About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
a diagnosis of MS (2017 revisions of the McDonalds criteria)
Disqualifiers
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)
Trial 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.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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).
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.
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).
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.
Other outcomes
Visual Analogic Scale for Fatigue
Self-reported fatigue levels assessed using a Visual Analog Scale (VAS) ranging from 0 ('not at all fatigued') to 10 ('extrimely fatigued'), measured before and after each experimental session (eg. 6MWT or STS experiments).
Hospital Anxiety and Depression Scale (HADS)
A two dimension scale (7 items subscale Depression, 7 items subscale Anxiety) developed to identify depression and anxiety among physically ill patients. Total score: 0-42. Higher scores represent higher Anxiety or depression.
Positive and Negative Affect Schedule (PANAS)
Brief scale to administer to assess positive and negative affect with 2 subscales of 10 items each. Range score is 10-50 for each subscale. Higher scores in each subscale represent higher positive (or negative) affect.
Fatigue Scale for Motor and Cognitive Functions (FSMC)
A 20-item questionnaire assessing how fatigue impact on quality of life. Fatigue severity scores range from 1 (Does not apply at all) to 5 (Applies completely), with higher scores indicating more severe fatigue and greater impact on daily activities.
Sponsors and contacts
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Hasselt University
Lead sponsor
Revalidatie & MS Centrum Overpelt
Collaborator
National MS Center Melsbroek
Collaborator