Gait Adaptability in Persons With MS Having Mild Disability

NCT07580820 | Recruiting

• 1 other identifier: CME2024/032
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Multiple Sclerosis; Healthy Adults

Keywords

multiple sclerosis; gait; gait adaptability; balance

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  Day 1

Other Outcomes (16)

• Fall history

  Day 1

• The Modified Fatigue Impact Scale (MFIS)

  Day 1

• The Multiple Sclerosis Walking Scale (MSWS)

  Day 1

Study Arms (2)

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.

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

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.

You may qualify if:

• 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

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 (1)

REVAL Rehabilitation Research Center, University of Hasselt

Diepenbeek, 3500, Belgium

RECRUITING

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, PhD

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

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: May 12, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-03

Locations

BE (1)