Multiple SclerosisMS-BALGAITNCT07630311
"Balance, Gait, and Motion Analysis in Multiple Sclerosis"
An observational study of Multiple Sclerosis and Gait Disorders, Neurologic, run by University of Patras at 2 sites in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic, Postural Balance
- How many people
- 40 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Sep 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioannina Medical School
Ioannina, 45110
Avraam Ploumis, MD, PhD, +30 26510 99969, aploumis@uoi.gr
Avraam Ploumis, MD, PhD
- Recruiting
Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of Patras
Pátrai, 26504
Eirini Papakosta, PT, MSc cand, +30 6972355224, up1075912@ac.upatras.gr
Sofia Lampropoulou, PT, MSc, PhD, +30 2610 962410, lampropoulou@upatras.gr
About this study
Official title: "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:
Read more
- 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.
Read the 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 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.
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic, Postural Balance, Motion Analysis, Biomechanics, Kinetics
- Keywords
- Multiple Sclerosis, Balance, Gait, Motion Analysis, Vicon System, Functional Assessments, Physical Performance, Fatigue, Biomechanics
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Single laboratory session (~40 minutes per participant)
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.
Measured: Single laboratory session (~10 minutes per participant)
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.
Measured: Single laboratory session (~10 minutes per participant)
Secondary outcomes (5)
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.
Measured: Single laboratory session (~5 minutes per participant).
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.
Measured: Single laboratory session (~10 minutes per participant)
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.
Measured: Single laboratory session (~5 minuites per participant).
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.
Measured: Single laboratory session (~5 minutes per participant).
Spasticity Assessment: modified Ashworth Scale (mAS)
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.
Measured: Single laboratory session (~5 minutes per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Sep 2025
- Primary completion28 Feb 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ioannina
- Responsible party
- Principal investigator, Eirini Papakosta, University of Patras
- Investigators
- Sofia Lampropoulou, PT, MSc, PhD, Principal investigator, Department of Physiotherapy, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630311
- Sponsor's protocol ID
- 17510/10-09-2025
- Acronym
- MS-BALGAIT
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19013070Franchignoni 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.
PubMed 20461334Pereira 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.
PubMed 31689266Lampropoulou 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.
PubMed 29474129Lampropoulou, 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.
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.
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.
PubMed 31455119Billis 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.
PubMed 21219254Motl 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.
PubMed 27893568Valet 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.
PubMed 30311490Forsberg 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.
PubMed 32607064Bakalidou 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.
PubMed 23888275McLoughlin 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.
PubMed 25990573Paltamaa 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.
PubMed 16146327Meseguer-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.
PubMed 28901119
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Functional Assessment of Balance and Gait and Correlation With Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis: Cross-Sectional Study"
- ClinicalTrials.gov ID
- NCT07630311
- Acronym / sponsor ID
- MS-BALGAIT / 17510/10-09-2025
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic, Postural Balance, Motion Analysis, Biomechanics, Kinetics
- Keywords
- Multiple Sclerosis, Balance, Gait, Motion Analysis, Vicon System, Functional Assessments, Physical Performance, Fatigue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Collaborators
- University Hospital, Ioannina
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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)
Time frame: 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.
Gait Assessment: Functional Gait Assessment (FGA)
Time frame: 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.
5 secondary outcomes
Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)
Time frame: Single laboratory session (~5 minutes per participant).
Assessment of Physical Performance and Endurance: Short Physical Performance Battery (SPPB)
Time frame: Single laboratory session (~10 minutes per participant)
Assessment of Physical Performance and Endurance: 2-Minutes Walk Test
Time frame: Single laboratory session (~5 minuites per participant).
Fatigue Assessment: Fatigue Severity Scale (FSS)
Time frame: Single laboratory session (~5 minutes per participant).
Spasticity Assessment: modified Ashworth Scale (mAS)
Time frame: Single laboratory session (~5 minutes per participant).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 19013070McGinley 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.
- Background: PubMed 20461334Franchignoni 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.
- Background: PubMed 31689266Pereira 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.
- Background: PubMed 29474129Lampropoulou 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.
- BackgroundLampropoulou, 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.
- BackgroundLampropoulou, 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: PubMed 31455119Monjezi 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.
- Background: PubMed 21219254Billis 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.
- Background: PubMed 27893568Motl 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.
- Background: PubMed 30311490Valet 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.
- Background: PubMed 32607064Forsberg 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.
- Background: PubMed 23888275Bakalidou 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.
- Department of Physiotherapy, University of Patras, GreeceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofia Lampropoulou, PT, MSc, PhD principal investigator
Department of Physiotherapy, University of Patras
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Gait Disorders, Neurologic, run by University of Patras at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eirini Papakosta, PT, MSc cand. (+30 6972355224, up1075912@ac.upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetic and Kinematic Analysis (time frame: Single laboratory session (~40 minutes per participant)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07630311, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.