"Balance, Gait, and Motion Analysis in Multiple Sclerosis" (MS-BALGAIT)
2026年6月21日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
40
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Eirini Papakosta, PT, MSc cand.
- 電話番号：+30 6972355224
- メール：up1075912@ac.upatras.gr
研究連絡先のバックアップ
- 名前：Sofia Lampropoulou, PT, MSc, PhD
- 電話番号：+30 2610 962410
- メール：lampropoulou@upatras.gr
研究場所
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Ioannina、ギリシャ、45110
- 募集
- Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioannina Medical School
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コンタクト：
- Avraam Ploumis, MD, PhD
- 電話番号：+30 26510 99969
- メール：aploumis@uoi.gr
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主任研究者：
- Avraam Ploumis, MD, PhD
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副調査官：
- Dimitrios Varvarousis, MD, PhD
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副調査官：
- Dimitrios Dimopoulos, PhD
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Pátrai、ギリシャ、26504
- 募集
- Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of Patras
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コンタクト：
- Sofia Lampropoulou, PT, MSc, PhD
- 電話番号：+30 2610 962410
- メール：lampropoulou@upatras.gr
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コンタクト：
- Eirini Papakosta, PT, MSc cand
- 電話番号：+30 6972355224
- メール：up1075912@ac.upatras.gr
-
副調査官：
- Eirini Papakosta, PT, MSc cand
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主任研究者：
- Sofia Lampropoulou, PT, MSc, PhD
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副調査官：
- Sofia A Xergia, PT, MSc, PhD
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副調査官：
- Aikaterini Tatsi, PT, MSc
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副調査官：
- Spyridon Pappas, PT
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Kinetic and Kinematic Analysis
時間枠：Single laboratory session (~40 minutes per participant)
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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).
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Single laboratory session (~40 minutes per participant)
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Balance Assessment-Postural Control: Mini Balance Evaluation Systems Test (mini-BESTest)
時間枠：Single laboratory session (~10 minutes per participant)
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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.
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Single laboratory session (~10 minutes per participant)
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Gait Assessment: Functional Gait Assessment (FGA)
時間枠：Single laboratory session (~10 minutes per participant)
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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.
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Single laboratory session (~10 minutes per participant)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)
時間枠：Single laboratory session (~5 minutes per participant).
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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.
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Single laboratory session (~5 minutes per participant).
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Assessment of Physical Performance and Endurance: Short Physical Performance Battery (SPPB)
時間枠：Single laboratory session (~10 minutes per participant)
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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.
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Single laboratory session (~10 minutes per participant)
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Assessment of Physical Performance and Endurance: 2-Minutes Walk Test
時間枠：Single laboratory session (~5 minuites per participant).
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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.
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Single laboratory session (~5 minuites per participant).
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Fatigue Assessment: Fatigue Severity Scale (FSS)
時間枠：Single laboratory session (~5 minutes per participant).
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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.
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Single laboratory session (~5 minutes per participant).
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Spasticity Assessment: modified Ashworth Scale (mAS)
時間枠：Single laboratory session (~5 minutes per participant).
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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.
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Single laboratory session (~5 minutes per participant).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Sofia Lampropoulou, PT, MSc, PhD、Department of Physiotherapy, University of Patras
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年9月1日
一次修了 (実際)
2026年2月28日
研究の完了 (推定)
2026年8月30日
試験登録日
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月21日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 17510/10-09-2025
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いいえ
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いいえ
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