An observational study in Multiple Sclerosis and Healthy Adults, sponsored by Hasselt University. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Hasselt University · Observational
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:
Secondary aims:
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 32 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Hasselt University is the lead sponsor of 204 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
People presenting with multiple sclerosis diagnosis according to the 2017 revisions of the Mcdonald's criteria.
Inclusion criteria for healthy controls: inclusion of age between 18 and 65 years old, sex- and age-matched on a group level.
Walking Adaptability Ladder Test (WALT)
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.
Time frame: Day 1
Reactive gait adaptations
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.
Time frame: Day 1
Relative concentration of oxyhemoglobin and deoxyhemoglobin
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).
Time frame: Day 1
Fall history
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.
Time frame: Day 1
The Modified Fatigue Impact Scale (MFIS)
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.
Time frame: Day 1
The Multiple Sclerosis Walking Scale (MSWS)
MSWS includes 12 items and assesses perceived walking difficulties in daily life. Higher scores show higher MS-related walking impairment.
Time frame: Day 1
Symbol Digit Modalities Test (SDMT)
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.
Time frame: Day 1
Brief Visuospatial Memory Test-Revised (BVMT-R)
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).
Time frame: Day 1
Gait-Specific Attention Profile (GSAP)
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).
Time frame: Day 1
Balance Recovery Scale (BRC)
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.
Time frame: Day 1
MiniBest Test
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.
Time frame: Day 1
2-Minute Stepping Test (2MST)
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.
Time frame: Day 1
Foot tap test (FTP)
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.
Time frame: Day 1
The Six-Spot Step Test (SSST)
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.
Time frame: Day 1
The 6-Minute Walk Test (6MWT)
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.
Time frame: Day 1
The Heel Rise Test (HRT)
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.
Time frame: Day 1
The Timed-25 Foot Walk (T25FW)
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.
Time frame: Day 1
Activities Specific Balance Confidence Scale (ABC)
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.
Time frame: Day 1
Concern about falling
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.
Time frame: Day 1
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Sep 2026, 8 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.