About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Kinetic and Kinematic Analysis
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).
Balance Assessment-Postural Control: Mini Balance Evaluation Systems Test (mini-BESTest)
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.
Gait Assessment: Functional Gait Assessment (FGA)
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.
Secondary outcomes
Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)
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.
Assessment of Physical Performance and Endurance: Short Physical Performance Battery (SPPB)
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.
Assessment of Physical Performance and Endurance: 2-Minutes Walk Test
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.
Fatigue Assessment: Fatigue Severity Scale (FSS)
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.
Sponsors and contacts
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University of Patras
Lead sponsor
University Hospital, Ioannina
Collaborator