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

NCT07505355 | Recruiting

• 1 other identifier: 25214 and 0338891
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 4

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1 and Day 2

Secondary Outcomes (2)

• Gait-Specific Attention Profile (GSAP)

  Day 1 and Day 2

• Balance Recovery Scale (BRC)

  Day 1 and Day 2

Other Outcomes (11)

• Symbol Digit Modalities Tets (SDMT)

  Day 1

• The Multiple Sclerosis Walking Scale (MSWS)

  Day 1

• The Modified Fatigue Impact Scale (MFIS)

  Day 2

Study Arms (2)

Multiple Sclerosis

People presenting with multiple sclerosis diagnosis according to the revised Mcdonald's criteria.

Healthy control group

Age and sex matching is ensured within a five-year range per healthy control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• confirmed diagnosis of definite MS,
• relapse free at least 30 days,
• Expanded Disability Status Scale (EDSS) score between 0 and 3.5

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (4)

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, Spain

RECRUITING

University of Leon

León, Ponferrada, Spain

RECRUITING

Related Links

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Zuhal Abasiyanik, PhD

CONTACT

+32(0)11 26 93 06; zuhal.abasiyanik@uhasselt.be

Peter Feys

CONTACT

+32(0)11 26 21 23; peter.feys@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: April 1, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

IT (1); ES (2); BE (1)