- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505355
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
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zuhal Abasiyanik, PhD
- Phone Number: +32(0)11 26 93 06
- Email: zuhal.abasiyanik@uhasselt.be
Study Contact Backup
- Name: Peter Feys
- Phone Number: +32(0)11 26 21 23
- Email: peter.feys@uhasselt.be
Study Locations
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Diepenbeek, Belgium
- Recruiting
- REVAL Rehabilitation Research Center
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Contact:
- Peter Feys
- Phone Number: +32 11 29 21 23
- Email: peter.feys@uhasselt.be
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Cagliari, Italy
- Recruiting
- Laboratorio di Biomeccanica ed Ergonomia industriale Università degli Studi di Cagliari
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Contact:
- Massimiliano Pau
- Phone Number: +39 338 782 5240
- Email: massimiliano.pau@unica.it
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Ponferrada
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León, Ponferrada, Spain
- Recruiting
- Hospital Universitario de Ponferrada El Bierzo
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Contact:
- María Mercedes Reguera García, PhD
- Phone Number: (+34) 987 442000
- Email: mercedes.reguera@unileon.es
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León, Ponferrada, Spain
- Recruiting
- University of Leon
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Contact:
- María Mercedes Reguera García, PhD
- Phone Number: (+34) 987 442000
- Email: mercedes.reguera@unileon.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Multiple Sclerosis
People presenting with multiple sclerosis diagnosis according to the revised Mcdonald's criteria.
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Healthy control group
Age and sex matching is ensured within a five-year range per healthy control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Walking Adaptability Ladder Test (WALT)
Time Frame: Day 1 and Day 2
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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.
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Day 1 and Day 2
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Foot tap test (FTP)
Time Frame: Day 1 and Day 2
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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.
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Day 1 and Day 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Gait-Specific Attention Profile (GSAP)
Time Frame: Day 1 and Day 2
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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).
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Day 1 and Day 2
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Balance Recovery Scale (BRC)
Time Frame: Day 1 and Day 2
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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.
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Day 1 and Day 2
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Symbol Digit Modalities Tets (SDMT)
Time Frame: Day 1
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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.
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Day 1
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The Multiple Sclerosis Walking Scale (MSWS)
Time Frame: Day 1
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MSWS includes 12 items and assesses perceived walking difficulties in daily life.
Higher scores show higher MS-related walking impairment.
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Day 1
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The Modified Fatigue Impact Scale (MFIS)
Time Frame: Day 2
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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.
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Day 2
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Fall history and concern about falling
Time Frame: Day 2
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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.
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Day 2
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The Activities-specific Balance Confidence (ABC) Scale
Time Frame: Day 1
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ABC will be used to assess participants' self-perceived confidence in maintaining balance while performing various daily activities.
It includes 16 items; each rated from 0% (no confidence) to 100% (completely confident).
The average score will be calculated, with higher scores reflecting greater balance confidence.
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Day 1
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The Timed-25 Foot Walk (T25FW)
Time Frame: Day 2
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T25FW will be applied to evaluate the fastest walking speed.
The test will be carried out on a flat pathway, 7.62 m long.
The participants will be instructed to walk as quickly and safely as possible.
The average score of the two trials will be reported.
The test will be performed in forward and backward directions at both comfortable and fast speeds.
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Day 2
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The 6-Minute Walk Test (6MWT)
Time Frame: Day 1
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6MWT will be used to assess walking endurance.
Participants will be instructed to walk back and forth along a 30m, flat corridor for six minutes, covering as much distance as possible.
Total distance and distance covered per minute will be recorded using observational methods, in addition to inertial movement units (spatiotemporal parameters including speed, cadence, step length, step duration, double support phase, variability and asymmetry metrics).
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Day 1
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The Six-Spot Step Test (SSST)
Time Frame: Day 1
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SSST will be used to evaluate dynamic balance and coordinated lower limb function.
Participants will be asked to step as quickly as possible over six evenly spaced foam blocks arranged on the floor, following a standardized sequence.
Completion time in seconds will be used for analysis.
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Day 1
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The Heel Rise Test (HRT)
Time Frame: Day 2
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HRT evaluates the strength and endurance of the calf muscles.
Participants perform repeated single-leg heel raises (at least 5 cm) until fatigue or failure.
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Day 2
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2-Minute Stepping Test (2MST)
Time Frame: Day 2
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It measures aerobic endurance and lower limb function and serves as a practical and space-efficient alternative to walking tests.
Participants step in place for two minutes, raising their knees to a target height, and the number of full steps is recorded, frequency and amplitude will be derived from the sensors.
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Day 2
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MiniBest Test
Time Frame: Day 1
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The Mini-BESTest assesses dynamic balance across four domains: anticipatory postural adjustments, reactive postural control, sensory orientation, and gait.
It consists of 14 tasks scored on a 3-point scale, providing a comprehensive evaluation of balance control.
The test is validated in various populations including individuals with neurological disorders.
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Day 1
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25214 and 0338891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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