"Balance, Gait, and Motion Analysis in Multiple Sclerosis"

NCT07630311 | Recruiting

• 1 other identifier: 17510/10-09-2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic; Postural Balance; Motion Analysis; Biomechanics; Kinetics; Kinematics; Physiotherapy; Fatigue; Fall

Keywords

Multiple Sclerosis; Balance; Gait; Motion Analysis; Vicon System; Functional Assessments; Physical Performance; Fatigue; Biomechanics

Outcome Measures

Primary Outcomes (3)

• Kinetic and Kinematic Analysis

  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)

  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)

  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 Outcomes (5)

• Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)

  Single laboratory session (~5 min per participant).

• Assessment of Physical Performance and Endurance: Short Physical Performance Battery (SPPB)

  Single laboratory session (~10 min per participant)

• Assessment of Physical Performance and Endurance: 2-Minute Walk Test

  Single laboratory session (~5 min per participant).

• Fatigue Assessment: Fatigue Severity Scale (FSS)

  Single laboratory session (~5 min per participant).

• Spasticity Assessment: modified Ashworth Scale (mAS)

  Single laboratory session (~5 min per participant).

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ioannina: collaborator
• University of Patras: lead

Study Sites (2)

Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioannina Medical School

Ioannina, 45110, Greece

RECRUITING

Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of Patras

Pátrai, 26504, Greece

RECRUITING

Related Publications (18)

• 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.

  PMID: 19013070 BACKGROUND

• 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.

  PMID: 20461334 BACKGROUND

• 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.

  PMID: 31689266 BACKGROUND

• 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.

  PMID: 29474129 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31455119 BACKGROUND

• 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.

  PMID: 21219254 BACKGROUND

• 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.

  PMID: 27893568 BACKGROUND

• 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.

  PMID: 30311490 BACKGROUND

• 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.

  PMID: 32607064 BACKGROUND

• 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.

  PMID: 23888275 BACKGROUND

• 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.

  PMID: 25990573 BACKGROUND

• 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.

  PMID: 16146327 BACKGROUND

• 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.

  PMID: 28901119 BACKGROUND

• 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.

  PMID: 28390935 BACKGROUND

• 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.

  PMID: 22424761 BACKGROUND

• 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.

  PMID: 35407499 BACKGROUND

Related Links

• Department of Physiotherapy, University of Patras, Greece

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sofia Lampropoulou, PT, MSc, PhD

  Department of Physiotherapy, University of Patras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eirini Papakosta, PT, MSc cand.

CONTACT

+30 6972355224; up1075912@ac.upatras.gr

Sofia Lampropoulou, PT, MSc, PhD

CONTACT

+30 2610 962410; lampropoulou@upatras.gr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Candidate

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)