이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Gait Adaptability in Persons With MS Having Mild Disability

2026년 5월 5일 업데이트: 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

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

32

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Diepenbeek, 벨기에, 3500
        • 모병
        • REVAL Rehabilitation Research Center, University of Hasselt
        • 연락하다:

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

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

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
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Walking Adaptability Ladder Test (WALT)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
다발성 경화증 보행 척도 (MSWS)
기간: Day 1
MSWS는 12개 항목을 포함하며 일상 생활에서 인지된 보행 어려움을 평가합니다. 높은 점수는 더 높은 다발성 경화증 관련 보행 장애를 나타냅니다.
Day 1
Fall history
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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 12월 5일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 12월 20일

연구 등록 날짜

최초 제출

2026년 3월 26일

QC 기준을 충족하는 최초 제출

2026년 5월 5일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 5일

마지막으로 확인됨

2026년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CME2024/032

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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. .