"Balance, Gait, and Motion Analysis in Multiple Sclerosis" (MS-BALGAIT)
21 de junio de 2026 actualizado por: Eirini Papakosta, University of Patras
"Functional Assessment of Balance and Gait and Correlation With Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis: Cross-Sectional Study"
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.
Descripción general del estudio
Estado
Reclutamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
40
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Eirini Papakosta, PT, MSc cand.
- Número de teléfono: +30 6972355224
- Correo electrónico: up1075912@ac.upatras.gr
Copia de seguridad de contactos de estudio
- Nombre: Sofia Lampropoulou, PT, MSc, PhD
- Número de teléfono: +30 2610 962410
- Correo electrónico: lampropoulou@upatras.gr
Ubicaciones de estudio
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Ioannina, Grecia, 45110
- Reclutamiento
- Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioannina Medical School
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Contacto:
- Avraam Ploumis, MD, PhD
- Número de teléfono: +30 26510 99969
- Correo electrónico: aploumis@uoi.gr
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Investigador principal:
- Avraam Ploumis, MD, PhD
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Sub-Investigador:
- Dimitrios Varvarousis, MD, PhD
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Sub-Investigador:
- Dimitrios Dimopoulos, PhD
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Pátrai, Grecia, 26504
- Reclutamiento
- Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of Patras
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Contacto:
- Sofia Lampropoulou, PT, MSc, PhD
- Número de teléfono: +30 2610 962410
- Correo electrónico: lampropoulou@upatras.gr
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Contacto:
- Eirini Papakosta, PT, MSc cand
- Número de teléfono: +30 6972355224
- Correo electrónico: up1075912@ac.upatras.gr
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Sub-Investigador:
- Eirini Papakosta, PT, MSc cand
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Investigador principal:
- Sofia Lampropoulou, PT, MSc, PhD
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Sub-Investigador:
- Sofia A Xergia, PT, MSc, PhD
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Sub-Investigador:
- Aikaterini Tatsi, PT, MSc
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Sub-Investigador:
- Spyridon Pappas, PT
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population will consist of adults with a confirmed diagnosis of Multiple Sclerosis (MS) who are able to walk independently and safely participate in balance and gait assessment procedures.
Participants will be recruited from two patient organizations in Western Greece: the "Friends and Persons with Multiple Sclerosis Association" of Northwestern Greece and the Hellenic Multiple Sclerosis Society of Western Greece.
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Individuals With Multiple Sclerosis
Individuals with a confirmed diagnosis of Multiple Sclerosis participating in a cross-sectional evaluation of balance, gait, physical performance, spasticity, fear of falling, and fatigue.
Participants will complete biomechanical gait and balance analysis using the Vicon motion capture system and a battery of standardized clinical assessments.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Kinetic and Kinematic Analysis
Periodo de tiempo: Single laboratory session (~40 minutes per participant)
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Three-dimensional gait and balance analysis will be performed using a Vicon Nexus version 2.16 motion-capture system (12 Vero cameras, 200 Hertz [Hz]) synchronized with two Bertec force plates (1000 Hz).
Reflective markers will record spatial coordinates for gait speed, step length, joint angles, and Center-of-Pressure (CoP) displacement.
This setup enables precise kinetic and kinematic quantification of balance and gait parameters and allows correlation with clinical functional tests in individuals with Multiple Sclerosis (MS).
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Single laboratory session (~40 minutes per participant)
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Balance Assessment-Postural Control: Mini Balance Evaluation Systems Test (mini-BESTest)
Periodo de tiempo: Single laboratory session (~10 minutes per participant)
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The mini Balance Evaluation Systems Test (mini-BESTest) assesses dynamic postural control across four domains: anticipatory adjustments, reactive responses, sensory orientation, and dynamic gait.
It includes 14 items scored on a 3-point scale (0 = severe impairment, 2 = normal performance); total = 28.
Higher scores indicate better balance.
It is validated and reliable for detecting fall risk in neurological populations, including Multiple Sclerosis and its Greek cross-cultural adaptation has further confirmed the scale's reliability and validity within Greek-speaking clinical cohorts.
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Single laboratory session (~10 minutes per participant)
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Gait Assessment: Functional Gait Assessment (FGA)
Periodo de tiempo: Single laboratory session (~10 minutes per participant)
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The Functional Gait Assessment (FGA) evaluates dynamic balance and gait adaptability under varying conditions.
It consists of 10 walking tasks (e.g., head turns, obstacle negotiation, pivot turns), each rated 0-3 (0 = severe impairment, 3 = normal).
Total = 30; higher scores indicate better functional gait performance and lower fall risk.
Demonstrates strong reliability and validity in neurological and Multiple Sclerosis populations living.
The Greek version of the scale will be employed in the present study.
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Single laboratory session (~10 minutes per participant)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)
Periodo de tiempo: Single laboratory session (~5 minutes per participant).
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The Fall Efficacy Scale-International (FES-I) assesses fear of falling and confidence in performing daily activities.
It consists of 16 self-report items, each rated 1-4 (1 = not at all concerned, 4 = very concerned).
Total score 16-64, with higher scores indicating greater fear of falling.
The Greek validated version will be used.
It is reliable and widely applied in Multiple Sclerosis and older-adult populations.
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Single laboratory session (~5 minutes per participant).
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Assessment of Physical Performance and Endurance: Short Physical Performance Battery (SPPB)
Periodo de tiempo: Single laboratory session (~10 minutes per participant)
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The Short Physical Performance Battery (SPPB) evaluates lower-limb function through three components: (1) standing balance, (2) 4-meter gait speed, and (3) repeated chair stands.
Each component is scored 0-4 based on performance time or ability, for a maximum total of 12 points.
Higher scores indicate better physical performance.
The SPPB is validated for assessing mobility, endurance, and fall risk in individuals with Multiple Sclerosis.
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Single laboratory session (~10 minutes per participant)
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Assessment of Physical Performance and Endurance: 2-Minutes Walk Test
Periodo de tiempo: Single laboratory session (~5 minuites per participant).
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The 2-Minutes Walk Test (2MWT) measures walking endurance and fatigue by recording the total distance walked in 2 minutes on a flat 12-meter walkway at a self-selected pace.
Results are expressed in meters.
Higher distances reflect better walking endurance and lower fatigue.
The test is validated for patients with Multiple Sclerosis and correlates with physical fitness and perceived fatigue.
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Single laboratory session (~5 minuites per participant).
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Fatigue Assessment: Fatigue Severity Scale (FSS)
Periodo de tiempo: Single laboratory session (~5 minutes per participant).
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The Fatigue Severity Scale (FSS) quantifies perceived fatigue through 9 self-report items, each scored 1-7 (1 = strongly disagree, 7 = strongly agree).
The mean of all items represents the final score; higher values indicate greater fatigue severity.
It is reliable, simple, and sensitive to changes in energy levels in Multiple Sclerosis and other neurological populations.
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Single laboratory session (~5 minutes per participant).
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Spasticity Assessment: modified Ashworth Scale (mAS)
Periodo de tiempo: Single laboratory session (~5 minutes per participant).
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The modified Ashworth Scale (mAS) assesses muscle tone and spasticity during passive movement of specific joints.
Each muscle group is rated on a 6-point ordinal scale (0 = no increase in tone; 1, 1+, 2, 3, 4 = progressively increasing resistance or rigidity).
Higher scores indicate greater spasticity.
The scale demonstrates strong intra- and inter-rater reliability in Multiple Sclerosis.
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Single laboratory session (~5 minutes per participant).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sofia Lampropoulou, PT, MSc, PhD, Department of Physiotherapy, University of Patras
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- Meseguer-Henarejos AB, Sanchez-Meca J, Lopez-Pina JA, Carles-Hernandez R. Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Aug;54(4):576-590. doi: 10.23736/S1973-9087.17.04796-7. Epub 2017 Sep 13.
- Forsberg A, Andreasson M, Nilsagard Y. The Functional Gait Assessment in People with Multiple Sclerosis: Validity and Sensitivity to Change. Int J MS Care. 2017 Mar-Apr;19(2):66-72. doi: 10.7224/1537-2073.2015-061.
- Paltamaa J, West H, Sarasoja T, Wikstrom J, Malkia E. Reliability of physical functioning measures in ambulatory subjects with MS. Physiother Res Int. 2005;10(2):93-109. doi: 10.1002/pri.30.
- 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.
- 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.
- 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.
- 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.
- Motl RW, Chaparro G, Hernandez ME, Balto JM, Sandroff BM. Physical Function in Older Adults With Multiple Sclerosis: An Application of the Short Physical Performance Battery. J Geriatr Phys Ther. 2018 Jul/Sep;41(3):155-160. doi: 10.1519/JPT.0000000000000115.
- Valet M, Lejeune T, Devis M, van Pesch V, El Sankari S, Stoquart G. Timed Up-and-Go and 2-Minute Walk Test in patients with multiple sclerosis with mild disability: reliability, responsiveness and link with perceived fatigue. Eur J Phys Rehabil Med. 2019 Aug;55(4):450-455. doi: 10.23736/S1973-9087.18.05366-2. Epub 2018 Oct 4.
- Bakalidou D, Skordilis EK, Giannopoulos S, Stamboulis E, Voumvourakis K. Validity and reliability of the FSS in Greek MS patients. Springerplus. 2013 Jul 5;2(1):304. doi: 10.1186/2193-1801-2-304. Print 2013 Dec.
- McLoughlin JV, Barr CJ, Patritti B, Crotty M, Lord SR, Sturnieks DL. Fatigue induced changes to kinematic and kinetic gait parameters following six minutes of walking in people with multiple sclerosis. Disabil Rehabil. 2016;38(6):535-43. doi: 10.3109/09638288.2015.1047969. Epub 2015 May 20.
- Severini G, Manca M, Ferraresi G, Caniatti LM, Cosma M, Baldasso F, Straudi S, Morelli M, Basaglia N. Evaluation of Clinical Gait Analysis parameters in patients affected by Multiple Sclerosis: Analysis of kinematics. Clin Biomech (Bristol). 2017 Jun;45:1-8. doi: 10.1016/j.clinbiomech.2017.04.001. Epub 2017 Apr 3.
- Sosnoff JJ, Sandroff BM, Motl RW. Quantifying gait abnormalities in persons with multiple sclerosis with minimal disability. Gait Posture. 2012 May;36(1):154-6. doi: 10.1016/j.gaitpost.2011.11.027. Epub 2012 Mar 17.
- Molina-Rueda F, Fernandez-Vazquez D, Navarro-Lopez V, Miangolarra-Page JC, Carratala-Tejada M. The Timing of Kinematic and Kinetic Parameters during Gait Cycle as a Marker of Early Gait Deterioration in Multiple Sclerosis Subjects with Mild Disability. J Clin Med. 2022 Mar 29;11(7):1892. doi: 10.3390/jcm11071892.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2025
Finalización primaria (Actual)
28 de febrero de 2026
Finalización del estudio (Estimado)
30 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Esclerosis múltiple
- Fatiga
- Trastornos de la marcha, neurológicos
Otros números de identificación del estudio
- 17510/10-09-2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .