Multiple SclerosisNCT06387043
Effects of Balance Exercises Performed With Different Visual Stimuli
A study testing Balance exercises with Virtual Reality Glasses, Balance Exercises with Stroboscopic Glasses and Balance Exercises with Visual-Based Metaphor Training in people with Multiple Sclerosis, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Balance exercises with Virtual Reality Glasses, Balance Exercises with Stroboscopic Glasses and Balance Exercises with Visual-Based Metaphor Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ARZU RAZAK ÖZDİNÇLER contact
About this study
Official title: Comparison of the Effects of Balance Exercises Performed With Different Visual Stimuli in Individuals With Multiple Sclerosis
The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS.
Read the 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
- Being tested
- Balance exercises with Virtual Reality Glasses, Balance Exercises with Stroboscopic Glasses, Balance Exercises with Visual-Based Metaphor Training, Traditional Balance Exercises
- Keywords
- multiple sclerosis, visual stimulus, balance, virtual reality, stroboscopic glasses, metaphoric imaginary
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exercises with Virtual Reality GlassesOther
Balance exercises with Virtual Reality Glasses
Balance Exercises with Stroboscopic GlassesOther
Balance Exercises with Stroboscopic Glasses
Balance Exercises with Visual-Based Metaphor TrainingOther
Balance Exercises with Visual-Based Metaphor Training
Traditional Balance ExercisesOther
Traditional Balance Exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Traditional Balance Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 ).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and end of the 8th week
Secondary outcomes (3)
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).
Measured: Baseline and end of the 8th week
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).
Measured: Baseline and end of the 8th week
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 İdiman 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 (İdiman et al., 2006).
Measured: Baseline and end of the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsena Utku, Halic University
- Investigators
- GÜLSENA UTKU UMUT, Principal investigator, HALİÇ UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387043
- Sponsor's protocol ID
- MS and Balance
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Balance Exercises Performed With Different Visual Stimuli in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06387043
- Acronym / sponsor ID
- MS and Balance
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, visual stimulus, balance, virtual reality, stroboscopic glasses, metaphoric imaginary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Fenerbahce University, Biruni University, Istanbul University - Cerrahpasa
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Balance Games with Virtual Reality Glasses | Experimental | Other: Balance exercises with Virtual Reality GlassesIndividuals 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. |
| Balance Exercises with Stroboscopic Glasses | Experimental | Other: Balance Exercises with Stroboscopic GlassesIndividuals 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. |
| Balance Exercises with Visual-Based Metaphor Training | Experimental | Other: Balance Exercises with Visual-Based Metaphor TrainingIndividuals 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. |
| Traditional Balance Exercises | Active comparator | Other: Traditional Balance ExercisesIndividuals 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance exercises with Virtual Reality GlassesBalance exercises with Virtual Reality Glasses | Other | Balance Games with Virtual Reality Glasses |
| Balance Exercises with Stroboscopic GlassesBalance Exercises with Stroboscopic Glasses | Other | Balance Exercises with Stroboscopic Glasses |
| Balance Exercises with Visual-Based Metaphor TrainingBalance Exercises with Visual-Based Metaphor Training | Other | Balance Exercises with Visual-Based Metaphor Training |
| Traditional Balance ExercisesTraditional Balance Exercises | Other | Traditional Balance Exercises |
Primary outcome
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 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.
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.
3 secondary outcomes
Lower Extremity Motor Coordination Test
Time frame: Baseline and end of the 8th week
Fatigue Severity Scale
Time frame: Baseline and end of the 8th week
Quality of Life in Multiple Sclerosis Patients
Time frame: Baseline and end of the 8th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ARZU RAZAK ÖZDİNÇLER contact
GÜLSENA UTKU UMUT principal investigator
HALİÇ UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance exercises with Virtual Reality Glasses, Balance Exercises with Stroboscopic Glasses and Balance Exercises with Visual-Based Metaphor Training in people with Multiple Sclerosis, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GÜLSENA UTKU UMUT (+905370664646, gulsenautkuumut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Near Infrared Ray Spectroscopy (fNIRS) (time frame: Baseline and end of the 8th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.