The scale consists of 14 items for monitoring performance. Each item is scored between 0 and 4; A high score indicates good balance.

  Baseline and end of the 8th week

• Timed 25 Step Walking Test

  It will be used to evaluate the walking speed of individuals. In Z25YT, which evaluates lower extremity function, patients are asked to walk a distance of 7.62 m as quickly as possible, but without running and safely, and the completion time is recorded in seconds.

  Baseline and end of the 8th week

Secondary Outcomes (3)

• Lower Extremity Motor Coordination Test

  Baseline and end of the 8th week

• Fatigue Severity Scale

  Baseline and end of the 8th week

• Quality of Life in Multiple Sclerosis Patients

  Baseline and end of the 8th week

Study Arms (4)

Balance Games with Virtual Reality Glasses

EXPERIMENTAL

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.

Other: Balance exercises with Virtual Reality Glasses

Balance Exercises with Stroboscopic Glasses

EXPERIMENTAL

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.

Other: Balance Exercises with Stroboscopic Glasses

Balance Exercises with Visual-Based Metaphor Training

EXPERIMENTAL

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.

Other: Balance Exercises with Visual-Based Metaphor Training

Traditional Balance Exercises

ACTIVE COMPARATOR

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.

Other: Traditional Balance Exercises

Interventions

Balance exercises with Virtual Reality Glasses OTHER

Balance exercises with Virtual Reality Glasses

Balance Games with Virtual Reality Glasses

Balance Exercises with Stroboscopic Glasses OTHER

Balance Exercises with Stroboscopic Glasses

Balance Exercises with Stroboscopic Glasses

Balance Exercises with Visual-Based Metaphor Training OTHER

Balance Exercises with Visual-Based Metaphor Training

Balance Exercises with Visual-Based Metaphor Training

Traditional Balance Exercises OTHER

Traditional Balance Exercises

Traditional Balance Exercises

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Halic University: lead
• Fenerbahce University: collaborator
• Biruni University: collaborator
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Haliç University

Istanbul, Eyüpsultan, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GÜLSENA UTKU UMUT

  HALİÇ UNİVERSİTY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GÜLSENA UTKU UMUT

CONTACT

+905370664646; gulsenautkuumut@gmail.com

ARZU RAZAK ÖZDİNÇLER

CONTACT

arzu.ozdincler@fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 26, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

TU (1)