Multiple SclerosisNCT07580820
Gait Adaptability in Persons With MS Having Mild Disability
An observational study of Multiple Sclerosis and Healthy Adults, run by Hasselt University at 1 site in Belgium.
Trial summary
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that frequently leads to walking impairment, balance deficits, fatigue, cognitive difficulties, and an increased risk of falls. 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 Adults
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Dec 2025to 20 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: A total of 16 persons with MS will be recruited. 16 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
- Age between 18-65 years,
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
REVAL Rehabilitation Research Center, University of Hasselt
Diepenbeek, 3500
Peter Feys, +32 11 29 21 23, peter.feys@uhasselt.be
About this study
Official title: Multidimensional Assessment of Gait Adaptability in Persons Multiple Sclerosis With no to Mild Disability
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that frequently leads to walking impairment, balance deficits, fatigue, cognitive difficulties, and an increased risk of falls. Importantly, these problems can already be present in the early stages of the disease and may not be adequately captured by standard clinical walking tests, which primarily assess speed or distance. Such tests are often insufficient to reflect the complexity of real-life walking, which requires continuous adaptation to environmental challenges, and attention to internal and external stimuli.
Gait adaptability, the ability to modify walking patterns in response to changing and unpredictable demands such as obstacles or sudden perturbations, is critical for safe mobility and fall prevention. Both proactive (anticipatory) and reactive (feedback-driven) gait adaptations are essential for maintaining balance and functional independence. However, gait adaptability and its underlying neural mechanisms remain insufficiently understood in people with MS.
Read more
This study aims to provide a comprehensive assessment of gait adaptability in people with MS by evaluating both proactive and reactive gait adaptations using objective gait measurements and cortical activity recordings. The findings may contribute to the development of more sensitive outcome measures and inform targeted rehabilitation strategies that better reflect real-life mobility demands.
Primary aims:
- To investigate the behavioral measures and neural correlates of reactive and proactive gait adaptability in pwMS compared to HC
Secondary aims:
- To investigate factors related to gait adaptability
- To investigate changes in gait adaptability during prolonged walking conditions
Read the detailed description
A total of 16 persons with MS will be recruited. In addition, 16 healthy controls, matched for age and sex, will be recruited for comparison. Participants will be recruited by researchers from the REVAL Research Center at Hasselt University using the REVAL website and social media platforms, as well as those of relevant organizations. Healthy control participants will be recruited via flyers and social media, with age- and sex-matching applied using a 5-year age range.
The study consists of a single testing session. Outcomes will be recorded using time- and observation-based methods, and movement sensors will be used for motor performance tests, including the Timed 25-Foot Walk Test, Foot Tap Test, Heel Rise Test, 2-Minute Stepping Test, Six-Spot Step Test, and the 6-Minute Walk Test. Self-report questionnaires, including the Falls Efficacy Scale-International, Multiple Sclerosis Walking Scale, Modified Fatigue Impact Scale, Activities-specific Balance Confidence Scale, Gait-Specific Attention Profile, and Balance Recovery Confidence Scale, will be administered. The Mini-BESTest and cognitive tests, including SDMT and BVMT-R will be performed to assess balance and cognitive functions.
Proactive gait adaptability will be assessed using an overground gait adaptability test (i.e., the Walking Adaptability Ladder Test). Participants will walk along a 10-meter walkway with stepping targets indicated by bars and rows that progressively decrease in size. They will be instructed to adapt their steps to the targets while walking at a fast pace. Three conditions will be performed, each lasting 20 seconds and repeated five times, with 15 seconds of rest between trials during which participants will stand upright. The conditions include walking with one step per target, walking with two steps per target, and a control walking condition consisting of usual walking over the 10-meter walkway at the fastest safe walking speed without running. Reactive gait adaptability will be evaluated using an instrumented augmented reality system (Computer Assisted Rehabilitation Environment Extended [CAREN]; Motekforce Link, The Netherlands). Twelve unannounced repetitive perturbations will be applied. The CAREN system is designed for biomechanical analysis of human movement and utilizes high-resolution recordings via a 3D motion capture system equipped with 18 Vicon cameras (Vicon Motion Systems, Oxford, UK). The dual-belt treadmill incorporates two embedded force plates and allows for self-paced speed adjustments. Clinically relevant spatiotemporal gait parameters and gait stability measures will be processed. Cortical brain hemodynamics will be assessed using functional near-infrared spectroscopy (fNIRS; NIRSport™, NIRx, Germany), composed of 16 sources and 16 detectors. The fNIRS cap will be worn during both proactive and reactive gait adaptability conditions.
- Conditions
- Multiple Sclerosis, Healthy Adults
- Keywords
- multiple sclerosis, gait, gait adaptability, balance
- 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 2017 revisions of the Mcdonald's criteria. | |
| Healthy controls | Inclusion criteria for healthy controls: inclusion of age between 18 and 65 years old, sex- and age-matched on a group level. |
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. All trials will be video recorded for the calculation of completion time (in seconds) and stepping errors and additionally recorded using inertial movement sensors.
Measured: Day 1
Reactive gait adaptations
Instrumented reactive gait adaptability will be evaluated using the safe augmented reality system (The Computer Assisted Rehabilitation Environment Extended- CAREN; Motekforce Link, NL). 12 unannounced repetitive perturbations will be applied. Margin of stability, center of mass velocity and range, step width, step length, and knee kinematics will be recorded by the Vicon Motion System (VICON, Oxford, UK). Adaptation across perturbations will be assessed by examining changes in these parameters over successive trials.
Measured: Day 1
Relative concentration of oxyhemoglobin and deoxyhemoglobin
The cortical brain hemodynamics during walking will be assessed through fNIRS (NIRSport TM, NIRX, Germany) composed of 16 sources and 16 detectors (wavelengths 760- 850nm). The hemodynamic signals will be recorded at a sampling rate of 10.25 Hz. A standard cap will be placed over each participant's scalp, and sources and detectors will be positioned on the measuring cap according to the 10-20 International system. The spatial distribution of the optodes on the cap will be chosen to create channels (i.e., source-detector pairs) with standard inter-optode distances of a maximum 3 cm. Optodes will be placed over both hemispheres to collect hemodynamic activity in bilateral PFC (Broadman areas 9,46 and 11), PMC (Broadman area 6), SMA (Broadman area 6), and Posterior parietal cortex (PPC-BA5,7).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start5 Dec 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion20 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
- 32 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
- NCT07580820
- Sponsor's protocol ID
- CME2024/032
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of Gait Adaptability in Persons Multiple Sclerosis With no to Mild Disability
- ClinicalTrials.gov ID
- NCT07580820
- Acronym / sponsor ID
- CME2024/032
- Conditions
- Multiple Sclerosis, Healthy Adults
- Keywords
- multiple sclerosis, gait, gait adaptability, balance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 12 May 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.
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that frequently leads to walking impairment, balance deficits, fatigue, cognitive difficulties, and an increased risk of falls. Importantly, these problems can already be present in the early stages of the disease and may not be adequately captured by standard clinical walking tests, which primarily assess speed or distance. Such tests are often insufficient to reflect the complexity of real-life walking, which requires continuous adaptation to environmental challenges, and attention to internal and external stimuli.
Gait adaptability, the ability to modify walking patterns in response to changing and unpredictable demands such as obstacles or sudden perturbations, is critical for safe mobility and fall prevention. Both proactive (anticipatory) and reactive (feedback-driven) gait adaptations are essential for maintaining balance and functional independence. However, gait adaptability and its underlying neural mechanisms remain insufficiently understood in people with MS.
This study aims to provide a comprehensive assessment of gait adaptability in people with MS by evaluating both proactive and reactive gait adaptations using objective gait measurements and cortical activity recordings. The findings may contribute to the development of more sensitive outcome measures and inform targeted rehabilitation strategies that better reflect real-life mobility demands.
Primary aims:
- To investigate the behavioral measures and neural correlates of reactive and proactive gait adaptability in pwMS compared to HC
Secondary aims:
- To investigate factors related to gait adaptability
- To investigate changes in gait adaptability during prolonged walking conditions
Detailed description
A total of 16 persons with MS will be recruited. In addition, 16 healthy controls, matched for age and sex, will be recruited for comparison. Participants will be recruited by researchers from the REVAL Research Center at Hasselt University using the REVAL website and social media platforms, as well as those of relevant organizations. Healthy control participants will be recruited via flyers and social media, with age- and sex-matching applied using a 5-year age range.
The study consists of a single testing session. Outcomes will be recorded using time- and observation-based methods, and movement sensors will be used for motor performance tests, including the Timed 25-Foot Walk Test, Foot Tap Test, Heel Rise Test, 2-Minute Stepping Test, Six-Spot Step Test, and the 6-Minute Walk Test. Self-report questionnaires, including the Falls Efficacy Scale-International, Multiple Sclerosis Walking Scale, Modified Fatigue Impact Scale, Activities-specific Balance Confidence Scale, Gait-Specific Attention Profile, and Balance Recovery Confidence Scale, will be administered. The Mini-BESTest and cognitive tests, including SDMT and BVMT-R will be performed to assess balance and cognitive functions.
Proactive gait adaptability will be assessed using an overground gait adaptability test (i.e., the Walking Adaptability Ladder Test). Participants will walk along a 10-meter walkway with stepping targets indicated by bars and rows that progressively decrease in size. They will be instructed to adapt their steps to the targets while walking at a fast pace. Three conditions will be performed, each lasting 20 seconds and repeated five times, with 15 seconds of rest between trials during which participants will stand upright. The conditions include walking with one step per target, walking with two steps per target, and a control walking condition consisting of usual walking over the 10-meter walkway at the fastest safe walking speed without running. Reactive gait adaptability will be evaluated using an instrumented augmented reality system (Computer Assisted Rehabilitation Environment Extended [CAREN]; Motekforce Link, The Netherlands). Twelve unannounced repetitive perturbations will be applied. The CAREN system is designed for biomechanical analysis of human movement and utilizes high-resolution recordings via a 3D motion capture system equipped with 18 Vicon cameras (Vicon Motion Systems, Oxford, UK). The dual-belt treadmill incorporates two embedded force plates and allows for self-paced speed adjustments. Clinically relevant spatiotemporal gait parameters and gait stability measures will be processed. Cortical brain hemodynamics will be assessed using functional near-infrared spectroscopy (fNIRS; NIRSport™, NIRx, Germany), composed of 16 sources and 16 detectors. The fNIRS cap will be worn during both proactive and reactive gait adaptability conditions.
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 2017 revisions of the Mcdonald's criteria. |
| Healthy controls | – | –Inclusion criteria for healthy controls: inclusion of age between 18 and 65 years old, sex- and age-matched on a group level. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 16 persons with MS will be recruited. 16 healthy controls, matched for age (considering a 5-year range per subject) and sex, will be recruited for comparison.
Key inclusion criteria (4 listed)
- Age between 18-65 years,
- 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
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. All trials will be video recorded for the calculation of completion time (in seconds) and stepping errors and additionally recorded using inertial movement sensors.
Reactive gait adaptations
Time frame: Day 1
Instrumented reactive gait adaptability will be evaluated using the safe augmented reality system (The Computer Assisted Rehabilitation Environment Extended- CAREN; Motekforce Link, NL). 12 unannounced repetitive perturbations will be applied. Margin of stability, center of mass velocity and range, step width, step length, and knee kinematics will be recorded by the Vicon Motion System (VICON, Oxford, UK). Adaptation across perturbations will be assessed by examining changes in these parameters over successive trials.
Relative concentration of oxyhemoglobin and deoxyhemoglobin
Time frame: Day 1
The cortical brain hemodynamics during walking will be assessed through fNIRS (NIRSport TM, NIRX, Germany) composed of 16 sources and 16 detectors (wavelengths 760- 850nm). The hemodynamic signals will be recorded at a sampling rate of 10.25 Hz. A standard cap will be placed over each participant's scalp, and sources and detectors will be positioned on the measuring cap according to the 10-20 International system. The spatial distribution of the optodes on the cap will be chosen to create channels (i.e., source-detector pairs) with standard inter-optode distances of a maximum 3 cm. Optodes will be placed over both hemispheres to collect hemodynamic activity in bilateral PFC (Broadman areas 9,46 and 11), PMC (Broadman area 6), SMA (Broadman area 6), and Posterior parietal cortex (PPC-BA5,7).
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 12 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Healthy Adults, run by Hasselt University at 1 site in Belgium.
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 4 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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). The study lists 3 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 12 May 2026.