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Measurement Properties of the Walking Adaptability Ladder Test and Foot Tap Test in Multiple Sclerosis

Measurement Properties of the Walking Adaptability Ladder Test and Foot Tap Test in People With Multiple Sclerosis With Mild Disability

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07505355
Enrollment
100
Registered
2026-04-01
Start date
2025-11-10
Completion date
2026-12-01
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Controls Group - Age and Sex-matched, Multiple Sclerosis

Keywords

multiple sclerosis, walking, tapping, motor function, walking adaptability, falls

Brief summary

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.

Detailed description

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)

Interventions

None listed

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Walking Adaptability Ladder Test (WALT)Day 1 and Day 2WALT 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.
Foot tap test (FTP)Day 1 and Day 2Distal 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.

Secondary

MeasureTime frameDescription
Gait-Specific Attention Profile (GSAP)Day 1 and Day 2GSAP 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).
Balance Recovery Scale (BRC)Day 1 and Day 2BRC 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.

Countries

Belgium, Italy, Spain

Contacts

CONTACTZuhal Abasiyanik, PhD
zuhal.abasiyanik@uhasselt.be+32(0)11 26 93 06
CONTACTPeter Feys
peter.feys@uhasselt.be+32(0)11 26 21 23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026