An observational study in Multiple Sclerosis and Healthy Controls Group - Age and Sex-matched, sponsored by Hasselt University. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Hasselt University · Observational
Walking and motor control impairments are among the most common manifestations experienced by people with multiple sclerosis (pwMS) and may already be present in individuals with mild disability. Subtle changes in walking performance can reflect early disease progression, highlighting the need for sensitive clinical outcome measures that capture complex, real-world mobility. Commonly used assessments primarily quantify time or distance and may lack sensitivity to detect early or subtle functional changes in daily-life walking. Successful everyday mobility requires gait adaptability, defined as the ability to continuously adjust walking patterns in response to environmental or task-related challenges, including the processing of external perturbations and internal factors such as fatigue, balance confidence, and fear of falling. Despite its clinical relevance, gait adaptability is not specifically addressed by currently validated clinical tests in pwMS. The Walking Adaptability Ladder Test (WALT), which challenges the interaction between step length, cadence, and walking speed through continuous adjustments, and the Foot Tap Test (FTT), which assesses lower limb motor control and rhythmic coordination, have demonstrated promising measurement properties in other populations but have not yet been evaluated in pwMS. The primary aim of this study is to examine the test-retest reliability and construct validity of the WALT and FTT in pwMS with mild disability. Secondary aims include evaluating the measurement properties of the Balance Recovery Scale and the Gait-Specific Attention Scale in pwMS with mild disability, identifying inertial measurement unit-derived metrics that best discriminate pwMS with low disability from healthy controls, and exploring whether relationships between clinical motor test outcomes and self-reported measures provide complementary insights into subtle gait impairments.
A total of 50 persons with multiple sclerosis (pwMS; EDSS 0-3.5) and 50 healthy controls matched for age (within a 5-year range) and sex will be recruited from the University of León, Ponferrada, and Hospital Universitario de Ponferrada El Bierzo. Test-retest reliability will be assessed exclusively in Spain at these sites, where the specified measurements will be repeated for retest purposes. For validation analyses, single-time-point measurements will be combined with data collected in Italy at the University of Cagliari and Belgium at the University of Hasselt.
The Walking Adaptability Ladder Test (WALT), Foot Tap Test (FTT), Balance Recovery Scale, and Gait-Specific Attention Profile will be assessed twice, with a one-week interval, to evaluate test-retest reliability. The Timed 25-Foot Walk test, 6-Minute Walk Test, 2-Minute Stepping Test, Six-Spot Step Test, Heel Rise Test, Foot Tap Test, and Mini-BESTest will also be performed to assess walking and motor functions. Outcomes will be recorded using time- and observation-based methods, and inertial measurement unit will be used. Cognitive processing speed will be assessed using the Symbol Digit Modalities Test. Patient-reported outcomes will include perceived walking limitations (Multiple Sclerosis Walking Scale), fatigue (Modified Fatigue Impact Scale), balance confidence (Activities-specific Balance Confidence Scale), and fall history and concern about falling (Falls Efficacy Scale-International).
Statistical analyses will be performed to examine test-retest reliability, agreement, and measurement error of the WALT, FTT, Balance Recovery Scale, and Gait-Specific Attention Profile, to assess construct validity through associations with related clinical measures, and to compare performance between pwMS and healthy controls as well as across disability subgroups, using appropriate parametric or non-parametric methods with a predefined significance level (p\<0.05)
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 100 is close to 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.
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Participants will be recruited from the University of Leon, Ponferrada and Hospital Universitario de Ponferrada El Bierzo. A total of 50 persons with MS will be recruited and divided into two subgroups based on their disability level: EDSS 0-1.5 (n=25), EDSS 2.0-3.5 (n=25). 50 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 revised Mcdonald's criteria.
Age and sex matching is ensured within a five-year range per healthy control
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. The test involves a 10-meter agility ladder with 18 stepping targets that successively decrease in size. Participants are instructed to walk through the ladder, turn around a cone, and walk back through the ladder as accurately and as quickly as possible. After two familiarization trials, participants complete two single-run trials (one step per target) and two double-run trials (two steps per target), with two minutes of rest between each trial. All trials will be video recorded for the calculation of completion time (in seconds) and stepping errors, and additionally recorded using inertial movement sensors for outcomes of body displacement (trunk, lower back) and coordination.
Time frame: Day 1 and Day 2
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 and Day 2
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 and Day 2
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.
Time frame: Day 1 and Day 2
Symbol Digit Modalities Tets (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
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
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 2
Fall history and concern about falling
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. The Falls Efficacy Scale International (FES-I) will be used to evaluate concerns about falling.
Time frame: Day 2
The Activities-specific Balance Confidence (ABC) Scale
ABC will be 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 will be calculated, with higher scores reflecting greater balance confidence.
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. The test will be performed in forward and backward directions at both comfortable and fast speeds.
Time frame: Day 2
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. Total distance and distance covered per minute will be recorded using observational methods, in addition to inertial movement units (spatiotemporal parameters including speed, cadence, step length, step duration, double support phase, variability and asymmetry metrics).
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. Completion time in seconds will be used for analysis.
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 2
2-Minute Stepping Test (2MST)
It 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 derived from the sensors.
Time frame: Day 2
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, providing a comprehensive evaluation of balance control. The test is validated in various populations including individuals with neurological disorders.
Time frame: Day 1
Plan to share: Undecided
Started Nov 2025 (actual). Primary completion is estimated for Sep 2026, 9 months after the start.
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