Clinical trial NCT06387043: Effects of Balance Exercises Performed With Different Visual Stimuli
Official title: Comparison of the Effects of Balance Exercises Performed With Different Visual Stimuli in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
visual stimulus
balance
virtual reality
stroboscopic glasses
metaphoric imaginary
Lead sponsor: Halic University
Sponsor class: OTHER
Collaborators: name: Fenerbahce University
name: Biruni University
name: Istanbul University - Cerrahpasa
First posted: 2024-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Near Infrared Ray Spectroscopy (fNIRS)
timeFrame: Baseline and end of the 8th week
measure: Timed Up and Go Test
timeFrame: Baseline and end of the 8th week
measure: Functional Reach Test
timeFrame: Baseline and end of the 8th week
measure: Berg Balance Scale
timeFrame: Baseline and end of the 8th week
measure: Timed 25 Step Walking Test
timeFrame: Baseline and end of the 8th week
Secondary outcomes:
measure: Lower Extremity Motor Coordination Test
timeFrame: Baseline and end of the 8th week
measure: Fatigue Severity Scale
timeFrame: Baseline and end of the 8th week
measure: Quality of Life in Multiple Sclerosis Patients
timeFrame: Baseline and end of the 8th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haliç University
state: Eyüpsultan
Study officials:
affiliation: HALİÇ UNİVERSİTY
name: GÜLSENA UTKU UMUT
role: PRINCIPAL_INVESTIGATOR
References: