Clinical trials

This study aims to compare the effects of time-restricted eating (TRE, 16/8) in adults with obesity who have and have not undergone bariatric surgery (BS). The study will include adults aged 18-65 years: those with obesity who have not undergone BS, and those who have experienced insufficient weight loss (IWL) or weight regain (WR) following BS. Both groups will follow a 16:8 time-restricted eating protocol for 6 weeks, with an 8-hour eating window recommended between 10:00 AM and 6:00 PM, though participants may adjust to other 16-hour fasting windows. Participants will be evaluated before and after the intervention in terms of anthropometric measurements, biochemical parameters, and dietary habits. The study is being conducted at a private hospital in Bursa, Turkey, and is planned to be completed with a total of 40 participants (20 per group).

This study evaluates the antibacterial effectiveness of two different intracanal medicaments, Bio-C Temp and UltraCal XS , in mandibular molar teeth with chronic apical periodontitis. Intracanal bacterial load is assessed before and after root canal preparation, after intracanal medicament removal, and after final irrigation using droplet digital PCR.

Rotator cuff tears negatively affect shoulder stability, range of motion, and performance in daily activities. Postoperative rehabilitation is essential for improving functional recovery and quality of life; however, conventional approaches may not directly target meaningful activity performance. Task-oriented occupational therapy is a client-centered approach focusing on meaningful and goal-directed activities to enhance functional independence. This randomized controlled trial aims to investigate the effect of task-oriented occupational therapy on activity participation, occupational performance, satisfaction, and functional recovery after rotator cuff surgery. A total of 30 participants will be randomly assigned to either a task-oriented occupational therapy group or a conventional rehabilitation group. The intervention will be conducted twice weekly for 10 weeks, with 40-minute sessions based on individually prioritized activities identified using the Canadian Occupational Performance Measure. Outcomes will include occupational performance and satisfaction, goal attainment, shoulder function, quality of life, and patient satisfaction.

This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Central sensitization, characterized by an increased responsiveness of the central nervous system to pain stimuli, has been associated with persistent pain and poor functional recovery in various musculoskeletal disorders. However, its impact on outcomes following arthroscopic rotator cuff repair has not been fully elucidated. Adult patients diagnosed with a rotator cuff tear by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be enrolled. Preoperative central sensitization will be assessed using the Central Sensitization Inventory (CSI), while pain intensity and shoulder function will be evaluated using the Visual Analog Scale (VAS) and the Shoulder Pain and Disability Index (SPADI), respectively. Clinical assessments will be performed preoperatively and at postoperative 3 months. The study aims to determine whether preoperative central sensitization is associated with postoperative pain and functional recovery after arthroscopic rotator cuff repair.

Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.

Meniscal tears are among the most common knee injuries and frequently require arthroscopic surgical treatment when conservative management fails or mechanical symptoms persist. Although surgical techniques have improved clinical outcomes, postoperative recovery is influenced not only by structural pathology but also by psychological factors. Kinesiophobia, defined as an excessive and debilitating fear of movement due to pain or the expectation of reinjury, may negatively affect rehabilitation adherence, functional recovery, and pain perception. This prospective observational study aims to investigate the effect of preoperative kinesiophobia on postoperative clinical outcomes in patients undergoing arthroscopic surgery for meniscal tears. Adult patients diagnosed with a meniscal tear by clinical examination and magnetic resonance imaging and scheduled for arthroscopic surgery will be enrolled. Preoperative demographic and clinical characteristics, pain intensity, functional status, and kinesiophobia levels will be assessed using validated outcome measures. Postoperative evaluations will be performed three months after surgery to determine changes in pain and functional outcomes. The relationship between preoperative kinesiophobia and postoperative clinical success will be analyzed. The findings of this study may help identify patients at risk for suboptimal recovery and support the development of individualized rehabilitation strategies.

This randomized controlled trial aims to investigate the effects of a structured visual skills-based occupational therapy program on visual perception and school-based visual-motor functions in typically developing primary school students aged 8-10 years. Participants will be randomly assigned to either an intervention group receiving a 6-week visual skills program or a control group receiving routine school activities and home-based assignments. Outcomes including visual perception, visual-motor performance, convergence ability, and motor proficiency will be assessed before and after the intervention.

Introduction: Stroke is a leading cause of long-term disability worldwide. Persistent lower-extremity motor and somatosensory impairments after stroke commonly limit walking and balance despite rehabilitation. Virtual reality (VR)-integrated robotic rehabilitation may support structured, goal-directed ankle-foot practice; however, there is limited evidence for ankle-foot-focused sensorimotor protocols. In particular, approaches that combine robot-assisted motor training with a plantar tactile localization task and VR-supported joint position sense (JPS) training to target plantar sensory and proprioceptive function are scarce. Therefore, this study aims to evaluate the effectiveness of a structured, VR-integrated, robot-assisted ankle-foot sensorimotor rehabilitation protocol in individuals with chronic stroke and to examine its effects on clinical and sensorimotor outcomes. Methods and analysis: This is an assessor-blinded, two-arm, parallel-group randomized controlled trial. Thirty individuals with chronic stroke will be randomized 1:1 to the Robot-assisted Training Group (RTG) or the Manual Training Group (MTG). All participants will receive conventional rehabilitation; in addition, RTG will receive a structured robot-assisted ankle-foot training program integrated with virtual reality and assist-as-needed control, whereas MTG will receive the same structured ankle-foot training protocol delivered manually by a physiotherapist. Interventions will be delivered three times per week for 6 weeks (18 sessions), and total session duration will be time-matched between groups (50-60 min per session). The primary outcome will be the change in walking speed, derived from the 10-Meter Walk Test, from baseline to 6 weeks. Secondary outcomes will include 2-Minute Walk Test distance, ankle range of motion, joint position sense, plantar tactile sensation, muscle tone, motor performance, static and dynamic balance, and stroke-specific quality of life.

This randomized controlled trial aims to compare the effects of ultrasound-guided lateral Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP) block on postoperative analgesia in patients undergoing laparoscopic inguinal hernia repair. Ninety patients will be randomly assigned to one of three groups: Group QLB, Group TFP, or Group Control. The primary objective is to compare postoperative pain scores (NRS) at various time points within the first 24 hours. Secondary objectives include evaluating the need for rescue analgesia, total tramadol consumption, and the incidence of opioid-related side effects.

This study evaluates the effectiveness of a web application-based exercise program (delivered via Physitrack) for managing non-specific low back pain (NSLBP) compared to traditional home exercise programs. The trial focuses on whether web-based delivery can improve pain, function, quality of life, and adherence, providing evidence for digital rehabilitation as a practical alternative to conventional physiotherapy.

This is a non-interventional, prospective observational study aimed at developing and validating an artificial intelligence-based system for assessing motor development in children using video analysis. Children aged 5 to 10 years will perform standardized motor tasks, which will be recorded under controlled conditions. The recorded videos will be analyzed using computer vision and deep learning techniques to extract movement patterns. The results of the AI-based analysis will be compared with standardized motor assessment scores obtained from the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2 SF). Participants will be classified into typical and atypical motor development groups based on BOT-2 scores. The primary objective is to evaluate the classification performance of the AI model. Secondary analyses will examine the relationship between AI predictions and continuous motor performance scores. The study is designed to explore whether motor development can be assessed objectively without direct clinical testing, using only short video recordings. The findings may contribute to the development of scalable and accessible digital screening tools for early identification of motor development differences in children.

Chronic low back pain (CLBP) is a leading cause of disability worldwide and affects a large proportion of working-age individuals. Cortical reorganization in CLBP, particularly within the sensorimotor cortex, has been shown to negatively influence sensory acuity and motor control. The neuroplasticity underlying this reorganization may enhance the effectiveness of sensorimotor retraining therapies that involve specific stimulus features targeting somatosensory cortical regions. This randomized controlled trial will include three groups: a device-assisted sensory acuity training group, a manual sensory acuity training group, and a control group receiving conventional physiotherapy. In this study, device-assisted sensory acuity training will be delivered using a standardized vibrotactile interface that presents controlled stimuli and records participant responses. The intervention will be structured to target sensory acuity components similar to those addressed in manual training. Accordingly, the structured training protocol will include: * localization training to improve detection of stimulus location, * orientation discrimination to identify stimulus direction, * temporal acuity training to distinguish timing differences between tactile stimuli and * graphesthesia training to improve recognition of shapes or letters drawn on the skin through tactile input. The primary aim of this study is to evaluate sensory acuity in individuals with CLBP and to determine the effects of a structured manual and technology-based sensory acuity training program, combined with conventional physiotherapy, on pain intensity (VAS), lumbar two-point discrimination, and a composite sensory acuity score. We hypothesize that adding manual and technology-based structured sensory acuity training (SAT) program to a conventional physiotherapy regimen including motor control exercises will support central nervous system reorganization, improve sensory profiles, and lead to improvements in pain-related variables, disability, and quality of life. Through this structured SAT program, we aim to provide an approach that evaluates and trains multiple dimensions of sensory acuity in CLBP, including localization, orientation, and temporal discrimination.

Preeclampsia and eclampsia are among the leading causes of maternal death and morbidity, and are obstetric emergencies that lead to serious complications during pregnancy. Preeclampsia affects 2-8% of pregnancies worldwide; approximately 46,000 maternal deaths and approximately 500,000 fetal or neonatal deaths occur annually due to preeclampsia. This situation highlights the importance of well-equipped midwifery care, especially in terms of early diagnosis, accurate assessment, emergency intervention, and effective management. Traditional teaching methods alone are insufficient for midwifery students to develop clinical decision-making skills in life-threatening situations such as preeclampsia and eclampsia, and to translate theoretical knowledge into practice. Therefore, new teaching approaches that support active learning, interaction, and decision-making processes in education are needed. In recent years, digital game-based learning has emerged as an innovative tool in health education with its potential to attract learners' attention, improve problem-solving skills, and increase their motivation. Especially for midwifery students, digital games facilitate experiential learning by providing a safe simulation environment in preparation for information overload and stressful clinical environments. However, the use of digital games in teaching complex clinical processes such as preeclampsia and eclampsia management has been researched to a limited extent. Scientifically examining the effects of such innovative methods on students' learning motivation, attitude, and active participation in the learning process in midwifery education will fill an important gap in the literature. In this context, evaluating digital game-based learning in preeclampsia-eclampsia management education by comparing it with simulation training and traditional teaching will make a significant contribution to both the midwifery education literature and the knowledge base regarding the use of technology in health education.

Liberation from mechanical ventilation involves three steps: weaning, readiness assessment, and extubation. Readiness is determined using clinical criteria such as improvement of the underlying condition, hemodynamic stability, and adequate respiratory effort. Successful extubation is defined as not requiring invasive support within 48 hours. Due to the complexity of ICU patients, various clinical parameters and multi-component scores have been developed to predict extubation success. This study aims to develop and evaluate a multi-component score, the Readiness for EXtubation score (REXs), to predict extubation readiness in ICU patients under invasive mechanical ventilation.

This trial investigates the first combined use of motor imagery and vestibular rehabilitation in multiple sclerosis, aiming to evaluate their joint effect on balance, cognition, and quality of life.

This prospective, open-label clinical trial aims to compare a novel "Venous Tourniquet with Regional Low-Dose Sugammadex" method against the gold standard "Arterial Tourniquet" (Isolated Forearm Technique - IFT) for monitoring motor seizure activity during Electroconvulsive Therapy (ECT). Using a within-subject (intra-individual) design, each of the 40 enrolled patients will receive an arterial tourniquet on one arm and a venous tourniquet on the other arm simultaneously. The study will evaluate clinical efficacy in observing motor seizures, comparing the duration and visibility between the two limbs of the same patient, as well as assessing overall patient comfort and hemodynamics.

This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia

This study aims to investigate the effects of Binaural Beats-supported music and virtual reality experience on the levels of oxytocin, prolactin, catecholamine, endorphin, prostaglandin E and cortisol, which are hormones that play an active role in birth, using the Elisa method. Additionally, the study will examine the effects of virtual reality experience and Binaural Beats-supported music during labor on labor pain and some birth outcomes (such as the presence of an episiotomy, the onset of labor, the duration of labor, and the newborn Apgar score).The randomized controlled study will consist of three groups: a virtual reality group, a Binaural Beats-supported music group, and a control group. The research will be completed with a total of 90 people, with 30 people in each group. The research will be conducted at the Maternity Ward of Istanbul Gaziosmanpaşa Training and Research Hospital. Ethics committee approval has been received for the research. Data collection has not yet begun. An application has been made to the hospital administration for institutional permission. The research will begin once the permissions are received.

This study aims to examine the relationship between occupational balance, time management, and perceived stress in university students enrolled in a double major program. Participants who voluntarily agree to participate and meet the inclusion criteria will complete online questionnaires assessing their socio-demographic characteristics, occupational balance, time management skills, and perceived stress levels.

This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour

This observational study aims to investigate the relationships between proprioception, causes of kinesiophobia, sensory processing characteristics, and functional recovery in individuals undergoing gonarthrosis surgery. Postoperative functional recovery can be influenced by sensorimotor and psychological factors such as impaired proprioception, fear of movement, and changes in sensory processing. However, the interaction between these factors has not been sufficiently clarified. Participants will complete a sociodemographic and clinical information form, the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), the Causes of Kinesiophobia Scale, and the Adolescent/Adult Sensory Profile. Proprioception will be assessed using the Joint Position Perception Test.

The goal of this clinical trial is to evaluate whether a structured parenting skills training intervention can improve maternal parenting self-efficacy, perceived social support, and infant developmental outcomes in mothers of preterm infants aged 6-12 months (corrected age). The main questions it aims to answer are: Does a parenting skills training intervention improve maternal parenting self-efficacy? Does the intervention increase mothers' perceived social support and positively influence infant developmental levels? Researchers will compare mothers who receive the parenting skills training intervention with a control group receiving standard care to determine whether the intervention leads to greater improvements in maternal and infant outcomes. Participants will: Complete baseline, post-intervention, and follow-up assessments of parenting self-efficacy and perceived social support Have their infants assessed using standardized developmental evaluation tools Participate in a structured, home-based parenting skills training program consisting of multiple sessions (intervention group only) Take part in semi-structured interviews before and after the intervention to share their experiences and perceived needs

This study aims to evaluate the efficacy of ultrasound-guided Serratus Posterior Superior (SPS) block compared to surgeon-administered intercostal blockade in preventing chronic pain at 3, 6, and 12 months following Video-Assisted Thoracoscopic Surgery (VATS).

This randomized, double-blind study compares the postoperative analgesic efficacy of ultrasound-guided Posterior Quadratus Lumborum Block (QLB) versus Quadroiliac Plane Block (QIPB) in pediatric patients aged 1-7 years undergoing unilateral undescended testis surgery.

Cerebral palsy (CP) is a group of disorders resulting from a permanent but non-progressive lesion in the developing brain, which affects the development of movement and posture and may lead to activity limitations. Upper extremity involvement is observed in approximately 60% of children with CP. Abnormal muscle tone, imbalance between agonist and antagonist muscles, spasticity, alignment problems, reduced muscle strength, and impaired motor control are among the upper extremity impairments seen in CP. As a result, hand use is typically affected in a way that negatively influences the performance of daily living activities. Upper extremity functionality and hand use are crucial for participation in daily life and overall quality of life in children with CP. In addition to conventional rehabilitation methods, advances in technology have introduced various new modalities for upper extremity rehabilitation. The aim of the present project is to investigate the effects of Leap Motion-based exercise intervention and Neuromuscular Electrical Stimulation (NMES) on hand functions in children with spastic CP. A total of 30 children aged 6-15 years with a diagnosis of spastic CP and distal upper extremity involvement will be included in the study. To evaluate eligibility according to the inclusion criteria, gross motor function level will be assessed using the Gross Motor Function Classification System (GMFCS); hand skills will be assessed using the Manual Ability Classification System (MACS); upper extremity muscle tone will be assessed using the Modified Ashworth Scale (MAS); and passive wrist extension range of motion (ROM) will be measured using an electronic goniometer. Following eligibility confirmation, baseline assessments will be conducted. At baseline wrist ROM will be measured using an electronic goniometer; selective motor control of the wrist will be assessed using the Selective Control of the Upper Extremity Scale (SCUES); hand functions will be evaluated using the Jebsen-Taylor Hand Function Test; daily hand use will be assessed using the ABILHAND-Kids; and wrist extensor and flexor strength and activation will be evaluated via surface electromyography (sEMG). All participants will then undergo a 4-week routine conventional exercise program (3 sessions per week, 40 minutes per session). At the end of this 4-week period assessments will be repeated (at week 4). Subsequently, the 30 children with CP will be randomly allocated into two groups: the Leap Motion Control group (n = 15) and the NMES group (n = 15). Both groups will receive an 8-week intervention consisting of 3 sessions per week, each lasting 60 minutes (20 minutes of Leap Motion-based exercises or 20 minutes of NMES application, in addition to 40 minutes of conventional exercises). At the end of the 8-week intervention, all assessments will be repeated ( at week 12). For statistical analyses, the Statistical Package for the Social Sciences (SPSS) Version 23.0 for Windows will be used.