Effects of Balance Exercises Performed With Different Visual Stimuli

Multiple Sclerosis Clinical Trial

Official title:

Comparison of the Effects of Balance Exercises Performed With Different Visual Stimuli in Individuals With Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387043
• Other study ID #: MS and Balance
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: Halic University
• Contact: GÜLSENA UTKU UMUT
• Phone: +905370664646
• Email: gulsenautkuumut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Balance exercises with Virtual Reality Glasses
Balance exercises with Virtual Reality Glasses
• Balance Exercises with Stroboscopic Glasses
Balance Exercises with Stroboscopic Glasses
• Balance Exercises with Visual-Based Metaphor Training
Balance Exercises with Visual-Based Metaphor Training
• Traditional Balance Exercises
Traditional Balance Exercises

Locations

Country	Name	City	State
Turkey	Haliç University	Istanbul	Eyüpsultan

Sponsors (4)

Lead Sponsor	Collaborator
Halic University	Biruni University, Fenerbahce University, Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Lower Extremity Motor Coordination Test	This test was developed by Desrosiers et al. to evaluate the lower extremity motor coordination skills of patients with a history of stroke, low back pain and surgery. Developed by. The test begins with the individual sitting on a chair with the knees and ankles at a 90-degree angle. Two red targets with a diameter of 6 cm are placed in front of it, distally and proximally, on a 55x50x0.4 cm mat, with 19 specific localization dimensions. The individual is asked to touch the target closest to the big toe as quickly and smoothly as possible. The number of movements made repetitively, smoothly and as fast as possible within 20 seconds is recorded (Desrosiers et al., 2005).	Baseline and end of the 8th week
Secondary	Fatigue Severity Scale	It is a scale consisting of 9 questions that evaluates fatigue. Each item is scored between 0 and 7. The total score is calculated by taking the arithmetic average of the scores. A score <4 is interpreted as no fatigue, and a score =4 as fatigue (Whitehead, 2009). The Turkish validity and reliability study of the scale was conducted by Armutlu et al., (Armutlu et al., 2007).	Baseline and end of the 8th week
Secondary	Quality of Life in Multiple Sclerosis Patients	Multiple Sclerosis Quality of Life Scale-54 was developed in 1995 by Vickrey et al. It was developed by (Vickrey et al., 1995); Turkish validity and reliability study by Idiman et al. Made by. The scale examines individuals' health-related quality of life levels with Likert-type scoring in a total of 54 questions prepared specifically for MS disease. Scoring varies between 0-100, with a higher score indicating a better quality of life (Idiman et al., 2006).	Baseline and end of the 8th week