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"Balance, Gait, and Motion Analysis in Multiple Sclerosis" (MS-BALGAIT)

21. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

40

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Řecko
      • Ioannina, Řecko, 45110
        • Nábor
        • Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioannina Medical School
        • Kontakt:
          • Avraam Ploumis, MD, PhD
          • Telefonní číslo: +30 26510 99969
          • E-mail: aploumis@uoi.gr
        • Vrchní vyšetřovatel:
          • Avraam Ploumis, MD, PhD
        • Dílčí vyšetřovatel:
          • Dimitrios Varvarousis, MD, PhD
        • Dílčí vyšetřovatel:
          • Dimitrios Dimopoulos, PhD
      • Pátrai, Řecko, 26504
        • Nábor
        • Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of Patras
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Eirini Papakosta, PT, MSc cand
        • Vrchní vyšetřovatel:
          • Sofia Lampropoulou, PT, MSc, PhD
        • Dílčí vyšetřovatel:
          • Sofia A Xergia, PT, MSc, PhD
        • Dílčí vyšetřovatel:
          • Aikaterini Tatsi, PT, MSc
        • Dílčí vyšetřovatel:
          • Spyridon Pappas, PT

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Kinetic and Kinematic Analysis
Časové okno: Single laboratory session (~40 minutes per participant)
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).
Single laboratory session (~40 minutes per participant)
Balance Assessment-Postural Control: Mini Balance Evaluation Systems Test (mini-BESTest)
Časové okno: Single laboratory session (~10 minutes per participant)
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.
Single laboratory session (~10 minutes per participant)
Gait Assessment: Functional Gait Assessment (FGA)
Časové okno: Single laboratory session (~10 minutes per participant)
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.
Single laboratory session (~10 minutes per participant)

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Patras

Spolupracovníci

University Hospital, Ioannina

Vyšetřovatelé

  • Vrchní vyšetřovatel: Sofia Lampropoulou, PT, MSc, PhD, Department of Physiotherapy, University of Patras

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. září 2025

Primární dokončení (Aktuální)

28. února 2026

Dokončení studie (Odhadovaný)

30. srpna 2026

Termíny zápisu do studia

První předloženo

1. června 2026

První předloženo, které splnilo kritéria kontroly kvality

1. června 2026

První zveřejněno (Aktuální)

5. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 17510/10-09-2025

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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