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Gait Adaptability in Persons With MS Having Mild Disability

2026年5月5日 更新者:Peter Feys、Hasselt University

Multidimensional Assessment of Gait Adaptability in Persons Multiple Sclerosis With no to Mild Disability

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that frequently leads to walking impairment, balance deficits, fatigue, cognitive difficulties, and an increased risk of falls. Importantly, these problems can already be present in the early stages of the disease and may not be adequately captured by standard clinical walking tests, which primarily assess speed or distance. Such tests are often insufficient to reflect the complexity of real-life walking, which requires continuous adaptation to environmental challenges, and attention to internal and external stimuli.

Gait adaptability, the ability to modify walking patterns in response to changing and unpredictable demands such as obstacles or sudden perturbations, is critical for safe mobility and fall prevention. Both proactive (anticipatory) and reactive (feedback-driven) gait adaptations are essential for maintaining balance and functional independence. However, gait adaptability and its underlying neural mechanisms remain insufficiently understood in people with MS.

This study aims to provide a comprehensive assessment of gait adaptability in people with MS by evaluating both proactive and reactive gait adaptations using objective gait measurements and cortical activity recordings. The findings may contribute to the development of more sensitive outcome measures and inform targeted rehabilitation strategies that better reflect real-life mobility demands.

Primary aims:

• To investigate the behavioral measures and neural correlates of reactive and proactive gait adaptability in pwMS compared to HC

Secondary aims:

  • To investigate factors related to gait adaptability
  • To investigate changes in gait adaptability during prolonged walking conditions

調査の概要

状態

募集

詳細な説明

A total of 16 persons with MS will be recruited. In addition, 16 healthy controls, matched for age and sex, will be recruited for comparison. Participants will be recruited by researchers from the REVAL Research Center at Hasselt University using the REVAL website and social media platforms, as well as those of relevant organizations. Healthy control participants will be recruited via flyers and social media, with age- and sex-matching applied using a 5-year age range.

The study consists of a single testing session. Outcomes will be recorded using time- and observation-based methods, and movement sensors will be used for motor performance tests, including the Timed 25-Foot Walk Test, Foot Tap Test, Heel Rise Test, 2-Minute Stepping Test, Six-Spot Step Test, and the 6-Minute Walk Test. Self-report questionnaires, including the Falls Efficacy Scale-International, Multiple Sclerosis Walking Scale, Modified Fatigue Impact Scale, Activities-specific Balance Confidence Scale, Gait-Specific Attention Profile, and Balance Recovery Confidence Scale, will be administered. The Mini-BESTest and cognitive tests, including SDMT and BVMT-R will be performed to assess balance and cognitive functions.

Proactive gait adaptability will be assessed using an overground gait adaptability test (i.e., the Walking Adaptability Ladder Test). Participants will walk along a 10-meter walkway with stepping targets indicated by bars and rows that progressively decrease in size. They will be instructed to adapt their steps to the targets while walking at a fast pace. Three conditions will be performed, each lasting 20 seconds and repeated five times, with 15 seconds of rest between trials during which participants will stand upright. The conditions include walking with one step per target, walking with two steps per target, and a control walking condition consisting of usual walking over the 10-meter walkway at the fastest safe walking speed without running. Reactive gait adaptability will be evaluated using an instrumented augmented reality system (Computer Assisted Rehabilitation Environment Extended [CAREN]; Motekforce Link, The Netherlands). Twelve unannounced repetitive perturbations will be applied. The CAREN system is designed for biomechanical analysis of human movement and utilizes high-resolution recordings via a 3D motion capture system equipped with 18 Vicon cameras (Vicon Motion Systems, Oxford, UK). The dual-belt treadmill incorporates two embedded force plates and allows for self-paced speed adjustments. Clinically relevant spatiotemporal gait parameters and gait stability measures will be processed. Cortical brain hemodynamics will be assessed using functional near-infrared spectroscopy (fNIRS; NIRSport™, NIRx, Germany), composed of 16 sources and 16 detectors. The fNIRS cap will be worn during both proactive and reactive gait adaptability conditions.

研究の種類

観察的

入学 (推定)

32

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

研究連絡先のバックアップ

研究場所

      • Diepenbeek、ベルギー、3500
        • 募集
        • REVAL Rehabilitation Research Center, University of Hasselt
        • コンタクト:

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

はい

サンプリング方法

非確率サンプル

調査対象母集団

A total of 16 persons with MS will be recruited. 16 healthy controls, matched for age (considering a 5-year range per subject) and sex, will be recruited for comparison.

説明

Inclusion Criteria:

  • Age between 18-65 years,
  • confirmed diagnosis of definite MS,
  • relapse free at least 30 days,
  • Expanded Disability Status Scale (EDSS) score between 0 and 3.5

Exclusion Criteria:

  • Diagnosed with neurological disease other than MS
  • cognitive decline that renders the patient incapable of performing tests and questionnaires.
  • Other neurological, orthopedic, or visual impairments affecting gait

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
Multiple sclerosis
People presenting with multiple sclerosis diagnosis according to the 2017 revisions of the Mcdonald's criteria.
Healthy controls
Inclusion criteria for healthy controls: inclusion of age between 18 and 65 years old, sex- and age-matched on a group level.

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
Walking Adaptability Ladder Test (WALT)
時間枠:Day 1
WALT is a measure of walking adaptability. It has stepping targets that successively decrease in size, which forces a person to continually adapt step length and cadence to the targets. All trials will be video recorded for the calculation of completion time (in seconds) and stepping errors and additionally recorded using inertial movement sensors.
Day 1
Reactive gait adaptations
時間枠:Day 1
Instrumented reactive gait adaptability will be evaluated using the safe augmented reality system (The Computer Assisted Rehabilitation Environment Extended- CAREN; Motekforce Link, NL). 12 unannounced repetitive perturbations will be applied. Margin of stability, center of mass velocity and range, step width, step length, and knee kinematics will be recorded by the Vicon Motion System (VICON, Oxford, UK). Adaptation across perturbations will be assessed by examining changes in these parameters over successive trials.
Day 1
Relative concentration of oxyhemoglobin and deoxyhemoglobin
時間枠:Day 1
The cortical brain hemodynamics during walking will be assessed through fNIRS (NIRSport TM, NIRX, Germany) composed of 16 sources and 16 detectors (wavelengths 760- 850nm). The hemodynamic signals will be recorded at a sampling rate of 10.25 Hz. A standard cap will be placed over each participant's scalp, and sources and detectors will be positioned on the measuring cap according to the 10-20 International system. The spatial distribution of the optodes on the cap will be chosen to create channels (i.e., source-detector pairs) with standard inter-optode distances of a maximum 3 cm. Optodes will be placed over both hemispheres to collect hemodynamic activity in bilateral PFC (Broadman areas 9,46 and 11), PMC (Broadman area 6), SMA (Broadman area 6), and Posterior parietal cortex (PPC-BA5,7).
Day 1

その他の成果指標

結果測定
メジャーの説明
時間枠
多発性硬化症歩行スケール (MSWS)
時間枠:1日目
MSWSは12項目から構成され、日常生活における歩行困難の認識を評価します。 高いスコアは、MS関連の歩行障害の程度が高いことを示します。
1日目
Fall history
時間枠:Day 1
The number of falls in the last 6 months will be questioned to compare the difficulties with (perceived) dual tasking between fallers and non-fallers. A fall will be described as "an event where the participant unintentionally landed on the ground or a lower level." Two questions will be asked to determine fall status and falls numbers: "Have you ever fallen in the last six months?" If the response is yes, "How many times have you fallen?" will be asked.
Day 1
The Modified Fatigue Impact Scale (MFIS)
時間枠:Day 1
MFIS is a self-reported questionnaire that evaluates the effects of physical (9-items), psychosocial (2-items), and cognitive (10-items) dimensions of fatigue. Higher scores show a higher perceived level of fatigue.
Day 1
Symbol Digit Modalities Test (SDMT)
時間枠:Day 1
Oral version of the SDMT will be used to evaluate cognitive processing speed. The participants will be asked to match as many numbers and symbols as possible within 90 s. The number of correct matches will be recorded.
Day 1
Brief Visuospatial Memory Test-Revised (BVMT-R)
時間枠:Day 1
BVMT-R will be used to assess short term visuospatial memory. The participant has 3 attempts, viewing the same figures 3 times. Each attempt can have a maximum score of 12 and the scores are summed together in a total score (0-36).
Day 1
Gait-Specific Attention Profile (GSAP)
時間枠:Day 1
GSAP includes four psychological constructs (anxiety, conscious movement processing, fall-related ruminations, processing efficiency) implicated in influencing the control of balance and gait. It includes 11 items; items are rated 1 (not at all) to 5 (very much so).
Day 1
Balance Recovery Scale (BRC)
時間枠:Day 1
BRC evaluates compensatory stepping responses and balance recovery strategies following perturbations. It includes a series of externally induced balance challenges in multiple directions. The scale helps to identify impaired reactive balance control. The total score ranges from 0 to 190. A higher score shows a higher certainty of arresting a fall.
Day 1
MiniBest Test
時間枠:Day 1
The Mini-BESTest assesses dynamic balance across four domains: anticipatory postural adjustments, reactive postural control, sensory orientation, and gait. It consists of 14 tasks scored on a 3-point scale (0-2), yielding a total score ranging from 0 to 28, with higher scores indicating better balance performance. The test has been validated in various populations, including individuals with neurological disorders.
Day 1
2-Minute Stepping Test (2MST)
時間枠:Day 1
2MST measures aerobic endurance and lower limb function and serves as a practical and space-efficient alternative to walking tests. Participants step in place for two minutes, raising their knees to a target height, and the number of full steps is recorded, frequency and amplitude will be recorded by inertial movement sensors.
Day 1
Foot tap test (FTP)
時間枠:Day 1
Distal motor coordination and speed will be assessed by rapid foot taps performed at the maximal comfortable speed and amplitude for 10 seconds and 1 minute per foot. Tap frequency and amplitude will be derived from the movement sensor data.
Day 1
The Six-Spot Step Test (SSST)
時間枠:Day 1
SSST will be used to evaluate dynamic balance and coordinated lower limb function. Participants will be asked to step as quickly as possible over six evenly spaced foam blocks arranged on the floor, following a standardized sequence.
Day 1
The 6-Minute Walk Test (6MWT)
時間枠:Day 1
6MWT will be used to assess walking endurance. Participants will be instructed to walk back and forth along a 30m, flat corridor for six minutes, covering as much distance as possible. Spatiotemporal parameters (speed, cadence, step length, step duration, double support), variability, and asymmetry metrics will be evaluated by inertial movement sensors.
Day 1
The Heel Rise Test (HRT)
時間枠:Day 1
HRT evaluates the strength and endurance of the calf muscles. Participants perform repeated single-leg heel raises (at least 5 cm) until fatigue or failure.
Day 1
The Timed-25 Foot Walk (T25FW)
時間枠:Day 1
T25FW will be applied to evaluate the fastest walking speed. The test will be carried out on a flat pathway, 7.62 m long. The participants will be instructed to walk as quickly and safely as possible. The average score of the two trials will be reported.
Day 1
Activities Specific Balance Confidence Scale (ABC)
時間枠:Day 1
ABC is used to assess participants' self-perceived confidence in maintaining balance while performing various daily activities. It includes 16 items; each rated from 0% (no confidence) to 100% (completely confident). The average score is calculated, with higher scores reflecting greater balance confidence.
Day 1
Concern about falling
時間枠:Day 1
The Falls Efficacy Scale International (FES-I) will be used to evaluate concerns about falling. The questionnaire consists of 16 items, each scored on a 4-point scale (1-4), resulting in a total score ranging from 16 to 64. Higher scores indicate greater concern about falling.
Day 1

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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12月5日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年12月20日

試験登録日

最初に提出

2026年3月26日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月12日

QC基準を満たした最後の更新が送信されました

2026年5月5日

最終確認日

2026年3月1日

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