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Набор по приглашению NCT06874764

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

Без фазы С лечением Multiple Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Wireless Lighting Reaction System Training(Agility plus Cognitive).
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Wireless Lighting Reaction System Training(Agility plus Cognitive)
    Agility training and Cognitive trainings(cognitive trainings ready within the device: Eye for detail, Hawk eye, Juggle Factor)

Первичные конечные точки

  • Cognitive Functions [Срок оценки: 8th week]
Вторичные конечные точки (12)
  • Balance assessment [Срок оценки: 8th week]
  • Anxiety and Depression Status [Срок оценки: 8th week]
  • Fatigue Assessment [Срок оценки: 8th week]
  • MS Quality of Life [Срок оценки: 8th week]
  • Static Posture Assessment(Static Balance) [Срок оценки: 8th week]
  • Static Posture Assessment(Visual Dependency) [Срок оценки: 8th week]
  • Static Posture Assessment(Proprioception Disturbance) [Срок оценки: 8th week]
  • Static Posture Assessment(Vestibular Dominant) [Срок оценки: 8th week]
  • Gait Analysis(Step length) [Срок оценки: 8th week]
  • Gait Analysis(Stride length) [Срок оценки: 8th week]
  • Gait Analysis(Step time) [Срок оценки: 8th week]
  • Gait Analysis(Step width) [Срок оценки: 8th week]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ege University Sport Medicine Clinic — Izmir

Публикации

  • 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. PMID 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. PMID 17086909
  • Pollock AS, Durward BR, Rowe PJ, Paul JP. What is balance? Clin Rehabil. 2000 Aug;14(4):402-6. doi: 10.1191/0269215500cr342oa. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 6685237

Идентификаторы

NCT: NCT06874764 · 25-5/4

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗