Gait Adaptability in Persons With MS Having Mild Disability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHasselt University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 2 trial groupsGroup A: Multiple sclerosis
Group B: Healthy controls
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 12
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.
Time frame
Day 13
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).
Time frame
Day 1Other outcomes
1
Fall history
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.
Time frame
Day 12
The Modified Fatigue Impact Scale (MFIS)
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.
Time frame
Day 13
The Multiple Sclerosis Walking Scale (MSWS)
MSWS includes 12 items and assesses perceived walking difficulties in daily life. Higher scores show higher MS-related walking impairment.
Time frame
Day 14
Symbol Digit Modalities Test (SDMT)
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.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov