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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the use of laryngeal transplantation to restore laryngeal function in patients who have suffered severe trauma to the larynx that cannot be treated with conventional methods. This trial involves a small group of three adult patients who have permanent loss of laryngeal function, which significantly impacts their ability to speak, breathe, and swallow, thus reducing their quality of life and causing social isolation. The study aims to analyze these cases before and after transplantation to determine if this approach can improve patient outcomes where other reconstructive surgeries have failed. The intervention being assessed is laryngeal transplantation, performed with a specialized nerve re-innervation technique designed to help patients breathe without a tracheotomy tube and improve functional recovery of the transplanted tissue. The study uses a dual immunosuppressive therapy regimen tailored to the graft type and patient condition. Each patient will receive this transplantation and be closely monitored throughout the study. Participants will be followed for three years after transplantation, with assessments including swallowing function evaluated by the Deglutition Handicap Index, voice quality measured through patient questionnaires (Voice Handicap Index), respiration assessed by the ability to remove the tracheotomy tube, and graft survival. The study includes comprehensive psychological evaluation before transplantation and continuous monitoring of clinical and biological status to ensure safety and effectiveness of the treatment over time.
Actively Recruiting
Healthy Volunteer
Researchers are investigating whether active cycling assisted by functional electrical stimulation (FES) is more effective than active cycling alone in improving cardiovascular fitness in adults with hemiparesis after a stroke. This single-blind, randomized, controlled trial focuses on patients who have experienced a unilateral first stroke and have hemiparesis. The study aims to assess the effects of FES cycling on cardiovascular health measured by peak oxygen consumption (VO2 peak) over 8 weeks. Participants will be randomly assigned to one of two groups: one group will perform 30 minutes of active leg cycling with FES applied to specific muscles on the affected side, while the other group will do the same cycling with sham FES. Both groups will train three times per week for 8 weeks, seated on a specialized device called the FES-Cycle (Hepha Bike, Kurage), which combines a cycling ergometer with an 8-channel electrical stimulator. Alongside the study treatment, participants will continue their usual rehabilitation programs. Participants will be evaluated before starting training, immediately after the 8-week treatment period, and again at a 3-month follow-up visit. Researchers will measure cardiovascular fitness using VO2 peak and monitor participants' safety and progress throughout the study. The total participation includes the treatment phase and follow-up assessments to understand the lasting effects of the intervention.
Actively Recruiting
Researchers are evaluating the effects of a local vibration program applied to the dorsiflexor muscles on neuromotor recovery in patients undergoing subacute rehabilitation after a stroke. The study aims to determine if adding vibration therapy to a standard rehabilitation program improves walking speed compared to rehabilitation alone. The trial focuses on patients who have experienced ischemic or hemorrhagic strokes and are in the early recovery phase between 14 days and 3 months post-stroke. Participants will be randomly assigned to one of two groups: an experimental group receiving effective local vibrations at 100Hz on the paretic limb's dorsiflexor muscles, and a control group receiving sham vibration without actual vibration. Both groups will undergo 40 sessions over 8 weeks, with 5 sessions per week during hospitalization. The study includes various assessments such as the 10 meters Walk Test and 2 Minute Walk Test to measure walking speed, as well as evaluations of motor skills, muscle tone, autonomy, neuromuscular fatigue, and gait analysis. Throughout the study, participants will complete multiple tests and questionnaires including the Fugl-Meyer assessment, Modified Ashworth scale, ABILOCO questionnaire, Barthel index, electromyograms, and gait kinematics analysis. Researchers will monitor gait speed primarily at 2 months and collect data on muscle strength, fatigue, and functional autonomy. The total participation lasts for the 8-week intervention period with ongoing evaluations to assess recovery progress and safety.
Actively Recruiting
Researchers are investigating how tailored educational support can help patients with acute cardiovascular conditions, specifically acute myocardial infarction or acute decompensated heart failure, who have low health literacy. Health literacy affects a person's ability to understand health information and follow medical instructions, and many people in Europe have limited health literacy, which is linked to more hospital readmissions, poor health outcomes, and increased healthcare costs. This study aims to reduce medication errors and misuse after hospital discharge by improving understanding of treatment instructions in patients with low health literacy. The study evaluates an educational toolkit designed specifically for patients with low health literacy, created with input from patients and healthcare professionals. Participants receive three interviews with a trained health advisor: two in-person sessions before discharge and a follow-up phone call within three weeks after leaving the hospital. The nurse uses personalized tools to explain the discharge medication plan and how to handle potential situations. Additionally, two phone interviews with a clinical research assistant occur at 30 and 90 days post-discharge to complete questionnaires. Participants will be actively involved through interviews and questionnaires assessing their understanding and use of prescribed treatments. Researchers will monitor medication errors or misuse within 30 days after discharge as the primary outcome. The study includes safety follow-up and evaluates how well patients retain information and adhere to medical advice, with a focus on those returning home after an acute cardiovascular event. The total duration of involvement spans at least 90 days following hospital discharge.