Aubière, France
Gait Assessment in Lumbar Spinal Stenosis
Phase
N/ASpan
103 weeksSponsor
Pamukkale UniversityDenizli
Recruiting
Healthy Volunteers
AI-Assisted Analysis of Range of Motion in Patients With Low Back Pain
Phase
N/ASpan
71 weeksSponsor
Pamukkale UniversityDenizli
Recruiting
Healthy Volunteers
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Phase
3Span
148 weeksSponsor
AmgenDenizli
Recruiting
Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms
This study aims to determine whether the application of music medicine is effective in reducing the symptoms experienced by female students during the menstrual period. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted with female students studying at Pamukkale University Faculty of Health Sciences. The data of the research will be collected between March 2024 and February 2025. Personal Information Form, Visual Analogue Scale and Menstruation Symptom Scale will be used to collect data. It was determined that a total of 62 people should participate in the research, 31 in the experimental group and 31 in the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed using the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.
Phase
N/ASpan
51 weeksSponsor
Pamukkale UniversityDenizli
Recruiting
Healthy Volunteers
The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy
This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted online with the parents of children with ventriküloperitoneal shunts at Pamukkale University Hospital. The data of the research will be collected between March 2024 and February 2025. In data collection, a personal information form will be used to determine the socio-demographic characteristics of the participants, a parent knowledge test will be used to evaluate their knowledge levels, and the General Self-Efficacy Scale and State and Trait Anxiety Scale will be used to evaluate the dependent variables. It was determined that 60 parents should participate in the study, 30 for the experimental group and 30 for the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed with the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.
Phase
N/ASpan
51 weeksSponsor
Pamukkale UniversityDenizli
Recruiting
Healthy Volunteers
Chronic Post Surgical Pain-Cardiac
Cardiovascular diseases pose a significant global health concern, particularly among the elderly population, leading to a surge in surgical interventions. Enhanced Recovery After Surgery (ERAS®) protocols, specifically ERAS® Cardiac, target improved perioperative pain management to optimize patient outcomes. Effective pain control aims to alleviate acute discomfort, prevent chronic pain development, facilitate early mobilization, reduce hospital stays, and enhance patient satisfaction and functional recovery. While pain intensity peaks within the initial days following cardiac surgery and gradually subsides, inadequate acute pain management can predispose patients to chronic pain, impairing their quality of life. Multimodal opioid-sparing analgesia strategies are recommended, with recent advancements in ultrasound-guided regional anesthesia techniques showing promise in enhancing acute pain relief and reducing opioid consumption, particularly through truncal fascial plane blocks and parasternal blocks. However, the impact of these techniques on chronic postsurgical pain remains incompletely understood. This multicenter study aims to investigate the incidence of chronic postsurgical pain following cardiac surgery, exploring the influence of various factors and their implications on patients' quality of life.
Phase
N/ASpan
77 weeksSponsor
Ondokuz Mayıs UniversityDenizli
Recruiting
Action Observation Therapy Via Telerehabilitation on Total Knee Arthroplasty Surgery
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery. The secondary aim is to investigate the effect of a telerehabilitation-based standard exercise program added to the home program (information leaflet) on patient-reported and performance-based outcomes. The surgical operations of all patients participating in the study will be performed by the same surgical team and a standard physiotherapy program will be applied to all patients until discharge. Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group. Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing. Telerehabilitation sessions will include information about the process and exercise training. Action observation therapy will include showing videos of the exercises in the exercise program. All patients will be evaluated before surgery and at the third, sixth, and twelfth weeks after discharge. Evaluations Descriptive Data: Descriptive data of the patients will be recorded using an evaluation form. Patient Reported Assessments: - Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee. - Pain intensity: Pain intensity will be assessed with the Visual Analog Scale (VAS). - Knee range of motion: Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia) - Quality of Life Assessment: Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Livings Scale (KOOS-ADLS) and EuroQol Group (EQ-5D) scales will be used for quality of life assessment.KOOS-ADLS is a scale used to detect symptoms and limitations in daily life tasks.The EQ-5D index scale consists of a questionnaire with five dimensions (movement, self-care, usual activities, pain/discomfort and anxiety/depression). - Physical activity assessment: International Physical Activity Survey (IPAQ-Short Form) and smart phone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week. - Patient Satisfaction Assessments: Patient satisfaction with telerehabilitation sessions will be assessed. Technical quality (such as reliability of technology, quality of audio/video synchronization, quality of image, quality of sound), achievement of treatment goals of the session and overall satisfaction with the session will be questioned. Performance Based Assessments: The tests recommended by the research groups of 30 seconds of sit and stand, 40 meters fast walking and stair climbing will be used. - Lower extremity muscle strength: Lower extremity muscle strength will be assessed by 30 seconds sit and stand test. - Walking speed: In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded. - Locomotor performance: Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible.
Phase
N/ASpan
109 weeksSponsor
Pamukkale UniversityDenizli
Recruiting
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
This is a multicenter, open-label, uncontrolled, non-comparative, fixed-dose study. The primary objective is to assess safety and tolerability of OMS906 in patients with C3G or idiopathic ICGN, both complement-mediated disorders. Patients will receive 5 mg/kg administered as intravenous (IV) infusions at 4-week intervals. The study will enroll up to approximately 20 patients with C3G or ICGN. Safety will be evaluated in all patients and by disease cohort. Preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) will be evaluated by disease cohort.
Phase
2Span
113 weeksSponsor
Omeros CorporationDenizli
Recruiting
Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery
Treatment of rotator cuff tears can be conservative or surgical. The aim of rehabilitation postoperative period, is to reduce pain, increase joint range of motion (ROM), and enable the patient to return to normal functional activities as soon as possible while preventing the repaired tissue from tearing again. Motor control training based on motor control theory reorganizes the cerebral cortex. In people with shoulder pain, a scapulothoracic posture retraining program reduces shoulder pain and improves scapulothoracic movement and muscle activation patterns and shoulder function. Therefore, rehabilitation should include correct positioning of the scapulothoracic joint through active muscle activation (motor control training) and retraining. However, the evidence is still limited and the effect of motor control exercises is not yet fully understood. Over the last 15 years, telerehabilitation in the broader field of telehealth has been used to help patients in rural areas improve healthcare and access services to reduce cost and transportation issues. Studies on the upper extremity have also begun to increase in recent years. The aim of the study is to examine the effect of motor control exercises given through telerehabilitation on shoulder function and quality of life in patients undergoing rotator cuff surgery.
Phase
N/ASpan
103 weeksSponsor
Pamukkale UniversityDenizli
Recruiting
Healthy Volunteers
Clinical Evaluation of Moment Tumor Hip Replacement Products
This study is a 6-center, prospective local medical device clinical trial. Trial period is 6 months. Patient recruitment will continue until the target sample number determined by the power analysis is reached. Since the application is surgical, it is within the scope of a one-time application. The patients will be followed for 6 months from the day of surgery. The study was designed as a prospective cohort study planned to be cross-sectional. The aim of this study is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used and to contribute to the medical literature on proximal femoral resection prosthesis as a result of the study.
Phase
N/ASpan
138 weeksSponsor
Estas Tıbbi Mamülleri MedikalDenizli
Recruiting