Clinical trials

The study is a Random control trail study conducted at King Khalid University Hospital in Riyadh, Saudi Arabia, focusing on Application of 5 framework in rehabilitation program of knee arthritis. The study will involve a in each group sample of 20 KOA patients, with a 12-month duration. The sample size was estimated using G\*Power 3.1 software, and the initial power analysis indicated that 40 participants would be required to achieve 80.0% statistical power. The study's participants will be aged between 55 and 80 years, diagnosed with Knee osteoarthritis, without cognitive impairment, knee surgery in the past 6 months, or unstable comorbidities. The study will involve in-person 16 sessions, with the first two lasting approximately one hour and the remaining session 30-45 minutes. The main outcome measures that will be used in this study are Stay Independent Brochure, Iconographical Falls Efficacy Scale (icon-FES), Timed Up and Go, 2-Minute Walk Test, 5 Time Set to Stand Test AND Arthritis Self-Efficacy Scale 8 Item (ASES-8), Patient-Specific Functional Scale (PSFS), and Patient satisfaction level with Physical Therapy service MedRisk. Data will be taken from direct questions to patients, by filling out the questionnaire via Google Form, and through some tests and SPSS will be used for data analysis, with ANOVA Test intervention scores of the outcome measures.

This randomized controlled crossover trial investigates the acute effects of consuming dark, milk, and white chocolate before prolonged sitting on cardiovascular health in healthy adults. Each participant completes three separate study visits and receives all three chocolate conditions in a randomized order, with a 7-day washout period between visits. Blood pressure, heart rate, pulse wave velocity, blood glucose, appetite, pain, and calf circumference are measured before and during a 3-hour sitting perio

This study is a randomized controlled trial designed to evaluate the effectiveness of an 8-week tele-rehabilitation program in adults with cystic fibrosis. Cystic fibrosis is a chronic condition that affects the lungs and can lead to reduced muscle mass, physical weakness, frailty, and decreased quality of life. Participants will be randomly assigned to either a tele-rehabilitation group or a usual care group. The tele-rehabilitation program includes supervised exercise sessions conducted remotely three times per week using video communication. The program combines aerobic and resistance training based on established rehabilitation guidelines. The primary aim of the study is to assess the effect of the program

Following a stroke, the function of the distal upper limb, especially hand and finger movements, is often severely compromised, significantly restricting the ability to carry out daily activities. It is estimated that 55-75% of stroke survivors suffer from motor dysfunction, with upper limb impairments affecting up to 85% of them (Tang et al., 2024). Current rehabilitation approaches, while beneficial, often produce limited gains in hand function, particularly in patients with chronic stroke. Virtual reality (VR) training has emerged as a promising tool in neurorehabilitation, providing repetitive, task-specific, and engaging practice environments that can promote motor learning (Cameirão et al., 2012). tDCS has also shown potential to enhance motor recovery when combined with motor practice (Kang et al., 2016). To date, no studies have directly compared the effectiveness of Bi-tDCS with VR for improving upper limb function after stroke.

This randomized controlled trial will evaluate the impact of chrono-nutrition, a dietary approach that aligns meal timing with the body's circadian rhythms, on weight change, metabolic outcomes, appetite, and gut microbiota in post-bariatric surgery patients. A total of 246 adults who underwent sleeve gastrectomy at least six months earlier will be enrolled at King Saud Medical City. Participants will be randomized to receive either standard post-bariatric nutritional care or personalized chrono-nutrition based on individual chronotype. Outcomes include weight change, metabolic biomarkers, dietary behaviors, sleep patterns, and gut microbiota composition. The study aims to determine whether integrating chrono-nutrition into post-bariatric follow-up can enhance metabolic health and improve long-term health.

This study aims to evaluate the upper limb motor recovery using a 3D-printed dynamic orthosis compared to a conventional one as part of a rehabilitation program in individuals with chronic stroke. The main question it seeks to answer: Which type of dynamic splint (3D-printed or traditional), combined with the task-oriented therapy program, leads to greater improvement in affected upper-limb function, patient satisfaction, and usability in stroke patients? Researchers will compare these two types of dynamic splints. Participants will: Receive 20 sessions of task-oriented therapy combined with either a 3D-printed dynamic splint or a traditional dynamic splint. Visit the clinic five times a week for a period of four weeks. Undergo assessments before and after the 4-week program.

Modern lifestyles often involve long periods of sitting, which can increase the risk of heart problems, obesity, and other health issues. Diet also plays a key role in heart health. Coffee and hibiscus tea are two common beverages, but their effects during prolonged sitting are not well understood. This study will examine how drinking coffee versus hibiscus tea affects blood pressure, heart rate, and heart rate variability in men and women during extended periods of sitting. Participants (30 in total: 15 women and 15 men) will take part in a randomized crossover study, meaning each person will try both beverages at different times. Data will be collected using questionnaires, body measurements, and devices to measure heart rate, blood pressure, and heart rate variability. The goal is to better understand how these drinks influence heart health during sedentary behavior.

Cervical degenerative disease (CDD) resulting in myelopathy represents the commonest disease affecting the spinal cord in adults. Cervical radiculopathy can be associated with myelopathy or occurs alone. The treatment frequently requires surgical intervention; which could be done through anterior or posterior cervical spine approach, or a combination. In this study, we aim to evaluate the value of the innovative device (CeLFI; Cervical expanding facet implant), inserted from posterior approach, in widening the neural intervertebral foramina by providing an anterior distraction of the cervical facet joint space (FJS). Therefore, achieving indirect nerve decompression while maintaining cervical alignment and stability. A prospective clinical study of a biomechanically and cadaver-validated device, following the pathway of similarly approved devices. Informed consent will be taken before the participation of every patient. 20 adult patients undergoing posterior surgery for CDD (for radiculopathy or myelopathy); from C2-6, will be included. Clinical evaluation will include pre- and post-operative standard outcome measures including visual analogue score (VAS), Neck disability index (NDI), and Modified Japanese Orthopedic Association score (mJOA). Standard radiologic evaluation will be performed before and after surgery including X-ray, computer tomography scan (CT), and Magnetic resonance imaging (MRI). Interim detailed safety analysis will be conducted after the first 5 cases are performed.

This clinical trial aims to evaluate the effect of different types of tDCS modulation with mCIMT in improving affected upper-limb motor function for stroke patients. The main question it seeks to answer: Which type of tDCS (bi-hemispheric, anodal, or cathodal) combined with the mCIMT program leads to greater improvement in affected upper-limb function in patients with stroke? Researchers will compare these three types of tDCS to a sham tDCS. To see which kind of tDCS protocol combined with the mCIMT program will be more effective in improving affected upper-limb function for stroke patients. Participants will: 1. Participants will receive 12 sessions of mCIMT combined with tDCS or mCIMT alone. 2. Visit the clinic three times a week for four weeks. 3. Participants will do fMRI and TMS before and after the program and three times of assessment before and after two weeks after the program.

This study will investigate whether combining virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.

The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are: * To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients. * To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics. The participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.

Literature suggests that profound hearing-impaired people have poor access to health care directly related to communication difficulties. A lack of knowledge regarding health and healthy dietary patterns has been documented. Several associations between chronic diseases such as obesity, CVD, hyperlipidemia etc., and hearing impairments have been established. There is a gap in the literature for studies that use Saudi-sign language-tailored programs in patient health and nutrition education. This project aims to create a Saudi-sign language general nutritional education program and then test its effectiveness in enhancing the nutritional status and knowledge of Saudis with profound hearing impairments.

Type 1 diabetes mellitus (T1D) is a growing public health concern in Saudi Arabia, ranking ninth globally in T1D incidence and tenth in T1D prevalence in children, and the rates are expected to rise and incur greater healthcare costs. Genetic and immunological factors are believed to play a significant role in disease development, and recent clinical trials have shown promise in delaying or preventing T1D onset in high-risk individuals. Early screening for immunological or genetic markers in children is crucial to identify high-risk individuals and provide early intervention. Last year, the American diabetes association's recommended clinicians to screen first degree relatives of individual with T1D. Unfortunately, Saudi Arabia and other Arab countries lack established T1D screening programs, making early identification and intervention challenging. The benefits of screening include education for symptom awareness, monitoring to track progression to clinical T1D, a five-fold reduction in diabetic ketoacidosis (DKA) at onset, and improved glucose control for the first years following diagnosis. To address this issue, exploring effective and efficient screening methods in identifying high-risk children and the cultural acceptability, feasibility, and barriers to a broader implementation of such screening programs among Saudi families is crucial. Therefore, the investigators aim to conduct a prospective cohort study among young children and adolescents with a family history of T1D (i.e., T1D first-degree relatives). Children 2-18 years old will be screened using a 5 spots filter-dried blood sample for the following: 1. Islet autoantibodies: IAA, GADA, IA-2A, Zn-transporter autoantibodies using the antibody detection by agglutination PCR (ADAP) assay. 2. HLA phenotyping 3. Genetic risk score after the cross-sectional assessment those who are determined to be in stage I, or II of T1D will be offered prospective follow-up for 5 years.

Lifestyle modifications, including dietary changes and increased physical activity, play a crucial role in controlling complications to reduce or eliminate them. As well as controlling disturbances in biochemical markers such as DNAm PhenoAge, and signs of aging such as circulating sclerostin (SOST) and growth differentiation factor 15 (GDF15). This study seeks to address this dilemma by focusing on specific groups of elderly Saudis with prediabetes . Lifestyle changes in elderly Saudis with prediabetes show promise in reducing or eliminating complications. The potential insights derived from this research extend beyond academia, offering tangible benefits for clinical practice and public health The proposed study will be implemented to achieve the following objective: 1. To determine changes in DNAm PhenoAge of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program. 2. To determine changes in other candidate senescence markers such as circulating sclerostin (SOST) and growth differentiation factor 15 (GDF15) of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program.

The global rise in the prevalence of obesity paved the way for the increased prevalence of yet another obesity-related complication significant enough to be considered within the roster of major public health threats: non-alcoholic fatty liver disease (NAFLD). In this follow-up study, the investigators will attempt to decipher the natural history of hepatic steatosis among patients with type 2 diabetes mellitus (T2DM) using state-of-the-art methods in a well-characterized Saudi cohort. The investigators aim also to validate existing biomarkers of disease severity and explore the pathogenesis of progressive disease using metabolic profiling technologies. A total of 1000 adult Saudi patients (males and females) with T2DM will be recruited. Those with co-morbidities, including hepatic decompensation, will be excluded. Participants will be followed three times for a total of 10 years/patient (Year 2, Year 5, and Year 10), and measures such as dietary evaluations, anthropometrics, and urine, stool, and blood examinations will be performed. Patients who develop NAFLD will be noted, and patterns/changes in the metabolic profile will be examined. For this specific grant (the first 2 years of the whole project), the investigators will be able to recruit the study cohort, do the baseline anthropometric, imaging, and biochemical measurements, and report the prevalence of NAFLD among patients with T2DM. This information will be the basis of subsequent follow-up and allow for validating potential diagnostic and prognostic biomarkers. This project will be of high importance at the national level since it will create awareness in the local medical community of the current severity status of NAFLD in the kingdom and will be used as a tool to promote public health awareness in the community.

SLE disease in Saudi Arabia is yet not well defined especially in a population with high consanguinity and high inbreeding coefficient . Up until now, there has been no prospective cohort study for SLE patients in Saudi Arabia. As a result, current published literature is focused on retrospective chart reviews which are subjected to many forms of bias. so the investigator proposed this prospective registry which will follow open cohort study design aiming to provide better understanding of disease presentation, course and outcomes especially if complemented by detailed immunological, molecular, genetic and microbiome data.

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.