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Recruiting Observational

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

NCT07505355 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-11-10
Last updated
2026-04-01

Condition(s) studied

Multiple SclerosisHealthy Controls Group - Age and Sex-matched

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Walking Adaptability Ladder Test (WALT) — Day 1 and Day 2
    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.
  • Foot tap test (FTP) — Day 1 and Day 2
    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.

Trial sites (4)

FacilityCityRegionStatus
REVAL Rehabilitation Research Center Diepenbeek Belgium Recruiting
Laboratorio di Biomeccanica ed Ergonomia industriale Università degli Studi di Cagliari Cagliari Italy Recruiting
Hospital Universitario de Ponferrada El Bierzo León Ponferrada Recruiting
University of Leon León Ponferrada Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07505355 on ClinicalTrials.gov ↗ ← All trials in Italy