Laval

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

This research aims to evaluate the effectiveness of a carbon ankle foot orthosis (AFO) compared to a standard plastic ankle foot orthosis in helping patients with foot drop achieve their personal walking goals. Foot drop is a walking disability seen in various nerve or muscle disorders that affects patient autonomy and quality of life. The study uses the Goal Attainment Scaling (GAS) to measure how well patients meet their personal goals while using each device. Participants will use both types of ankle foot orthoses in alternating phases: first a standard plastic AFO, then a carbon medical device AFO, followed again by the plastic AFO, and finally the carbon AFO. Each phase involves wearing the device three times a week for 12 weeks. This design allows comparison of the two devices in the management of walking functional impairment. During the study, patients will be monitored for their ability to achieve personal goals while wearing the devices. Researchers will track walking function and assess outcomes through the GAS scale. The total study duration includes multiple phases of device use, with patient follow-up for 12 weeks to ensure proper evaluation and safety.

Chronic pain, especially in the upper limbs, greatly affects quality of life and lacks a single effective medical treatment. This study evaluates the use of immersive virtual reality (IVR) as part of a rehabilitation program to improve upper limb function in patients with chronic pain. The research uses a single-case experimental design to explore whether IVR during occupational therapy sessions can enhance rehabilitation outcomes. Participants will undergo three study phases: baseline, intervention, and follow-up. The IVR device called H'ability will be introduced during the intervention phase at randomized sessions between sessions 4 and 7 with an occupational therapist. The study involves 12 participants who serve as their own controls, receiving IVR exclusively during the intervention. During the study, upper limb function will be assessed five times per week for seven weeks using the Quick DASH self-questionnaire. Pain intensity and pain self-efficacy will also be measured. Researchers will compare results across phases and subjects to evaluate the impact of IVR sessions. The total study duration includes baseline, intervention, and follow-up periods to monitor safety and long-term effects.

Researchers are evaluating a new care pathway using Automated Dynamic Laximetry (ADL) for patients with suspected knee sprains involving partial or complete anterior cruciate ligament (ACL) lesions. This study compares the ADL method to the current standard, magnetic resonance imaging (MRI), which is generally used to confirm diagnosis and assess injury severity. Prior research has shown that ADL performs similarly to MRI in diagnosing knee sprains and assessing severity, suggesting that ADL could offer faster diagnosis and potentially reduce care costs. Participants are divided into two groups. One group follows the new care pathway where, after immobilizing the injured limb with a Zimmer splint, they are referred to a sports physician to perform ADL as a confirmatory test. Patients arrange this appointment as soon as possible after the emergency visit. The control group receives the standard care pathway, including immobilization with a Zimmer splint, an MRI scan, and consultation with their chosen doctor. Post-MRI, patients continue their care as usual depending on their diagnosis. During the study, participants complete questionnaires assessing knee function and quality of life at inclusion and again at 1, 3, 6, and 12 months. These include the KOOS questionnaire, EQ-5D-5L questionnaire, and Tegner activity scale. The study monitors patient outcomes over a year to evaluate the effectiveness and impact of the new care approach compared to standard MRI-based treatment.

This research aims to evaluate the pain and discomfort experienced by patients with reduced or very reduced mobility when using the bedpan currently in use. The study is based on the hypothesis that the standard bedpan does not suit the diverse needs of patients in various hospital departments. It focuses on bedridden patients aged 18 and older who require bedpan use during a hospital stay of at least two days. Participants will be observed and questioned about their experience with the bedpan during hygiene care over two days. The study involves collecting patient and caregiver feedback on pain, discomfort, and any changes to the patient's skin condition, such as redness or early-stage pressure sores caused by bedpan use. The total time to gather this information is estimated to be about 15 minutes per patient. During the study, pain will be assessed through four evaluations within 48 hours while patients use the bedpan. Caregivers will monitor skin condition changes objectively. The study also records patient opinions on bedpan use to validate the hypothesis. Participants must understand the protocol and provide oral consent. The overall participation duration aligns with the hospital stay of at least two days.

Calciphylaxis is a rare and painful condition causing ischemic skin lesions due to blocked small blood vessels, mainly affecting patients with end-stage renal disease on hemodialysis. Researchers are conducting a prospective randomized controlled trial to evaluate the safety and effectiveness of adding rheopheresis treatment to standard care for these patients. Rheopheresis is a procedure using double-filtration plasmapheresis to remove specific high molecular weight proteins involved in inflammation and blood clotting. Participants will be randomly assigned to receive either rheopheresis or a sham-apheresis as an additional treatment alongside standard care. Rheopheresis is performed using an automated device (Plasauto) that filters plasma in a double-filtration process, while sham-apheresis uses the same device but returns untreated plasma to the patient. A total of 17 treatment sessions are planned over 12 weeks. During the study, participants will be monitored for complete healing of their calciphylaxis-related skin lesions after 12 weeks of treatment. The trial includes assessments of wound healing progress and safety measures. Participants must be adults on hemodialysis with calciphylaxis lesions, and the study aims to determine if rheopheresis improves healing compared to standard care alone.

Researchers are evaluating the feasibility of using immersive virtual reality (VR) technology within a functional restoration program (FRP) for adults aged 18 to 65 with chronic low back pain (CLBP). This pilot study focuses on how acceptable and usable the VR headset is for both patients and healthcare providers involved in group-based rehabilitation. Chronic low back pain significantly reduces quality of life and current rehabilitation methods aim to improve physical function through multidisciplinary care. The study explores the novel integration of VR, which has shown potential in reducing pain and enhancing motor skills, into these programs to improve rehabilitation outcomes. Participants will undergo standard FRP rehabilitation, including physiotherapy, hydrotherapy, occupational therapy, adapted physical activity, and educational workshops. In addition, patients will participate in three weekly VR sessions lasting 20 minutes each over a 4 to 5 week period. These VR sessions involve pre-programmed exercises using an immersive, wireless headset designed to promote trunk movements such as flexion, extension, inclination, and rotation. Healthcare providers will assist patients with device setup and monitor sessions to ensure safety. Throughout the study, patients will complete questionnaires assessing pain, kinesiophobia, motor imagery, and usability of the VR device at baseline, during the program, and at its conclusion. Pain levels will be measured before and after each VR session, and adherence to VR use will be tracked weekly. The primary outcome is the acceptance of the VR system on the last day of the FRP. This study aims to provide valuable insights into the practical use of VR in rehabilitation and inform larger trials to evaluate its long-term benefits for patients with chronic low back pain.