Measurement Properties of the Walking Adaptability Ladder Test and Foot Tap Test in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHasselt University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
confirmed diagnosis of definite MS,
relapse free at least 30 days,
Expanded Disability Status Scale (EDSS) score between 0 and 3.5
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Multiple Sclerosis
Group B: Healthy control group
Trial outcomes
Primary outcomes
1
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 22
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 2Secondary outcomes
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 and Day 22
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 2Other outcomes
1
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 12
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 13
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 24
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 2Sponsors and contacts
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Source ClinicalTrials.gov