"Balance, Gait, and Motion Analysis in Multiple Sclerosis"

Официальное название

"Functional Assessment of Balance and Gait and Correlation With Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis: Cross-Sectional Study"

Обзор

The goal of this observational cross-sectional study is to investigate the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). The main questions it aims to answer are: i) What is the relationship between kinetic and kinematic gait and balance parameters measured using the Vicon motion analysis system and performance on clinical functional assessments in people with Multiple Sclerosis? ii) Which biomechanical parameters are most strongly associated with functional balance, gait, and physical performance outcomes? Participants will attend a single laboratory-based assessment session. During this session, they will undergo biomechanical gait and balance analysis using the Vicon motion capture system, complete functional assessments of balance, gait, and physical performance, complete questionnaires assessing fear of falling and fatigue, and undergo assessment of lower-limb spasticity.

Подробное описание

Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system characterized by demyelination and neurodegeneration. Impairments in balance and gait are among the most common manifestations of the disease and are associated with reduced mobility, increased risk of falls, decreased independence, and lower quality of life. Accurate assessment of these impairments is essential for clinical decision-making and the development of effective rehabilitation interventions.

Clinical functional assessments are widely used to evaluate balance, gait, and physical performance in individuals with Multiple Sclerosis. In parallel, advances in motion analysis technology have enabled the objective quantification of movement characteristics through kinetic and kinematic measurements. Although both approaches are commonly used in clinical and research settings, the relationship between objective biomechanical parameters and functional clinical outcomes remains insufficiently understood.

The purpose of this cross-sectional observational study is to investigate the associations between kinetic and kinematic measures of balance and gait obtained through three-dimensional motion analysis using the Vicon system and functional performance outcomes in people with Multiple Sclerosis. By examining these relationships, the study aims to identify biomechanical indicators that are most closely related to functional abilities and mobility limitations.

Participants will undergo a comprehensive laboratory-based assessment including biomechanical analysis of balance and gait, standardized functional performance testing, patient-reported outcome measures related to fear of falling and fatigue, and assessment of lower-limb spasticity. Correlation analyses will be conducted to explore the relationships between biomechanical and functional measures.

The findings of this study may contribute to a better understanding of the biomechanical determinants of functional performance in people with Multiple Sclerosis and support the selection of clinically meaningful assessment tools for rehabilitation practice and future research.

Первичные конечные точки

• Kinetic and Kinematic Analysis [Срок оценки: Single laboratory session (~40 minutes per participant)]
• Balance Assessment-Postural Control: Mini Balance Evaluation Systems Test (mini-BESTest) [Срок оценки: Single laboratory session (~10 minutes per participant)]
• Gait Assessment: Functional Gait Assessment (FGA) [Срок оценки: Single laboratory session (~10 minutes per participant)]

Вторичные конечные точки (5)

• Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I) [Срок оценки: Single laboratory session (~5 minutes per participant).]
• Assessment of Physical Performance and Endurance: Short Physical Performance Battery (SPPB) [Срок оценки: Single laboratory session (~10 minutes per participant)]
• Assessment of Physical Performance and Endurance: 2-Minutes Walk Test [Срок оценки: Single laboratory session (~5 minuites per participant).]
• Fatigue Assessment: Fatigue Severity Scale (FSS) [Срок оценки: Single laboratory session (~5 minutes per participant).]
• Spasticity Assessment: modified Ashworth Scale (mAS) [Срок оценки: Single laboratory session (~5 minutes per participant).]

Критерии участия

Критерии включения

• Adults (≥ 18 years) with confirmed diagnosis of Multiple Sclerosis
• Expanded Disability Status Scale (EDSS) score <6
• Ability to ambulate independently without the use of assistive devices
• Absence of significant orthopedic or neurological conditions affecting mobility
• Ability to understand and follow verbal instructions.

Критерии исключения

• History of injury or surgical intervention to the lower limbs or spine within the past year
• Any musculoskeletal, neurological, cardiovascular, or other medical condition, other than Multiple Sclerosis, that may significantly affect gait or balance or compromise participant safety during testing.
• Severe balance impairment or high risk of falling that prevents safe participation in single-leg stance, gait analysis, or obstacle negotiation tasks.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Греция · 2 центра

• Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioan — Ioannina
• Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of — Pátrai

Публикации

• McGinley JL, Baker R, Wolfe R, Morris ME. The reliability of three-dimensional kinematic gait measurements: a systematic review. Gait Posture. 2009 Apr;29(3):360-9. doi: 10.1016/j.gaitpost.2008.09.003. Epub 2008 Nov 13. PMID 19013070
• Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537. PMID 20461334
• Pereira ACAC, Xavier RF, Lopes AC, da Silva CCBM, Oliveira CC, Fernandes FLA, Stelmach R, Carvalho CRF. The Mini-Balance Evaluation System Test Can Predict Falls in Clinically Stable Outpatients With COPD: A 12-MO PROSPECTIVE COHORT STUDY. J Cardiopulm Rehabil Prev. 2019 Nov;39(6):391-396. doi: 10.1097/HCR.0000000000000427. PMID 31689266
• Lampropoulou SI, Billis E, Gedikoglou IA, Michailidou C, Nowicky AV, Skrinou D, Michailidi F, Chandrinou D, Meligkoni M. Reliability, validity and minimal detectable change of the Mini-BESTest in Greek participants with chronic stroke. Physiother Theory Pract. 2019 Feb;35(2):171-182. doi: 10.1080/09593985.2018.1441931. Epub 2018 Feb 23. PMID 29474129
• Lampropoulou, S., Gedikoglou, I.A., Michailidou, C. and Billis, E. (2016) 'Cross-cultural adaptation of Mini-Balance Evaluation Systems Test (mini-BESTest) into Greek', World Journal of Research & Review, 3(3), pp. 61-67.
• Lampropoulou, S., Kellari, A., Gedikoglou, I.A., Kozonaki, D.G., Nika, P. and Sakellari, V. (2024) 'Cross-Cultural Adaptation and Psychometric Characteristics of the Greek Functional Gait Assessment Scale in Healthy Community-Dwelling Older Adults', Applied Sciences, 14(2), p. 520. doi: 10.3390/app14020520.
• Monjezi S, Negahban H, Tajali S, Mofateh R, Molhemi F, Mostafaee N. Psychometric properties of the Persian-version of the Activities-specific Balance Confidence scale and Fall Efficacy Scale-International in Iranian patients with multiple sclerosis. Physiother Theory Pract. 2021 Aug;37(8):935-944. doi: 10.1080/09593985.2019.1658247. Epub 2019 Aug 27. PMID 31455119
• Billis E, Strimpakos N, Kapreli E, Sakellari V, Skelton DA, Dontas I, Ioannou F, Filon G, Gioftsos G. Cross-cultural validation of the Falls Efficacy Scale International (FES-I) in Greek community-dwelling older adults. Disabil Rehabil. 2011;33(19-20):1776-84. doi: 10.3109/09638288.2010.546937. Epub 2011 Jan 11. PMID 21219254

Идентификаторы

NCT: NCT07630311 · 17510/10-09-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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