"Balance, Gait, and Motion Analysis in Multiple Sclerosis" (MS-BALGAIT)
2026년 6월 21일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
40
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Eirini Papakosta, PT, MSc cand.
- 전화번호: +30 6972355224
- 이메일: up1075912@ac.upatras.gr
연구 연락처 백업
- 이름: Sofia Lampropoulou, PT, MSc, PhD
- 전화번호: +30 2610 962410
- 이메일: lampropoulou@upatras.gr
연구 장소
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Ioannina, 그리스, 45110
- 모병
- Division of Physical Medicine and Rehabilitation/Department of Surgery, University of Ioannina Medical School
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연락하다:
- Avraam Ploumis, MD, PhD
- 전화번호: +30 26510 99969
- 이메일: aploumis@uoi.gr
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수석 연구원:
- Avraam Ploumis, MD, PhD
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부수사관:
- Dimitrios Varvarousis, MD, PhD
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부수사관:
- Dimitrios Dimopoulos, PhD
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Pátrai, 그리스, 26504
- 모병
- Department of Physiotherapy of the School of Health Rehabilitation Sciences, University of Patras
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연락하다:
- Sofia Lampropoulou, PT, MSc, PhD
- 전화번호: +30 2610 962410
- 이메일: lampropoulou@upatras.gr
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연락하다:
- Eirini Papakosta, PT, MSc cand
- 전화번호: +30 6972355224
- 이메일: up1075912@ac.upatras.gr
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부수사관:
- Eirini Papakosta, PT, MSc cand
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수석 연구원:
- Sofia Lampropoulou, PT, MSc, PhD
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부수사관:
- Sofia A Xergia, PT, MSc, PhD
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부수사관:
- Aikaterini Tatsi, PT, MSc
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부수사관:
- Spyridon Pappas, PT
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Kinetic and Kinematic Analysis
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Balance Assessment-Fear of Falling: Fall Efficacy Scale-International (FES-I)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sofia Lampropoulou, PT, MSc, PhD, Department of Physiotherapy, University of Patras
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 9월 1일
기본 완료 (실제)
2026년 2월 28일
연구 완료 (추정된)
2026년 8월 30일
연구 등록 날짜
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 21일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 17510/10-09-2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .