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

June 1, 2026 updated by: 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 MS?

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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 MS. 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 MS. 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 MS and support the selection of clinically meaningful assessment tools for rehabilitation practice and future research.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Ioannina, Greece, 45110
        • Recruiting
        • Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioannina Medical School
        • Contact:
          • Avraam Ploumis, MD, PhD
          • Phone Number: +30 26510 99969
          • Email: aploumis@uoi.gr
        • Principal Investigator:
          • Avraam Ploumis, MD, PhD
        • Sub-Investigator:
          • Dimitrios Varvarousis, MD, PhD
        • Sub-Investigator:
          • Dimitrios Dimopoulos, PhD
      • Pátrai, Greece, 26504
        • Recruiting
        • Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of Patras
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Eirini Papakosta, PT, MSc cand
        • Principal Investigator:
          • Sofia Lampropoulou, PT, MSc, PhD
        • Sub-Investigator:
          • Sofia A Xergia, PT, MSc, PhD
        • Sub-Investigator:
          • Aikaterini Tatsi, PT, MSc
        • Sub-Investigator:
          • Spyridon Pappas, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Adults (≥ 18 years) with confirmed diagnosis of MS
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinetic and Kinematic Analysis
Time Frame: Single laboratory session (~40 minutes per participant)
Three-dimensional gait and balance analysis will be performed using a Vicon Nexus v2.16 motion-capture system (12 Vero cameras, 200 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 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 (McGinley et al.,2009).
Single laboratory session (~40 minutes per participant)
Balance Assessment-Postural Control: Mini Balance Evaluation Systems Test (mini-BESTest)
Time Frame: Single laboratory session (~10 min per participant)
The 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 MS (Franchignoni et al., 2010; Pereira et al., 2019) and its Greek cross-cultural adaptation has further confirmed the scale's reliability and validity within Greek-speaking clinical cohorts (Lampropoulou et al., 2016; Lampropoulou et al., 2019).
Single laboratory session (~10 min per participant)
Gait Assessment: Functional Gait Assessment (FGA)
Time Frame: Single laboratory session (~10 min per participant)
The 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 MS populations living (Forsberg et al., 2017). The Greek version of the scale will be employed in the present study (Lampropoulou et al., 2024)
Single laboratory session (~10 min per participant)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)
Time Frame: Single laboratory session (~5 min per participant).
The 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 (Billis et al., 2011). It is reliable and widely applied in Multiple Sclerosis and older-adult populations (Monjeri et al., 2021).
Single laboratory session (~5 min per participant).
Assessment of Physical Performance and Endurance: Short Physical Performance Battery (SPPB)
Time Frame: Single laboratory session (~10 min per participant)
The SPPB evaluates lower-limb function through three components: (1) standing balance, (2) 4-m 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 (Motl et al., 2018).
Single laboratory session (~10 min per participant)
Assessment of Physical Performance and Endurance: 2-Minute Walk Test
Time Frame: Single laboratory session (~5 min per participant).
The 2MWT measures walking endurance and fatigue by recording the total distance walked in 2 minutes on a flat 12-m 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 (Valet et al., 2019).
Single laboratory session (~5 min per participant).
Fatigue Assessment: Fatigue Severity Scale (FSS)
Time Frame: Single laboratory session (~5 min per participant).
The 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 (Bakalidou et al., 2013; McLoughlin et al., 2016).
Single laboratory session (~5 min per participant).
Spasticity Assessment: modified Ashworth Scale (mAS)
Time Frame: Single laboratory session (~5 min per participant).
The 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 (Paltamaa et al., 2005; Meseguer Henarejos et al., 2018).
Single laboratory session (~5 min per participant).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Collaborators

University Hospital, Ioannina

Investigators

  • Principal Investigator: Sofia Lampropoulou, PT, MSc, PhD, Department of Physiotherapy, University of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17510/10-09-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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