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Multiple SclerosisNCT06874764

Effect of Training With Wireless Lightning Reaction Systems on Cognitive Functions in Individuals With Multiple Sclerosis

A study testing Wireless Lighting Reaction System Training(Agility plus Cognitive) in people with Multiple Sclerosis, run by Ege University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

When the literature is examined, balance disorders, walking disorders and cognitive problems are frequently observed in Multiple Sclerosis(MS) patients. Using technologically supported equipment such as reaction systems, cognitive function measurements have been successfully performed in the elderly, and improvements… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Wireless Lighting Reaction System Training(Agility plus Cognitive)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jan 2026to Aug 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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Being between the ages of 18-55
  • Having a definite MS diagnosis according to the 2017 McDonald criteria.
  • EDSS score of 4 or below
  • Being able to communicate (speaking and understanding Turkish, no speech disorders)

Who cannot join

  • Regular exercise in the last 6 months
  • Having an MS attack in the last month
  • Having an MS attack during the study period
  • Presence of additional accompanying neurological diseases
  • Use of dalfampridine
  • Use of antipsychotic and psychostimulant drugs
Show all 10Show fewer
  • Drug and alcohol addiction
  • Pregnancy, breastfeeding
  • No chronic systemic disease preventing exercise
  • Patients who cannot reach the targeted exercise level

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Ege University Sport Medicine Clinic

    Izmir, Bornova

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Agility and Cognitive Training With Reaction System on Cognitive Functions and Walking in Individuals With Multiple Sclerosis

When the literature is examined, balance disorders, walking disorders and cognitive problems are frequently observed in Multiple Sclerosis(MS) patients. Using technologically supported equipment such as reaction systems, cognitive function measurements have been successfully performed in the elderly, and improvements in reaction times have been detected in athletes when used for training purposes. The primary aim of the study is to provide improvement in agility and cognitive functions in patients using a technology-supported reaction device. In addition, it aims to improve balance function assessed with static posturography and gait parameters assessed with gait analysis by increasing sensory input and shortening reaction time. As a result of the agility and cognitive training performed, we aim to provide improvement in MS-related quality of life and decrease in disability.

Read the detailed description

Multiple Sclerosis (MS) is an immune-mediated central nervous system disease characterized by inflammation, demyelination, and axonal damage. Myelin sheaths, oligodendrocytes, and to a lesser extent the axon and the nerve cell itself are damaged.Balance problems can be seen even in the early stages of MS. In the later stages of the disease, they are the primary cause of falls. Balance is defined as the body's ability to maintain its center of gravity with minimal sway. Approximately two-thirds of MS patients report balance or coordination problems that affect their daily lives.Gait impairment is common in MS patients. Walking speed, quality and endurance are the components of the Expanded Disability Status Scale (EDSS), which is most commonly used to monitor MS-related disability and disease progression.Inflammation and demyelination that develop during the MS process have significant effects on central nervous system functions, especially cognitive performance. Approximately 40-70% of people with multiple sclerosis have cognitive impairments such as slowed processing speed, impaired learning and memory functions, and deficits in executive functions. These symptoms affect patients' emotional well-being, work capacity, and quality of life (QoL).Reaction systems (Witty SEM, Microgate, Bolzano, Italia) are devices with computer-aided wireless lighting feature that evaluate and train various visual, cognitive and sensory-motor skills. It consists of an light emitting diode(LED) screen that displays different colors, numbers and characters. This technology is used for evaluation and special training for reactivity, agility and coordination.A total of 40 male and female individuals between the ages of 18-55 will be included in the study. Participants will be divided into two different groups as intervention and control in equal numbers. In both groups, the Brief International Cognitive Assessment for MS (BICAMS) battery, Berg Balance Scale, Hospital Anxiety and Depression Scale (HADS), Fatigue Severity Scale (FSS) and Short Form-36 (SF-36) health questionnaire will be applied to the participants before the study. BICAMS is a battery consisting of the California Verbal Learning Test II (CVLT II), Symbol Digit Modalities Test (SDMT) and Brief Visuospatial Memory Test-Revised (BVMTR) subscales used in the assessment of cognitive status in MS patients.In both groups, before the study, static posturography (HUR SMART BALANCE BTG4) will be used and the patients' balance-related measurements such as forward-backward and sideways swings, swing speeds during pressure, and measurements of the static balance scores provided by the device will be noted, respectively, in the eyes open normal ground - eyes closed normal ground - eyes open soft mat - eyes closed soft mat ground.In addition, using the pressure-gait analysis system (DIERS International GmbH, Schlangenbad, Germany), the participants will undergo pressure analysis and walking evaluation on a treadmill at a walking speed chosen by the patient between 2-5 km/h for approximately 20 seconds.The intervention group will be trained at a difficulty level appropriate to their individual levels to improve agility and cognitive functions using the reaction system 2 days a week for 2 months, and if the participant can easily perform the relevant training, the difficulty will be increased by one level. Each training session will last approximately 30 minutes. There will be no intervention in the control group. At the end of the 8 weeks, the scales, questionnaires and measurements made before the study will be repeated in both groups.

Being tested
Wireless Lighting Reaction System Training(Agility plus Cognitive)
Keywords
Multiple sclerosis, Cognitive, Virtual reality, Agility, Training, Gait
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wireless Lighting Reaction System Training(Agility plus Cognitive)Other

    Agility training and Cognitive trainings(cognitive trainings ready within the device: Eye for detail, Hawk eye, Juggle Factor)

Study groups in NCT06874764
Study groupRoleWhat they receive
Training GroupExperimentalThe intervention group will be trained with a difficulty appropriate to their individual levels for 2 months using the reaction system 2 days a week to improve agility and cognitive functions, and if the participant can easily perform the relevant training, the difficulty will be increased by one level. Agility training aims to reach the light side sensor with the hand in order and to do this within the specified time, and aims to speed up the participant's reaction time in the foreground. Cognitive training consists of different trainings such as finding the different image illuminated in 8 sensors, finding two identical signs, remembering the order in which the sensors light up, and touching the sensors in that order. These trainings aim to increase the participant's quick thinking and decision making, and to improve attention, visual memory, visual processing speed, and cognitive functions. Each training session will last approximately 30 minutes.
Receives: Other: Wireless Lighting Reaction System Training(Agility plus Cognitive)
Control GroupNo interventionThe control group will not receive any intervention. They will be asked to continue their normal lives.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Functions

    the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) is a battery with demonstrated validity and reliability in Turkish, consisting of the California Verbal Learning Test II (CVLT II), Symbol Digit Modalities Test (SDMT) and Brief Visuospatial Memory Test-Revised (BVMTR) subscales, used to assess cognitive status in MS patients SDMT: There is no lower or upper limit for scoring. A higher number of correct answers (higher scores) is associated with better results.

    CVLTII:The upper limit for scoring is 80. A higher number of correct answers (higher scores) is associated with better results.

    BVMTR:The score range is 0-12. Higher scores are associated with better outcomes.

    Measured: 8th week

Secondary outcomes (14)
  1. Balance assessment

    Berg Balance Scale: It is a scale consisting of 14 tests that measure the ability to maintain balance during different positions, postural changes and movement. The evaluation is based on the person's ability to perform each test independently and/or for a certain time or distance. The rating is made between 0 and 4 points (0: cannot do, 4: normal performance). The total score varies between 0 (dependent) and 56 (independent). High scores are associated with independent movement and low risk of falling. The validity and reliability of this scale has been shown in Turkish.

    Measured: 8th week

  2. Anxiety and Depression Status

    HADS (Hospital Anxiety and Depression Scale): The scale is a self-report scale. It consists of 14 items, 7 of which investigate depression and 7 of which investigate anxiety symptoms. Responses are evaluated in a four-point Likert format and are scored between 0-3. It is often used for screening purposes. The scale can also be used to evaluate the change in the patient's emotional state. The score range for both subscales are 0-21 High scores indicate an increase in depression and/or anxiety.

    Measured: 8th week

  3. Fatigue Assessment

    FSS (Fatigue Severity Scale): A nine-item scale designed to assess fatigue as a symptom of various chronic conditions and disorders. The scale addresses the effects of fatigue on daily functioning, questions its relationship to motivation, physical activity, work, family and social life, and asks participants to rate how easily they tire and the extent to which this causes problems for them. Participants respond to nine statements about fatigue on a scale ranging from 1 ("completely disagree") to 7 ("completely agree"). The score range for the test is 9-63. Higher scores on the scale indicate more severe fatigue.FSS measures the severity of fatigue and is widely used in multiple sclerosis patients. The validity and reliability of this scale in Turkish has been demonstrated.

    Measured: 8th week

  4. MS Quality of Life

    SF-36 (Short Form 36): The SF-36 is a set of general, consistent, and easily administered quality of life measures. These measures are based on patient self-report. The SF-36 has eight subscales; scores are weighted sums of questions in each section, ranging from 0 to 100. Higher scores are associated with better quality of life. Validity and reliability have been demonstrated in Turkish

    Measured: 8th week

  5. Static Posture Assessment(Static Balance)

    Static Posturography: Static posturography is based on the principle of measuring changes in the center of pressure on a stationary platform. In a calm posture, the body is normally held upright and the center of mass is elevated above the base of support provided by the feet. Although it is generally assumed that the center of pressure (COP) indicates the location of the body's center of mass, discrepancies between the two occur, especially during rapid or high-frequency components of movement.

    Static Balance Score: indicates the individual's ability to stand still with eyes open on a firm surface. It will be calculated automatically by the device and used as a reference for other measurements. Scoring ranges from 0 to 100. Higher scores are associated with better outcomes.

    Measured: 8th week

  6. Static Posture Assessment(Visual Dependency)

    Static Posturography: Static posturography is based on the principle of measuring changes in the center of pressure on a stationary platform. In a calm posture, the body is normally held upright and the center of mass is elevated above the base of support provided by the feet. Although it is generally assumed that the center of pressure (COP) indicates the location of the body's center of mass, discrepancies between the two occur, especially during rapid or high-frequency components of movement.

    Visual Dependency Score: Visual Dependency Score indicates how closing the eyes can affect an individual's ability to stand still on a firm surface.With eyes closed, the effects of vision on balance are assessed.The score will be calculated automatically by the device. Scoring ranges from 0 to 100. Higher scores are associated with better outcomes.

    Measured: 8th week

  7. Static Posture Assessment(Proprioception Disturbance)

    Static Posturography: Static posturography is based on the principle of measuring changes in the center of pressure on a stationary platform. In a calm posture, the body is normally held upright and the center of mass is elevated above the base of support provided by the feet. Although it is generally assumed that the center of pressure (COP) indicates the location of the body's center of mass, discrepancies between the two occur, especially during rapid or high-frequency components of movement.

    Proprioception Disturbance Score:indicates how much standing on a soft foam surface can affect the individual's ability to stand still with eyes open.With eyes open and on soft ground, rubber pads restrict the somatosensory system.The score will be calculated automatically by the device. Scoring ranges from 0 to 100. Higher scores are associated with better outcomes.

    Measured: 8th week

  8. Static Posture Assessment(Vestibular Dominant)

    Static Posturography: Static posturography is based on the principle of measuring changes in the center of pressure on a stationary platform. In a calm posture, the body is normally held upright and the center of mass is elevated above the base of support provided by the feet. Although it is generally assumed that the center of pressure (COP) indicates the location of the body's center of mass, discrepancies between the two occur, especially during rapid or high-frequency components of movement.

    Vestibular Dominant Score:indicates how much closing eyes and standing on a soft surface can affect the individual's ability to stand still and balanced.With eyes closed and on the mat, only the vestibular system is worked on and evaluated.The score will be calculated automatically by the device. Scoring ranges from 0 to 100. Higher scores are associated with better outcomes.

    Measured: 8th week

  9. Gait Analysis(Step length)

    The participants gait analysis will be performed using Diers pedogait. The participant will be asked to stand still on the treadmill at the beginning then walk of approximately 20 seconds at a speed chosen by the patient between 2-5 km/h. Diers pedoscan have been shown to be effective in detecting early-stage gait disorders in MS patients. Data to be evaluated after this measurement:

    Step length:During a gait cycle, the time from initial contact of one foot to initial contact of the opposite foot.Studies show a decrease in step length in people with MS compared to healthy controls. Pre- and post-intervention values will be compared

    Measured: 8th week

  10. Gait Analysis(Stride length)

    The participants gait analysis will be performed using Diers pedogait. The participant will be asked to stand still on the treadmill at the beginning then walk of approximately 20 seconds at a speed chosen by the patient between 2-5 km/h. Diers pedoscan have been shown to be effective in detecting early-stage gait disorders in MS patients. Data to be evaluated after this measurement:

    Stride length:the distance covered between the spot where one foot hits the ground and the next time that same foot hits the ground again.Studies show a decrease in stride length in people with MS compared to healthy controls. Pre- and post-intervention values will be compared

    Measured: 8th week

  11. Gait Analysis(Step time)

    The participants gait analysis will be performed using Diers pedogait. The participant will be asked to stand still on the treadmill at the beginning then walk of approximately 20 seconds at a speed chosen by the patient between 2-5 km/h. Diers pedoscan have been shown to be effective in detecting early-stage gait disorders in MS patients. Data to be evaluated after this measurement:

    Step time:the time from initial contact of one foot to initial contact of the opposite foot.The MS population displayed significantly longer step time in comparison to the healthy population.Pre- and post-intervention values will be compared

    Measured: 8th week

  12. Gait Analysis(Step width)

    The participants gait analysis will be performed using Diers pedogait. The participant will be asked to stand still on the treadmill at the beginning then walk of approximately 20 seconds at a speed chosen by the patient between 2-5 km/h. Diers pedoscan have been shown to be effective in detecting early-stage gait disorders in MS patients. Data to be evaluated after this measurement:

    Step width:Stride width is measured either between the medial-most borders of the two heels or between lines through the midline of the two heels. Normal stride width for adults is between 1-3 inches (3-8 cm). Stride width often increases with gait instability.The people with MS demonstrated a significantly increased step width when compared to healthy controls when walking at a self-selected pace in the literature.Pre- and post-intervention values will be compared

    Measured: 8th week

  13. Gait Analysis(Cadence)

    The participants gait analysis will be performed using Diers pedogait. The participant will be asked to stand still on the treadmill at the beginning then walk of approximately 20 seconds at a speed chosen by the patient between 2-5 km/h. Diers pedoscan have been shown to be effective in detecting early-stage gait disorders in MS patients. Data to be evaluated after this measurement:

    Cadence:is the number of steps taken per minute. People with the MS having a significantly reduced cadence in comparison to the healthy control population in the literature.Pre- and post-intervention values will be compared

    Measured: 8th week

  14. Gait Analysis(Percentage distribution of walking phases)

    The participants gait analysis will be performed using Diers pedogait. The participant will be asked to stand still on the treadmill at the beginning then walk of approximately 20 seconds at a speed chosen by the patient between 2-5 km/h. Diers pedoscan have been shown to be effective in detecting early-stage gait disorders in MS patients. Data to be evaluated after this measurement:

    Stance, Swing and Double support phase: The percentage ratios of the specified phases in a gait cycle will be calculated.In the literature, the MS population has significantly increased double support time when compared to the healthy control group. A significant increase in time spent in the swing phase was noted in the healthy population when compared to MS.Pre- and post-intervention values will be compared

    Measured: 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06874764
Sponsor's protocol ID
25-5/4
Status last verified
Jan 2026
First submitted
3 Mar 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Matsuda PN, Shumway-Cook A, Ciol MA, Bombardier CH, Kartin DA. Understanding falls in multiple sclerosis: association of mobility status, concerns about falling, and accumulated impairments. Phys Ther. 2012 Mar;92(3):407-15. doi: 10.2522/ptj.20100380. Epub 2011 Dec 1.

    PubMed 22135709
  • Martin CL, Phillips BA, Kilpatrick TJ, Butzkueven H, Tubridy N, McDonald E, Galea MP. Gait and balance impairment in early multiple sclerosis in the absence of clinical disability. Mult Scler. 2006 Oct;12(5):620-8. doi: 10.1177/1352458506070658.

    PubMed 17086909
  • Pollock AS, Durward BR, Rowe PJ, Paul JP. What is balance? Clin Rehabil. 2000 Aug;14(4):402-6. doi: 10.1191/0269215500cr342oa.

    PubMed 10945424
  • Prosperini L, Castelli L. Spotlight on postural control in patients with multiple sclerosis. Degener Neurol Neuromuscul Dis. 2018 Apr 3;8:25-34. doi: 10.2147/DNND.S135755. eCollection 2018.

    PubMed 30050386
  • Iqbal K. Mechanisms and models of postural stability and control. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7837-40. doi: 10.1109/IEMBS.2011.6091931.

    PubMed 22256156
  • Creath R, Kiemel T, Horak F, Jeka JJ. The role of vestibular and somatosensory systems in intersegmental control of upright stance. J Vestib Res. 2008;18(1):39-49.

    PubMed 18776597
  • Melillo F, Di Sapio A, Martire S, Malentacchi M, Matta M, Bertolotto A. Computerized posturography is more sensitive than clinical Romberg Test in detecting postural control impairment in minimally impaired Multiple Sclerosis patients. Mult Scler Relat Disord. 2017 May;14:51-55. doi: 10.1016/j.msard.2017.03.008. Epub 2017 Mar 23.

    PubMed 28619432
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

    PubMed 6685237
  • Givon U, Zeilig G, Achiron A. Gait analysis in multiple sclerosis: characterization of temporal-spatial parameters using GAITRite functional ambulation system. Gait Posture. 2009 Jan;29(1):138-42. doi: 10.1016/j.gaitpost.2008.07.011. Epub 2008 Oct 31.

    PubMed 18951800
  • Thoumie P, Lamotte D, Cantalloube S, Faucher M, Amarenco G. Motor determinants of gait in 100 ambulatory patients with multiple sclerosis. Mult Scler. 2005 Aug;11(4):485-91. doi: 10.1191/1352458505ms1176oa.

    PubMed 16042234
  • Crenshaw SJ, Royer TD, Richards JG, Hudson DJ. Gait variability in people with multiple sclerosis. Mult Scler. 2006 Oct;12(5):613-9. doi: 10.1177/1352458505070609.

    PubMed 17086908
  • Gehlsen G, Beekman K, Assmann N, Winant D, Seidle M, Carter A. Gait characteristics in multiple sclerosis: progressive changes and effects of exercise on parameters. Arch Phys Med Rehabil. 1986 Aug;67(8):536-9.

    PubMed 3741079
  • Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.

    PubMed 16372431
  • Franceschini M, Rampello A, Bovolenta F, Aiello M, Tzani P, Chetta A. Cost of walking, exertional dyspnoea and fatigue in individuals with multiple sclerosis not requiring assistive devices. J Rehabil Med. 2010 Sep;42(8):719-23. doi: 10.2340/16501977-0600.

    PubMed 20809053
  • Gijbels D, Alders G, Van Hoof E, Charlier C, Roelants M, Broekmans T, Eijnde BO, Feys P. Predicting habitual walking performance in multiple sclerosis: relevance of capacity and self-report measures. Mult Scler. 2010 May;16(5):618-26. doi: 10.1177/1352458510361357. Epub 2010 Mar 5.

    PubMed 20207785

Questions about this trial

What is this clinical trial studying?

A study testing Wireless Lighting Reaction System Training(Agility plus Cognitive) in people with Multiple Sclerosis, run by Ege 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 4 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 9 Jan 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Functions (time frame: 8th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06874764, which also lists 33 linked publications.

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 9 Jan 2026.

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