Multiple SclerosisNCT07175792
Accuracy of Motor Performance Perception in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Hasselt University at 3 sites in Belgium.
Trial summary
The aim of this study is to characterize perceptive abilities in PwMS compared to controls when performing prolonged functional tasks such as walking and repeated standing from a seated position. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 72 participants
- Where
- 3 sitesBelgium
- Study dates
- 9 Dec 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 44 PwMS and 44 healthy controls will be recruited from the Flemish MS rehabilitation centers in Melsbroek (NMSC) and Pelt (Noorderhart RMSC), and as well from the REVAL research center in UHasselt. No economical compensation will be provided. We will search age and sex-matching healthy controls, considering a 5-year range per subject. After giving informed consent, demographics of age and gender, height and weight, years of education, as well as MS-related information such as EDSS, type of MS, use of assistive device for walking in daily life, and year of diagnosis, will be collected and provided by the centers or via self-report. The participants will be instructed to keep their normal routine but to avoid extraneous physical activity at least 24 hours before the data collection session.
Who may be able to join
- age between 18 and 70 years old
- ability to walk for 6 minutes without rest and without the need of a walking aid
- ability to repeatedly perform the sit to stand transitions on a standard chair (43cm seat height) without hand support
- For People with Multiple Sclerosis group
- a diagnosis of MS (2017 revisions of the McDonalds criteria)
- no disease relapses >1 month preceding the start of the study
Who cannot join
- cognitive impairment hindering understanding of study instructions
- ongoing or suspected pregnancy
- musculoskeletal disorders in the lower limbs
- cardiovascular red flags for exercise (screened with Physical Activity Readines Questionnaire)
- other diagnosis for neurological or metabolic disease limiting the full execution of the tests
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
REVAL
Diepenbeek, Belgium, 3590
Noorderhart Revalidatie & MS
Overpelt, Belgium, 3900
Nationaal MS-Centrum Melsbroek
Steenokkerzeel, Belgium, 1820
About this study
Official title: Assessment of Perceptive Accuracy for Motor Performance in Persons With Multiple Sclerosis
The aim of this study is to characterize perceptive abilities in PwMS compared to controls when performing prolonged functional tasks such as walking and repeated standing from a seated position.
This study proposes primary and secondary research questions which will be tested in the context of two different newly designed experimental tasks and will be performed in maximum three days.
The self-reported beliefs over perceptive abilities and the performance in the experimental perceptive tasks will be compared between persons with multiple sclerosis and an equally sized group of age and gender matched healthy controls. The results of this study may uncover specific deficits in the MS population and will help in defining subgroups of patients with weaker perceptive capacities to gauge their motor performance and therefore in need for tailored interventions additional to the standard practice.
Read the detailed description
For all work packages, the following information will be recorded from all participants in the first day: demographic data and PROMs of physical activity level [Godin Leisure-Time Exercise questionnaire], sleep quality [Pittsburgh Sleep Quality Index], self-efficacy [General and MS-specific Self-Efficacy scales], affectivity [Positive and Negative Affect Schedule], anxiety and depression [Hospital Anxiety and Depression Scale], habitual symptoms and fatigue [Checklist for Symptoms in Daily life, Brief Pain Inventory, Fatigue Scale for Motor and Cognitive Functions and Modified Fatigue Impact Scale], body and mobility perception [Multidimensional Assessment of Interoceptive Awareness (MAIA-2), Interoceptive Sensitivity and Attention Questionnaire (ISAQ), Postural Awareness Scale (PAS), Multiple Sclerosis Walking Scales, Falls Efficacy Scale] are recorded via secured digital surveys (CASTOR© Electronic Data Capture system). Symbol Digit Modalities Test (SDMT) for processing speed; Brief Visuospatial Memory Test (BVMT) for memory skills; Dual Joint Position Test (DJPT) for proprioception Timed 25-Foot Walk test (T25FW) for maximal walking speed; Test for the Sensory Interaction of Balance (for postural control; 6-Minutes Walking Test (6MWT, walking as far but safe during 6') and 30 seconds Chair Stand Test (30CST, completing as many STSs in 30 seconds) for specific walking and STS performance. IMUs are applied (APDM©, see below) and subjective state fatigue is measured before and after motor performance tasks using a Visual Analogue Scale (VAS, scoring from 0 to 10).
Work package 1a -Protocol: Participants will be familiarized with task-specific perceptual reporting methods. Standardized instructions are formulated in a neutral way to not bias participants' attention toward their symptoms. They will be instructed to report the time-points of perceived changes ("as soon as you perceive it"), either positive or negative, in quantitative or qualitative aspects of their motor performance: the speed or the smoothness of their self-motion. It is explained to the participants as 'a movement that happens in a continual fashion, without any interruptions'. To collect reports we designed a light portable haptic device fitting in the hand (shaped in a similar fashion as the Jamar hand-dynamometer®) and connected via Bluetooth® to a peak-detection Matlab© algorithm. Reports were given by a squeeze. To remove the signal noise produced by involuntary hand-grip forces, the threshold sensitivity of the sensor (i.e., minimum to save a report) will be set at 25% of the maximal hand-grip strength of the participant.
The first task involves a 6MWT at maximal walking speed in silence (eg. no information on time-on-test or verbal encouragements), while instructed to perceive fluctuations in either speed either smoothness (2 walking sessions, counterbalanced order) fluctuations and, as soon as they perceive a performance change, squeeze the sensor in the handheld device. The second task consists on repeated STS transitions: participants perform STSs at a fixed pace (one every ten seconds for six minutes), each one attempting to maximize speed, from a chair with normalized seat-height (lower leg length). Participants will use the handheld force sensor to indicate when variations are perceived during the task, comparing speed/smoothness (2 STS sessions, counterbalanced order) of consecutive STS transitions. Motor performance in the 2 tasks will be recorded with wearable sensors: 6 APDM© inertial motion units (2 over the dorsal part of the feet, 2 on the lower legs, 1 anterior to the sternum and 1 posterior to the fourth lumbar vertebra). The recordings allow for an objective comparison between reported and actual performance variations. Fatigue perception will be assessed before and after each session using the VAS. A brief interview will follow, asking participants to rate their confidence for having been accurate in detecting performance variations (on a scale from to 100) and to describe their own strategy: the sensory cues they relied on, for their reports.
-Work package 1b. "Imposed motor performance" WP1b assesses perceptive awareness for externally-imposed motor performance variations. After assessing perceptive sensitivity for performance variations in self-paced scenarios, we now focus on the quantification of subjects' perceptive accuracy using a real-time verbal reporting approach. Like in WP1a, we will use 2 tasks, walking and STS, with order counterbalanced at group level.
Protocol Walking task - Treadmill Participants will familiarize during a 10-minute supervised treadmill session with the moving belt, safety bars, and general usability. To determine a personalized speed range, participants will start walking at 50% of their maximal walking speed, calculated in their 6MWT overground performance as the highest 15-second moving average. They need to confirm if that is their comfortable treadmill walking speed. If not, adjustments will be made. Participants will see a vertical visual scale in front of them to indicate perceived variations: verbal descriptors will indicate walking speed, with 0% representing comfort and +100% representing maximal walking speed. Afterwards, they will be instructed to adapt their gait to continuous belt acceleration toward their maximal walking speed. This is as familiarization with their personalized range of speed: they will be informed about every 10th step on the VAS (0-100), experiencing how it feels to walk at those speed levels.
Participants will walk on a treadmill with the speed systematically increasing and decreasing within the predefined individual range. The task lasts 6 minutes, starting with 1 minute at the self-selected comfortable speed. Then, speed increases for all participants by 1.5 km/h in 15 steps (0.1 km/h each) over 150 seconds, never exceeding the participant's max walking speed. After a brief plateau, imposed speed is decreasing in the same manner over 150 seconds. Speed changes occur at randomly timed intervals of 5-15 seconds each while verbal reports are prompted and recorded every 10 seconds. The choice of a fixed range of imposed speed, with identical magnitude and timing of speed increments, was defined after piloting the experiment with PwMS and HC to ensure a standardized comparison of absolute speed changes between groups. In order to not alter the participants' gait pattern on the treadmill, we avoided the use of a safety harness, what was also not needed for PwMS with mild impairment. Also, to remove external cues as treadmill sound, we ask participants to wear noise cancelling headphones playing white noise.
Protocol STS task - Chair for Interoceptive Assessment n.0 (CIA0) To impose STS difficulty variations, we mounted a standard chair on a hydraulic system that allows real-time seat height adjustments while an infrared optical sensor continuously measures the distance from the ground, ensuring precise control. This setup enables dynamic and personalized STS assessments and training and we believe it may open new possibilities for rehabilitation and tele-rehabilitation. The baseline seat height will be individually normalized to each participant's lower leg length (measured as the distance from the ground to the inferior margin of the patella). To define a personalized range of imposed difficulty, the seat height will be adjusted between ±20% of this baseline, with the lowest height representing the most challenging condition. Participants will familiarize themselves with each STS level by performing transitions at different seat heights while being informed of their corresponding position on a vertical visual scale (every 10th step, ranging from 0% comfort to -100% minimal seat height).
Participants will perform STS transitions at a fixed pace and completing one repetition every 10 seconds, but always starting from a standing position, sitting down and immediately after shifting their weight on the chair stand up as quickly as possible. No specific instructions are given about the stand-to-sit phase, considered as part of the perceptive strategy. To ensure they rely solely on movement perception, they look straight ahead not receiving any feedback on seat height changes. During the stance phase in between STS repetitions, the seat height will be modified starting from the baseline (comfortable seat-height= lower leg length + its 20%) with fixed decrements (5% of lower leg length) but with randomized number of repetitions (0, 1 or 2) in between variations in seat height. The seat-height lowering will continue down to the personalized lowest seat-height (not having safety constraints in this case), stabilizing on that value before increasing toward the baseline height. After each repetition, participants will verbally report the number corresponding to their perceived difficulty level based on the pre-established scale.
- Conditions
- Multiple Sclerosis
- Keywords
- Motor Performance, Task-specific, Perception, Multiple Sclerosis, Walking, Sit-to-stand, Inteoception
- 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 |
|---|---|---|
| Subjects with Multiple Sclerosis | Inclusion criteria: Age between 18 and 70 years old; a diagnosis of MS (2017 revisions of the McDonalds criteria); ability to walk for 6 minutes without rest and without the need of a walking aid; ability to repeatedly perform the sit to stand transitions on a standard chair (43cm seat height) without hand support. Additionally, no relapses >1 month preceding the start of the study. Exclusion criteria: cognitive impairment hindering understanding of study instructions, pregnancy, and musculoskeletal disorders in the lower limbs (not related to MS), cardiovascular red flags for exercise (screened with Physical Activity Readines Questionnaire), other diagnosis for neurological or metabolic disease limiting the full execution of the tests (eg. peripheral neuropathy altering the foot plantar sensibility). | |
| Healthy Controls | Age and sex matching is ensured within a five-year range per Healthy Contol. Exclusion criteria: cognitive impairment hindering understanding of study instructions, pregnancy, and musculoskeletal disorders in the lower limbs, cardiovascular red flags for exercise (screened with Physical Activity Readines Questionnaire), other diagnosis for neurological or metabolic disease limiting the full execution of the tests (eg. peripheral neuropathy altering the foot plantar sensibility). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptive Sensitivity
Ratio between participants' reporting frequency and actual variability in motor performance (e.g., gait and sit-to-stand [STS]), referred to as the 'Detection-rate.' Number of pinches is divided by the Coefficient of Variability (in %, of speed or smoothness parameter) in the studied time-window.
Measured: Day 1
Detection Accuracy
Accuracy of detecting naturally occurring variations in self-paced gait and sit-to-stand (STS) performance. Objective change points (events) in speed/smoothness are identified using peak detection algorithms with a predefined threshold to extract only perceptually meaningful speed/smoothness fluctuations. Participants indicate perceived changes using a pinch gesture. A response is classified as correct if it occurs within a ±2-second window of a detected event. Responses outside this window or unmatched with any event are incorrect. Perceptive accuracy is modeled as a binary variable (correct/incorrect) and analyzed using mixed-effects logistic regression to account for repeated measures within subjects.
Measured: Day 1
Correspondence Accuracy
Intra-subject correlation between perceived and actual imposed variations in walking speed or seat height, across different difficulty levels.
Pearson correlations will study the linear relationship between the exercise difficulty and the reported difficulty. A Fisher Z transformation is carried out on all correlations before further analysis (group level comparisons across participants).
-Detailed Picture of Each Phase: Average exercise difficulty and reported difficulty are calculated for every 30 s (or 3 STS repetitions). Multiple mixed model analyses are performed on the phases separately, with exercise difficulty and reported difficulty as dependent variables in separate analyses.
Group (patient versus controls) and time are used as independent variables in all analyses. To control for potential baseline differences in any of the outcome variables exercise and reported difficulty in the last 30 s of the baseline phase are added as covariates in the analyses.
Measured: Day 2
Secondary outcomes (6)
Confidence Rating
A short structured interview follows the experimental tasks of Day 1 and Day 2, including the following question: "On a scale from 0 to 100, how certain are you that you have been precise/accurate in detecting ongoing variations in your performance? Please mark your confidence level on the presented visual scale". Higher values representing higher confidence (subjective beliefs on their perceptive accuracy).
Measured: Day 1 and 2
Perceptive Awareness
Degree of correspondence between participants' subjective confidence ratings and actual perceptual accuracy in detecting motor performance changes.
To obtain a crude measure of perceptive awareness, we use two complementary approaches. First, we calculate a confidence-accuracy gap for each participant by subtracting their objective task accuracy from their retrospective confidence rating (in %). Positive values indicate overconfidence, while negative values indicate underconfidence. Second, to assess metacognitive awareness at the group level, we computed the correlation between participants' confidence ratings and their task accuracy. This group-level analysis provides an estimate of whether individuals who were more accurate also tended to be more confident or if there are specific trends differing between groups.
Measured: Day 1 and 2
Interoceptive Sensibility
Participants' self-reported (subjective) beliefs about their interoceptive abilities is assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA-2). This scale is a self-report questionnaire to measure multiple dimensions of interoception: 8 different subscales, each averaging the items scores ranging from 0-5 (higher scores representing higher reported interoceptive abilities).
Measured: Day 1
Proprioceptive Sensibility
Self-reported awareness of body posture consisting of 12 items, and with a total score ranging from 12 to 84, with higher scores representing higher reported postural awareness.
Measured: Day 1
Interoceptive Sensitivity and Attention Questionnaire (ISAQ)
This scale is a self-report measure assessing sensitivity and attention to interoceptive signals. It is divided in 3 subscales: -Sensitivity to neutral bodily sensations (items 1, 3, 5, 8, 9, 11, 13, 15, 17) -Attention to unpleasant bodily sensations (items 6, 10, 14, 16) -Difficulty disengaging from unpleasant bodily sensations (items 2, 4, 7, 12 all reverse scored before summing). Total score ranges from 17-85 but for this study only the first 2 subscales will be considered: 'Sensitivity to neutral bodily sensations' (score range 9-45) and 'Attention to unpleasant bodily sensations' (score range 4-20) with higher scores representing higher reported sensitivity or attention.
Measured: Day 1
6 minutes walking test
The total distance and the distance walked, in meters, minute-by-minute will be recorded during the 6-minutes walking test.
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 posted16 Sep 2025
- Study start9 Dec 2024
- Primary completion16 Oct 2025
- Study completion30 Jun 2026
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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175792
- Sponsor's protocol ID
- B1152024000009
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Perceptive Accuracy for Motor Performance in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07175792
- Acronym / sponsor ID
- B1152024000009
- Conditions
- Multiple Sclerosis
- Keywords
- Motor Performance, Task-specific, Perception, Multiple Sclerosis, Walking, Sit-to-stand, Inteoception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 16 Sep 2025 (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.
The aim of this study is to characterize perceptive abilities in PwMS compared to controls when performing prolonged functional tasks such as walking and repeated standing from a seated position.
This study proposes primary and secondary research questions which will be tested in the context of two different newly designed experimental tasks and will be performed in maximum three days.
The self-reported beliefs over perceptive abilities and the performance in the experimental perceptive tasks will be compared between persons with multiple sclerosis and an equally sized group of age and gender matched healthy controls. The results of this study may uncover specific deficits in the MS population and will help in defining subgroups of patients with weaker perceptive capacities to gauge their motor performance and therefore in need for tailored interventions additional to the standard practice.
Detailed description
For all work packages, the following information will be recorded from all participants in the first day: demographic data and PROMs of physical activity level [Godin Leisure-Time Exercise questionnaire], sleep quality [Pittsburgh Sleep Quality Index], self-efficacy [General and MS-specific Self-Efficacy scales], affectivity [Positive and Negative Affect Schedule], anxiety and depression [Hospital Anxiety and Depression Scale], habitual symptoms and fatigue [Checklist for Symptoms in Daily life, Brief Pain Inventory, Fatigue Scale for Motor and Cognitive Functions and Modified Fatigue Impact Scale], body and mobility perception [Multidimensional Assessment of Interoceptive Awareness (MAIA-2), Interoceptive Sensitivity and Attention Questionnaire (ISAQ), Postural Awareness Scale (PAS), Multiple Sclerosis Walking Scales, Falls Efficacy Scale] are recorded via secured digital surveys (CASTOR© Electronic Data Capture system). Symbol Digit Modalities Test (SDMT) for processing speed; Brief Visuospatial Memory Test (BVMT) for memory skills; Dual Joint Position Test (DJPT) for proprioception Timed 25-Foot Walk test (T25FW) for maximal walking speed; Test for the Sensory Interaction of Balance (for postural control; 6-Minutes Walking Test (6MWT, walking as far but safe during 6') and 30 seconds Chair Stand Test (30CST, completing as many STSs in 30 seconds) for specific walking and STS performance. IMUs are applied (APDM©, see below) and subjective state fatigue is measured before and after motor performance tasks using a Visual Analogue Scale (VAS, scoring from 0 to 10).
Work package 1a -Protocol: Participants will be familiarized with task-specific perceptual reporting methods. Standardized instructions are formulated in a neutral way to not bias participants' attention toward their symptoms. They will be instructed to report the time-points of perceived changes ("as soon as you perceive it"), either positive or negative, in quantitative or qualitative aspects of their motor performance: the speed or the smoothness of their self-motion. It is explained to the participants as 'a movement that happens in a continual fashion, without any interruptions'. To collect reports we designed a light portable haptic device fitting in the hand (shaped in a similar fashion as the Jamar hand-dynamometer®) and connected via Bluetooth® to a peak-detection Matlab© algorithm. Reports were given by a squeeze. To remove the signal noise produced by involuntary hand-grip forces, the threshold sensitivity of the sensor (i.e., minimum to save a report) will be set at 25% of the maximal hand-grip strength of the participant.
The first task involves a 6MWT at maximal walking speed in silence (eg. no information on time-on-test or verbal encouragements), while instructed to perceive fluctuations in either speed either smoothness (2 walking sessions, counterbalanced order) fluctuations and, as soon as they perceive a performance change, squeeze the sensor in the handheld device. The second task consists on repeated STS transitions: participants perform STSs at a fixed pace (one every ten seconds for six minutes), each one attempting to maximize speed, from a chair with normalized seat-height (lower leg length). Participants will use the handheld force sensor to indicate when variations are perceived during the task, comparing speed/smoothness (2 STS sessions, counterbalanced order) of consecutive STS transitions. Motor performance in the 2 tasks will be recorded with wearable sensors: 6 APDM© inertial motion units (2 over the dorsal part of the feet, 2 on the lower legs, 1 anterior to the sternum and 1 posterior to the fourth lumbar vertebra). The recordings allow for an objective comparison between reported and actual performance variations. Fatigue perception will be assessed before and after each session using the VAS. A brief interview will follow, asking participants to rate their confidence for having been accurate in detecting performance variations (on a scale from to 100) and to describe their own strategy: the sensory cues they relied on, for their reports.
-Work package 1b. "Imposed motor performance" WP1b assesses perceptive awareness for externally-imposed motor performance variations. After assessing perceptive sensitivity for performance variations in self-paced scenarios, we now focus on the quantification of subjects' perceptive accuracy using a real-time verbal reporting approach. Like in WP1a, we will use 2 tasks, walking and STS, with order counterbalanced at group level.
Protocol Walking task - Treadmill Participants will familiarize during a 10-minute supervised treadmill session with the moving belt, safety bars, and general usability. To determine a personalized speed range, participants will start walking at 50% of their maximal walking speed, calculated in their 6MWT overground performance as the highest 15-second moving average. They need to confirm if that is their comfortable treadmill walking speed. If not, adjustments will be made. Participants will see a vertical visual scale in front of them to indicate perceived variations: verbal descriptors will indicate walking speed, with 0% representing comfort and +100% representing maximal walking speed. Afterwards, they will be instructed to adapt their gait to continuous belt acceleration toward their maximal walking speed. This is as familiarization with their personalized range of speed: they will be informed about every 10th step on the VAS (0-100), experiencing how it feels to walk at those speed levels.
Participants will walk on a treadmill with the speed systematically increasing and decreasing within the predefined individual range. The task lasts 6 minutes, starting with 1 minute at the self-selected comfortable speed. Then, speed increases for all participants by 1.5 km/h in 15 steps (0.1 km/h each) over 150 seconds, never exceeding the participant's max walking speed. After a brief plateau, imposed speed is decreasing in the same manner over 150 seconds. Speed changes occur at randomly timed intervals of 5-15 seconds each while verbal reports are prompted and recorded every 10 seconds. The choice of a fixed range of imposed speed, with identical magnitude and timing of speed increments, was defined after piloting the experiment with PwMS and HC to ensure a standardized comparison of absolute speed changes between groups. In order to not alter the participants' gait pattern on the treadmill, we avoided the use of a safety harness, what was also not needed for PwMS with mild impairment. Also, to remove external cues as treadmill sound, we ask participants to wear noise cancelling headphones playing white noise.
Protocol STS task - Chair for Interoceptive Assessment n.0 (CIA0) To impose STS difficulty variations, we mounted a standard chair on a hydraulic system that allows real-time seat height adjustments while an infrared optical sensor continuously measures the distance from the ground, ensuring precise control. This setup enables dynamic and personalized STS assessments and training and we believe it may open new possibilities for rehabilitation and tele-rehabilitation. The baseline seat height will be individually normalized to each participant's lower leg length (measured as the distance from the ground to the inferior margin of the patella). To define a personalized range of imposed difficulty, the seat height will be adjusted between ±20% of this baseline, with the lowest height representing the most challenging condition. Participants will familiarize themselves with each STS level by performing transitions at different seat heights while being informed of their corresponding position on a vertical visual scale (every 10th step, ranging from 0% comfort to -100% minimal seat height).
Participants will perform STS transitions at a fixed pace and completing one repetition every 10 seconds, but always starting from a standing position, sitting down and immediately after shifting their weight on the chair stand up as quickly as possible. No specific instructions are given about the stand-to-sit phase, considered as part of the perceptive strategy. To ensure they rely solely on movement perception, they look straight ahead not receiving any feedback on seat height changes. During the stance phase in between STS repetitions, the seat height will be modified starting from the baseline (comfortable seat-height= lower leg length + its 20%) with fixed decrements (5% of lower leg length) but with randomized number of repetitions (0, 1 or 2) in between variations in seat height. The seat-height lowering will continue down to the personalized lowest seat-height (not having safety constraints in this case), stabilizing on that value before increasing toward the baseline height. After each repetition, participants will verbally report the number corresponding to their perceived difficulty level based on the pre-established scale.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Multiple Sclerosis | – | –Inclusion criteria: Age between 18 and 70 years old; a diagnosis of MS (2017 revisions of the McDonalds criteria); ability to walk for 6 minutes without rest and without the need of a walking aid; ability to repeatedly perform the sit to stand transitions on a standard chair (43cm seat height) without hand support. Additionally, no relapses >1 month preceding the start of the study. Exclusion criteria: cognitive impairment hindering understanding of study instructions, pregnancy, and musculoskeletal disorders in the lower limbs (not related to MS), cardiovascular red flags for exercise (screened with Physical Activity Readines Questionnaire), other diagnosis for neurological or metabolic disease limiting the full execution of the tests (eg. peripheral neuropathy altering the foot plantar sensibility). |
| Healthy Controls | – | –Age and sex matching is ensured within a five-year range per Healthy Contol. Exclusion criteria: cognitive impairment hindering understanding of study instructions, pregnancy, and musculoskeletal disorders in the lower limbs, cardiovascular red flags for exercise (screened with Physical Activity Readines Questionnaire), other diagnosis for neurological or metabolic disease limiting the full execution of the tests (eg. peripheral neuropathy altering the foot plantar sensibility). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 44 PwMS and 44 healthy controls will be recruited from the Flemish MS rehabilitation centers in Melsbroek (NMSC) and Pelt (Noorderhart RMSC), and as well from the REVAL research center in UHasselt. No economical compensation will be provided. We will search age and sex-matching healthy controls, considering a 5-year range per subject. After giving informed consent, demographics of age and gender, height and weight, years of education, as well as MS-related information such as EDSS, type of MS, use of assistive device for walking in daily life, and year of diagnosis, will be collected and provided by the centers or via self-report. The participants will be instructed to keep their normal routine but to avoid extraneous physical activity at least 24 hours before the data collection session.
Key inclusion criteria (6 listed)
- age between 18 and 70 years old
- ability to walk for 6 minutes without rest and without the need of a walking aid
- ability to repeatedly perform the sit to stand transitions on a standard chair (43cm seat height) without hand support
- For People with Multiple Sclerosis group
- a diagnosis of MS (2017 revisions of the McDonalds criteria)
Key exclusion criteria (5 listed)
- cognitive impairment hindering understanding of study instructions
- ongoing or suspected pregnancy
- musculoskeletal disorders in the lower limbs
- cardiovascular red flags for exercise (screened with Physical Activity Readines Questionnaire)
- other diagnosis for neurological or metabolic disease limiting the full execution of the tests
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
Perceptive Sensitivity
Time frame: Day 1
Ratio between participants' reporting frequency and actual variability in motor performance (e.g., gait and sit-to-stand [STS]), referred to as the 'Detection-rate.' Number of pinches is divided by the Coefficient of Variability (in %, of speed or smoothness parameter) in the studied time-window.
Detection Accuracy
Time frame: Day 1
Accuracy of detecting naturally occurring variations in self-paced gait and sit-to-stand (STS) performance. Objective change points (events) in speed/smoothness are identified using peak detection algorithms with a predefined threshold to extract only perceptually meaningful speed/smoothness fluctuations. Participants indicate perceived changes using a pinch gesture. A response is classified as correct if it occurs within a ±2-second window of a detected event. Responses outside this window or unmatched with any event are incorrect. Perceptive accuracy is modeled as a binary variable (correct/incorrect) and analyzed using mixed-effects logistic regression to account for repeated measures within subjects.
Correspondence Accuracy
Time frame: Day 2
Intra-subject correlation between perceived and actual imposed variations in walking speed or seat height, across different difficulty levels. Pearson correlations will study the linear relationship between the exercise difficulty and the reported difficulty. A Fisher Z transformation is carried out on all correlations before further analysis (group level comparisons across participants). -Detailed Picture of Each Phase: Average exercise difficulty and reported difficulty are calculated for every 30 s (or 3 STS repetitions). Multiple mixed model analyses are performed on the phases separately, with exercise difficulty and reported difficulty as dependent variables in separate analyses. Group (patient versus controls) and time are used as independent variables in all analyses. To control for potential baseline differences in any of the outcome variables exercise and reported difficulty in the last 30 s of the baseline phase are added as covariates in the analyses.
6 secondary outcomes
Confidence Rating
Time frame: Day 1 and 2
Perceptive Awareness
Time frame: Day 1 and 2
Interoceptive Sensibility
Time frame: Day 1
Proprioceptive Sensibility
Time frame: Day 1
Interoceptive Sensitivity and Attention Questionnaire (ISAQ)
Time frame: Day 1
6 minutes walking test
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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, run by Hasselt University at 3 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptive Sensitivity (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 28 Jul 2026.