Accuracy of Motor Performance Perception in Multiple Sclerosis

NCT07175792 | Recruiting

• 1 other identifier: B1152024000009
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

Motor Performance; Task-specific; Perception; Multiple Sclerosis; Walking; Sit-to-stand; Inteoception

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Day 2

Secondary Outcomes (6)

• Confidence Rating

  Day 1 and 2

• Perceptive Awareness

  Day 1 and 2

• Interoceptive Sensibility

  Day 1

• Proprioceptive Sensibility

  Day 1

• Interoceptive Sensitivity and Attention Questionnaire (ISAQ)

  Day 1

Other Outcomes (28)

• Visual Analogic Scale for Fatigue

  Day 1 and 2

• Hospital Anxiety and Depression Scale (HADS)

  Day 1

• Positive and Negative Affect Schedule (PANAS)

  Day 1

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Revalidatie & MS Centrum Overpelt: collaborator
• National MS Center Melsbroek: collaborator

Study Sites (3)

REVAL

Diepenbeek, Belgium, 3590, Belgium

RECRUITING

Noorderhart Revalidatie & MS

Overpelt, Belgium, 3900, Belgium

RECRUITING

Nationaal MS-Centrum Melsbroek

Steenokkerzeel, Belgium, 1820, 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 16, 2025
• Study Start: December 9, 2024
• Primary Completion: October 16, 2025
• Study Completion: December 9, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-09

Locations

BE (3)