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Clinical Trials/NCT06387043
NCT06387043
Not Yet Recruiting
N/A

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

Halic University1 site in 1 country40 target enrollmentDecember 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Halic University
Enrollment
40
Locations
1
Primary Endpoint
Timed Up and Go Test
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
December 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gülsena Utku

Research Assistant

Halic University

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

Outcomes

Primary Outcomes

Timed Up and Go Test

Time Frame: Baseline and end of the 8th week

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 ).

Functional Reach Test

Time Frame: Baseline and end of the 8th week

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).

Berg Balance Scale

Time Frame: Baseline and end of the 8th week

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.

Functional Near Infrared Ray Spectroscopy (fNIRS)

Time Frame: Baseline and end of the 8th week

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).

Timed 25 Step Walking Test

Time Frame: Baseline and end of the 8th week

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.

Secondary Outcomes

  • Quality of Life in Multiple Sclerosis Patients(Baseline and end of the 8th week)
  • Fatigue Severity Scale(Baseline and end of the 8th week)
  • Lower Extremity Motor Coordination Test(Baseline and end of the 8th week)

Study Sites (1)

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