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

21 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

40

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Kinetic and Kinematic Analysis
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Patras

Współpracownicy

University Hospital, Ioannina

Śledczy

  • Główny śledczy: Sofia Lampropoulou, PT, MSc, PhD, Department of Physiotherapy, University of Patras

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 września 2025

Zakończenie podstawowe (Rzeczywisty)

28 lutego 2026

Ukończenie studiów (Szacowany)

30 sierpnia 2026

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 17510/10-09-2025

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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