Multiple SclerosisNCT07505355
Measurement Properties of the Walking Adaptability Ladder Test and Foot Tap Test in Multiple Sclerosis
An observational study of Multiple Sclerosis and Healthy Controls Group - Age and Sex-matched, run by Hasselt University at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy Controls Group - Age and Sex-matched
- How many people
- 100 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Nov 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- confirmed diagnosis of definite MS,
- relapse free at least 30 days,
- Expanded Disability Status Scale (EDSS) score between 0 and 3.5
Who cannot join
- 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 locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Ponferrada El Bierzo
León, Ponferrada
María Mercedes Reguera García, PhD, (+34) 987 442000, mercedes.reguera@unileon.es
- Recruiting
University of Leon
León, Ponferrada
María Mercedes Reguera García, PhD, (+34) 987 442000, mercedes.reguera@unileon.es
Belgium1 site, 1 recruiting
- Recruiting
REVAL Rehabilitation Research Center
Diepenbeek
Peter Feys, +32 11 29 21 23, peter.feys@uhasselt.be
Italy1 site, 1 recruiting
- Recruiting
Laboratorio di Biomeccanica ed Ergonomia industriale Università degli Studi di Cagliari
Cagliari
Massimiliano Pau, +39 338 782 5240, massimiliano.pau@unica.it
About this study
Official title: Measurement Properties of the Walking Adaptability Ladder Test and Foot Tap Test in People With Multiple Sclerosis With Mild Disability
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.
Read the 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)
- Keywords
- multiple sclerosis, walking, tapping, motor function, walking adaptability, falls
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 and Day 2
Secondary outcomes (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).
Measured: 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.
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start10 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505355
- Sponsor's protocol ID
- 25214 and 0338891
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Properties of the Walking Adaptability Ladder Test and Foot Tap Test in People With Multiple Sclerosis With Mild Disability
- ClinicalTrials.gov ID
- NCT07505355
- Acronym / sponsor ID
- 25214 and 0338891
- Keywords
- multiple sclerosis, walking, tapping, motor function, walking adaptability, falls
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- confirmed diagnosis of definite MS,
- relapse free at least 30 days,
- Expanded Disability Status Scale (EDSS) score between 0 and 3.5
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Walking Adaptability Ladder Test (WALT)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Gait-Specific Attention Profile (GSAP)
Time frame: Day 1 and Day 2
Balance Recovery Scale (BRC)
Time frame: Day 1 and Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Healthy Controls Group - Age and Sex-matched, run by Hasselt University at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuhal Abasiyanik, PhD (+32(0)11 26 93 06, zuhal.abasiyanik@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Adaptability Ladder Test (WALT) (time frame: Day 1 and Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.