Clinical trials

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

The goal of this observational study is to evaluate the extent to which physiotherapy sessions in Flemish nursing homes adhere to the IAGG-GARN guidelines and to explore factors influencing clinical practice among physiotherapists. The study targets multiple nursing homes across Flanders, with 3 to 5 centers in each of the provinces of Limburg, Antwerp, and Flemish Brabant. This selection ensures variation in geographic location and organizational context. The participants in this study are physiotherapists working in the participating nursing homes. The main questions it aims to answer are: * To what extent do the physiotherapy sessions align with the IAGG-GARN guidelines? * Are there differences in physiotherapy session content and volume according to physiotherapist characteristics and resident characteristics? * What barriers and facilitators do physiotherapists experience when implementing guideline-based practice in Flemish nursing homes? Researchers will observe physiotherapy sessions delivered as part of routine care and document session content and duration using structured observation diaries. Participating physiotherapists will also take part in focus groups discussing experiences with guideline implementation, barriers, facilitators, and clinical decision-making.

The goal of this clinical trial is to learn how older adults respond to power training when the level of fatigue during exercise is different. Power training means performing fast movements with moderate loads to improve strength, power and mobility. The main questions the study aims to answer are: * How does the level of fatigue during power training acutely affect strength, movement, and muscle function? * How does it affect recovery, muscle soreness, and how hard the exercise feels? Researchers will compare three power-training sessions with different fatigue levels to see which approach may be safest and most effective for older adults. Participants will be healthy older adults aged 65 to 85 years. Each participant will complete three supervised exercise sessions on a leg press machine. The sessions will take place about one week apart. During the study, participants will: * Perform power training on a pneumatic leg press machine * Complete strength and mobility tests before and after exercise * Provide small blood samples to measure body responses to exercise * Rate how hard the exercise feels * Report muscle soreness for up to two days after exercise The results may help researchers design safer and more effective power-training programs to improve strength, mobility, and recovery in older adults.

The goal of this clinical trial is to learn if exercise training of high or moderate intensity is most optimal to improve brain health and prevent neurodegeneration in type 2 diabetes patients. The main question it aims to answer is: What is the effect of exercise training of high vs. moderate intensity on brain metabolism, brain perfusion, and cognition in type 2 diabetes? Researchers will compare the exercise training groups to a control group without exercise training to determine the effect of exercise training on the brain in type 2 diabetes. Participants will exercise for 6 months, 3 times per week. Before and after these 6 months, they will undergo: * a brain MRI scan * cognitive tests * blood sampling

Walking and motor control impairments are among the most common manifestations experienced by people with multiple sclerosis (pwMS) and may already be present in individuals with mild disability. Subtle changes in walking performance can reflect early disease progression, highlighting the need for sensitive clinical outcome measures that capture complex, real-world mobility. Commonly used assessments primarily quantify time or distance and may lack sensitivity to detect early or subtle functional changes in daily-life walking. Successful everyday mobility requires gait adaptability, defined as the ability to continuously adjust walking patterns in response to environmental or task-related challenges, including the processing of external perturbations and internal factors such as fatigue, balance confidence, and fear of falling. Despite its clinical relevance, gait adaptability is not specifically addressed by currently validated clinical tests in pwMS. The Walking Adaptability Ladder Test (WALT), which challenges the interaction between step length, cadence, and walking speed through continuous adjustments, and the Foot Tap Test (FTT), which assesses lower limb motor control and rhythmic coordination, have demonstrated promising measurement properties in other populations but have not yet been evaluated in pwMS. The primary aim of this study is to examine the test-retest reliability and construct validity of the WALT and FTT in pwMS with mild disability. Secondary aims include evaluating the measurement properties of the Balance Recovery Scale and the Gait-Specific Attention Scale in pwMS with mild disability, identifying inertial measurement unit-derived metrics that best discriminate pwMS with low disability from healthy controls, and exploring whether relationships between clinical motor test outcomes and self-reported measures provide complementary insights into subtle gait impairments.

The aim of this study is to measure task-specific maximal strength and motor fatigability during functional daily activities involving the upper limbs in typically developing children. The focus is on determining the test-retest reliability of these measurements. In addition, the results are compared with existing data from children with cerebral palsy (CP). Through this comparison, we aim to gain insight into the motor limitations experienced by children with CP when performing everyday tasks.

A large proportion of pregnant women develop pregnancy-related low back and/or pelvic girdle pain (PPGP), which often does not recover spontaneously postpartum. As a result, 10% of women with PPGP are thus crucial. However, the underlying mechanisms of PPGP are still poorly understood. The main objective of this study is to investigate whether lumbar proprioceptive deficits, a disturbed body perception at the lumbar spine, psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) and increased serum concentrations of specific inflammatory mediators are associated with (1) a reduced postural control and (2) the development and/or persistence of PPGP in multiparous women during the first and third trimester of pregnancy, and six weeks and six months postpartum.

According to the World Health Organization (WHO), chronic diseases are a major global public health concern and the leading cause of mortality worldwide. In the absence of evidence-based actions, the global annual deaths from chronic diseases are projected to rise to 55 million deaths in 2030, accompanied by a substantial increase in socio-economic costs. In this context, the WHO identifies type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD) as key chronic conditions of concern related to cardiometabolic health. Both sedentary behaviour (SB) and physical inactivity have been recognised as interdependent risk factors for the development of T2DM and CVD. SB refers to any waking behaviour, characterised by a low energy expenditure, while being in a sitting or reclining posture, whereas physical inactivity denotes insufficient levels (\<150 min per week,) of moderate-to-vigorous physical activity (MVPA). Studies using objective measures have demonstrated that on average Western adults spend 8-12h in SB per day, of which the majority is spent in prolonged sedentary bouts (lasting ≥30 min). In addition, up to 30% of adults worldwide are physically inactive, with higher levels of inactivity in high-income countries. Within this context, it has become evident that excessive prolonged SB, often in combination with physical inactivity, negatively impacts cardiometabolic health, contributing to insulin resistance, increased adiposity, poor lipid profiles and endothelial dysfunction. Given their detrimental effects on T2DM and CVD, strategies aimed at reducing SB and promoting physical activity (PA) warrant further investigation. Reducing and regularly interrupting SB, even with low-intensity PA, alongside sufficient MVPA, is crucial for maintaining a healthy cardiometabolic profile. Reflecting this, the WHO guidelines advise individuals to engage in 150-300 minutes of moderate-intensity physical activity, 75-150 minutes of vigorous-intensity physical activity, or an equivalent combination each week. Notably, the 2020 WHO guidelines also included recommendations on SB for the first time, emphasizing the importance of limiting sedentary time. The WHO states that replacing SB with physical activity of any intensity can yield health benefits. However, these recommendations remain non-prescriptive and somewhat vague, primarily due to a lack of robust scientific evidence on the optimal frequency, intensity, and duration of PA needed to interrupt sedentary time. The absence of specific guidelines on prolonged SB reflects this evidence gap. To support policy development, well-designed randomised controlled trials are needed to evaluate effective and practical strategies for reducing sedentary time. So far, the short term cardiometabolic health effects of SB interruptions have been investigated by our research group, laboratory studies of collaborators and other international researchers, demonstrating that; 1) more frequent SB interruptions especially affect glucose metabolism and insulin sensitivity; 2) higher intensity interruptions are associated with cardioprotective adaptations and; 3) longer durations of SB interruptions positively affect lipid metabolism. However, because under real-world conditions frequency, intensity and duration of SB interruptions usually interact, their combined effects on cardiometabolic health need further investigation. Many studies already compared the isolated effects of different SB interruption patterns with respect to frequency, duration and intensity on cardiometabolic health. However, the combined effects of these different approaches matched for energy expenditure are not clear yet. We therefore perform a balanced cross-over study in which the efficacy of distinct activity patterns on cardiometabolic health insulin sensitivity and vascular function) will be compared to a sedentary control condition.

Pregnancy-related lumbopelvic pain (PLPP) affects 50-90% of pregnant women and is often dismissed as a normal part of pregnancy. However, the long-term consequences can be dramatic. Up to 21% of women with PLPP still have pain three years postpartum, and 10% experience disability, poorer quality of life, and lower ability to work 11 years after delivery. Because the multifactorial etiology of PLPP is unclear, prevention and treatment fall short. Previous studies on the causes of PLPP focused on impairments in motor output but ignored that impairments in sensory input (e.g., proprioception, the primary expertise of our research group) often precede motor output problems. Moreover, though psychological factors such as fear (of movement) are known to affect PLPP, their predictive role in PLPP remains understudied. Finally, the role of systemic inflammation in PLPP has yet to be examined, despite recent studies demonstrating its role in the chronification of lumbopelvic pain in the general population. This prospective cohort study aims to identify new modifiable predictors for the onset of PLPP during pregnancy and its persistence postpartum. The investigators will compare sensory (proprioception, body perception), fear-related, and inflammatory factors between women with and without PLPP and determine their predictive role in the onset and persistence of PLPP. The results will increase our understanding of the multifactorial etiology of PLPP and help optimize prevention and treatment.

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.

The main objective of the study is to gain insights in how children learn a balance task and whether there is a difference between children with and without Developmental Coordination Disorder. Furthermore, the investigators are interested in the brain activity of these children while learning this new balance task.

Until now, cancer is still associated with high morbidity and mortality, and is therefore a big issue for the public health. Colorectal cancer is the second leading cause of cancer death in developed countries. In advanced colorectal cancer, 60% of these patients develop cachexia. The presence of cachexia plays an important role in the high mortality rate of cancer. Cachexia is characterized by involuntary weight loss with loss of skeletal muscle with or without loss of fat mass. The aim of this study is to determine the feasibility of taking muscle biopsies of cachectic colorectal cancer patients. Skeletal muscle characteristics will be compared between biopsies of the m. erector spinae and the m. vastus lateralis from cachectic colorectal cancer patients, non-cachectic colorectal cancer patients and healthy controls. 10 cachectic, 25 non-cachectic, and 25 healthy controls will be recruited for this study. It is an observational study, so measurements will be taken at one time point. Interventions/measurements: * muscle biopsies * blood samples * 3D freehand ultrasound * Short physical performance battery test * handgrip strength * questionnaires (activity pattern, quality of life)

Our society is characterized by a strong increase in the prevalence of obesity, which often causes the development of cardiovascular and metabolic diseases such as type 2 diabetes. The way(s) obesity is responsible for these diseases, is still insufficiently understood. This study therefore examines the content of human fat tissue storage location- and cell type-specific extracellular vesicles (EVs) in lean and obese individuals, and the possible connection with sex, insulin sensitivity, and the blood-brain barrier.

The goal of this mixed method study is to learn about how a dynamic arm support device (DAS) helps people with everyday activities. The study focuses on people with neuro(-muscular) conditions, age 16 and older. The research questions that are formulated, are: * How does a person experience their daily activities, with and without a DAS? * What are the contextual (external and personal) factors that influence the use of a DAS? Participants will take part in three testing sessions. In each session, they must complete a few questionnaires and participate in an interview. The first time, without DAS. In the second and third session, they will be using their DAS (resp. 3 to 4 weeks and 3 months). The data collection will be executed by phone, digital questionnaires and/or paper.

Positron emission tomography-computed tomography (PET-CT) is an important technique in lung cancer staging, where almost no lung lesion goes undetected. However, PET-CT often fails to discriminate between malignant and non-malignant PET-positive solitary pulmonary nodules (SPNs) with a specificity of only 23%. 40-50% of those patients are advised to repeat their CT after three to six months to follow up on their lesions' progression, delaying a clear and correct cancer diagnosis and subsequent therapy. In more than 10% of the patients with an SPN on the PET-CT scan, an uncertain lung cancer diagnosis based on the PET-positive lesion leads to surgery that appears to be unnecessary. This project aims to use the plasma glutamate concentration as a biomarker to complement PET-CT in the discrimination between malignant and non-malignant PET-positive SPNs. The investigators will validate a plasma glutamate determination by high- performance liquid chromatography (HPLC) since this test needs to be rapid, cheap, minimally invasive, and available in every hospital. In addition to the analysis of plasma glutamate, other plasma metabolites will be screened to check for other potential biomarkers to discriminate between malignant and non-malignant PET-positive SPNs. Together with the PET-CTs' basic parameters, a quick measurement of fasted plasma glutamate and potentially other biomarker levels right before undergoing a PET-CT scan will support a more rapid lung cancer diagnosis and treatment, resulting in less risk for disease progression. In conclusion, our approach will improve the accuracy of lung cancer diagnosis, and avoid unnecessary surgery.

To compare the cardiovascular profile of pre-conceptional women at risk for developing Gestational Hypertensive Disorders in subsequent pregnancy before and after physical activity.

The aim of this study is to asses the effect of a music and video-based group exercise therapy on motivation, physical functioning, cognition and well-being in older adults with moderate dementia.

This project is designed to: a) develop a new test called UHasselt Locomotor Sensory Integration Test (UHLSINT) which would allow us to evaluate sensory interaction process in locomotion assess whether Locomotor CTSIB and to investigate whether UHLSINT is a reliable test to evaluate sensory interaction in both young and older adults, b) evaluate the difference in sensory interaction and balance performance between standing and walking between both young and older adults, c) examine the changes in sensory interaction process under challenging conditions such as perturbations, dual-task, and when both are present between both young and older adults, d) examine the association between overall fall risk defined by the single-large perturbations and sensory interaction processes used during all the trials in both age groups. In order to achieve these aims, 10 trials will be conducted: Trial 1- Single-Large Perturbation in Standing Trial 2- Single-Large Perturbation in Walking Trial 3- Instrumented CTSIB Trial 4- Locomotor CTSIB Trial 5- Instrumented CTSIB + Perturbations Trial 6- Locomotor CTSIB + Perturbations Trial 7- Instrumented CTSIB + Auditory Stroop Test Trial 8- Locomotor CTSIB + Auditory Stroop Test Trial 9- Instrumented CTSIB + Perturbations + Auditory Stroop Test Trial 10- Locomotor CTSIB + Perturbations + Auditory Stroop Test Two different treadmill perturbations will be applied in addition to the Instrumented CTSIB and UHLSINT: a) slip perturbations, b) continuous perturbations. An auditory stroop task will be applied in relevant trials. All of the trials will be performed in CAREN High-End Systems (Motek Medical BV, Amsterdam, The Netherlands) which is a motion capture system that is equipped with a treadmill mounted on a 6 degree of freedom motion base, a 360º dome-shaped virtual reality (VR) screen, and a marker-based movement analysis system.

The overarching goal is to determine if the BOOST GAIT program can improve functional mobility in patients with stroke who are undergoing inpatient rehabilitation and have some walking function, through the application of augmented therapeutic exercises designed to achieve a normative gait pattern. The evaluation will be conducted using a combination of clinical scales and objective motion sensors that map walking quality and performance during activities of daily living, such as rising from a chair and standing. It is acknowledged that this single-group pilot study, which aims to include 12 participants, is insufficiently powered to address the primary objective. A larger parallel-design study is required to definitively address this issue. To help design a larger study, the current objectives are: first, to have realistic expectations regarding recruitment and dropout rates; second, to identify potential barriers to therapy adherence and data collection that may impede the success of a larger study; third, assess the test-retest reliability of sensor-based motion capture of movement quality during walking and related tasks in hemiparetic stroke patients. For the latter objective, the sensor measurements at the end of the intervention will be repeated on two consecutive days. In addition to their usual care, participants will undergo additional therapy over a four-week period, with sessions occurring five times per week for one hour as part of the BOOST GAIT program. The BOOST GAIT sessions will be conducted as group-based therapy with four patients and two physiotherapists present to oversee the performance of mobility-specific exercises, including sit-to-stand transfers, standing and stepping, and eventually walking. The rationale for this approach is that the combined effects of augmenting the amount of therapeutic exercises and specifically targeting motor control of the paretic leg will facilitate symmetry during tasks, which in turn will have carry-over effects on safe performance of walking and other mobility tasks.

Low back pain (LBP) is the leading cause of disability worldwide. Impaired postural control is a key factor in the development and maintenance of LBP. Moreover, the prevalence of LBP is associated with impairments in diaphragm function, symptoms of dyspnea, and dysfunctional breathing. However, the association between LBP (and more specifically postural control) and hyperventilation remains unknown. The main objective of this project is to investigate whether the presence of recurrent non-specific LBP is related to the presence of hyperventilation, when classified either objectively by decreased carbon dioxide values (demonstrating hypocapnia) or by symptoms while showing normal carbon dioxide values. Moreover, the investigators will explore whether psychosocial factors play a role in this relation. Subsequently, the investigators will examine whether hyperventilation in LBP patients is related to impaired postural control, and more specifically to a decreased postural contribution of the diaphragm.

Chronic low back pain (CLBP) is one of the most common chronic musculoskeletal disorder worldwide and is responsible for the highest levels of disability of all diseases. All state-of-the-art guidelines recommend implementing exercise therapy (ET) in CLBP management. Researchers have shown that a novel ET modality, namely high intensity training (HIT), can be valuable. A clinical evaluation study in a larger spectrum of persons with CLBP in a rehabilitation centre setting is essential. Thereby, technology might support HIT. The primary goal of this clinical trial is to evaluate the short- and long-term effectiveness of a time contingent individualized High intensity training (HIT) protocol on disability compared to moderate intensity training (MIT) in persons with severely disabling chronic low back pain (CLBP). Secondary goals entail 1) evaluating short- and long-term effectiveness of HIT on psychosocial correlates, central pain processing, and broad physical fitness, 2) investigating additional effects of (prolonged) HIT at home, 3) investigating added value of technology through a mobile (smartphone) and dashboard (computer) application that offers support during home training, 4) evaluating cost-effectiveness of (technology supported) HIT compared to MIT. The main research question\[s\] (RQ) it aims to answer are: * RQ1: To what extent is HIT effective on the short- and long term to improve disability in persons with severely disabling CLBP compared to MIT as used in usual care? * RQ2a: To what extent does HIT have a short- and/or long-term effect on central pain processing and psychosocial correlates in persons with severely disabling CLBP? * RQ2b:To what extent does HIT have a short- and/or long-term effect on outcomes related to broad physical fitness in persons with severely disabling CLBP? * RQ3a: To what extent does prolonged (technology-supported) HIT at home provide additional training effects in persons with severely disabling CLBP? * RQ3b:To what extent does a mobile application that offers support for HIT at home provide added value for treatment outcomes of persons with severely disabling CLBP? * RQ3c:To what extent is the techno-HIT application usable and qualitative (assessed by SUS and uMARS) as a therapeutic support mechanism, as evaluated by persons with severely disabling CLBP? * RQ4: To what extent is HIT or HIT supported by a mobile application cost effective compared to MIT for patients with severely disabling CLBP?

Background: Multiple adaptations at the cardiovascular system occurs during pregnancy. In the pregnancy condition pre-eclampsia (PE), this adaptations are abnormal. Five to eight percent of all pregnant women worldwide will develop PE. PE is a pregnancy condition which is characterized with a high blood pressure (\>140/90 mm Hg) and the occurrence of proteinuria (\>3g/dl/24h) after 20 weeks of gestation. When untreated, this condition can have severe complications for both mother and child. It's important to monitor women with a high risk for developing PE for an early detection and treatment of this condition. For this reason, a multicenter study is set up with the following applications: 1. NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography of the heart and veins. 2. Maltron: bio-electronic impedance analyze 3. Remote monitoring of the high risk patients to become a more intensive follow-up Number of inclusions: 2000 pregnant women from the prenatal consultations of eight different hospitals:

Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Additionally, the group of patients with non-specific low back pain will receive a 16-week, high-load proprioceptive training program. The effects of this training program on the different back muscle characteristics and proprioceptive postural control will be evaluated.