Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.

Официальное название

Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis: Effects on Functional, Motor and Cognitive Outcomes (ROAR-MS).

Обзор

Multiple sclerosis (MS) is a chronic, inflammatory and neurodegenerative disease of the central nervous system that often results in motor and/or cognitive impairment. Epidemiologically, the onset occurs between the ages of 20 and 40, with a peak around the age of 30. MS is an extremely heterogeneous disease in terms of signs and symptoms, both in terms of the neurological systems involved and the degree of impairment and severity. The most common symptoms include, among others, difficulty walking and lack of balance. The lack of stability and coordination reduces independence and mobility, predisposing people with MS to accidental falls and compromising mobility in daily life. Another symptom that characterises MS is cognitive impairment, which mainly alters information processing speed and short- and long-term memory. MS-related cognitive impairment is detectable at every stage of the disease. Very often, people with MS have co-existing cognitive and motor deficits, which add to the complexity of managing MS. In order to address this condition, a treatment strategy that combines cognitive and motor rehabilitation needs to be identified. Despite the increasing availability of effective drug therapies that may impact on balance, rehabilitation is a very important means to counteract the progression of disability and improve physical function, affecting social participation and improving quality of life. In recent years, rehabilitation makes use of various robotic devices, which are based on repeatable, intense and motivating exercises, integrated with an enriched virtual environment, capable of improving the quality of movement. In light of the literature, which mainly focuses on robotic therapy for walking, this pilot study aims to evaluate the effects of a specific robotic treatment for balance in MS patients. The primary objective of the study is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) on static balance. The secondary objective is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) 1. on dynamic balance and walking (assessed with clinical and instrumental scales) 2. on fatigue and cognitive performance in terms of sustained attention, dual-task cost and cognitive-motor interference; 3. on quality of life.

Подробное описание

Twenty-four patients of both sexes will be recruited, evaluated and treated at the Multiple Sclerosis UOS of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome from the date of approval of the study by the ethics committee and for the following 12 months, meeting the inclusion criteria. Patients will be divided into two groups by randomisation: one group (experimental group, HO, Hunova-Observation) will perform specific rehabilitation for balance disorder using the robotic platform Hunova® Movendo Technology srl, Genova, IT), followed by 4 weeks of observation. The other group (OH, Observation-Hunova) will instead carry out 4 weeks of observation, at the end of which they will carry out the specific treatment for the balance disorder using the robotic platform Hunova® Movendo Technology srl, Genova, IT).

Вмешательства

• Устройство Technological rehabilitation
  Specific rehabilitation for balance disorder using the robotic platform

Первичные конечные точки

• Berg Balance Scale [Срок оценки: Change from Baseline BBS at 4 and 8 weeks]

Вторичные конечные точки (12)

• Modified Fatigue Impact Scale (MFIS) [Срок оценки: Change from Baseline MFIS at 4 and 8 weeks]
• Fatigue Scale for Motor and Cognitive Function (FSMC) [Срок оценки: Change from Baseline FSMC at 4 and 8 weeks]
• Timed Up and Go test (TUG) [Срок оценки: Change from Baseline TUG at 4 and 8 weeks]
• Ambulation Index (AI) [Срок оценки: Change from Baseline Ambulation Index at 4 and 8 weeks]
• Walking handicap scale (WHS) [Срок оценки: Change from Baseline Walking handicap scale at 4 and 8 weeks]
• Functional Ambulation Classification (FAC) [Срок оценки: Change from Baseline Functional Ambulation Classification at 4 and 8 weeks]
• 10 Meter Walk Test (10mWT) [Срок оценки: Change from Baseline 10 Meter Walk Test at 4 and 8 weeks]
• Six-minute walk test (6MWT) [Срок оценки: Change from Baseline Six-minute walk test at 4 and 8 weeks]
• Multiple Sclerosis Walking Scale (MSWS-12) [Срок оценки: Change from Baseline Multiple Sclerosis Walking Scale at 4 and 8 weeks]
• Modified Barthel Index (mBI) [Срок оценки: Change from Baseline mBI at 4 and 8 weeks]
• Multiple Sclerosis Impact Scale (MSIS-29) [Срок оценки: Change from Baseline MSIS-29 at 4 and 8 weeks]
• Beck Depression Inventory-II (BDI-II) [Срок оценки: Change from Baseline BDI-II at 4 and 8 weeks]

Критерии участия

Критерии включения

• Definitive diagnosis of multiple sclerosis according to McDonald criteria;
• Age between 18 and 65 years;
• Pyramidal or cerebellar system with a score ≥ 2 on the EDSS;
• EDSS between 2 and 3;
• Ability to stand without support for 60 seconds;
• Stability of disease-modifying treatment and absence of clinical relapse of the disease for at least 1 year;
• Cognitive ability to execute simple orders and understand the physiotherapist's instructions \[assessed by Token Test (score ≥ 26.5)\];
• Ability to understand and sign informed consent.

Критерии исключения

• Significant visual impairment, defined by a visual system score ≥ 2 on the EDSS;
• Presence of vestibular disorders unrelated to MS;
• Presence of psychiatric disorders or severe cognitive impairment, i.e. a Mini Mental State Examination (MMSE) score < 24 (15);
• Presence of cardiovascular and respiratory disorders;
• Inability to provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Публикации

• Kamm CP, Uitdehaag BM, Polman CH. Multiple sclerosis: current knowledge and future outlook. Eur Neurol. 2014;72(3-4):132-41. doi: 10.1159/000360528. Epub 2014 Jul 30. PMID 25095894
• 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
• Morris ME, Cantwell C, Vowels L, Dodd K. Changes in gait and fatigue from morning to afternoon in people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2002 Mar;72(3):361-5. doi: 10.1136/jnnp.72.3.361. PMID 11861697
• Cattaneo D, Jonsdottir J. Sensory impairments in quiet standing in subjects with multiple sclerosis. Mult Scler. 2009 Jan;15(1):59-67. doi: 10.1177/1352458508096874. Epub 2008 Oct 9. PMID 18845654
• Sosnoff JJ, Shin S, Motl RW. Multiple sclerosis and postural control: the role of spasticity. Arch Phys Med Rehabil. 2010 Jan;91(1):93-9. doi: 10.1016/j.apmr.2009.09.013. PMID 20103402
• 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
• van Asch, P. Impact of mobility impairment in multiple sclerosis 2-patients' perspectives. European Neurological Review. 2011; 6(2), 115-120. https://doi.org/10.17925/ENR.2011.06.02.115
• Benedict RH, Cookfair D, Gavett R, Gunther M, Munschauer F, Garg N, Weinstock-Guttman B. Validity of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). J Int Neuropsychol Soc. 2006 Jul;12(4):549-58. doi: 10.1017/s1355617706060723. PMID 16981607

Идентификаторы

NCT: NCT05983809 · 0000051/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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