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

Ege University

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Wireless Lighting Reaction System Training(Agility plus Cognitive)

Study type: Interventional

Funder types: Other

Identifiers

NCT06874764

25-5/4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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
• Drug and alcohol addiction
• Pregnancy, breastfeeding
• No chronic systemic disease preventing exercise
• Patients who cannot reach the targeted exercise level

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Training Group

Experimental group

Description:

The 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.

Treatment:

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

Control Group

No Intervention group

Description:

The control group will not receive any intervention. They will be asked to continue their normal lives.