Clinical Research Directory

AI-assisted Fall Prevention Through Evidence

The goal of this multi-method study is to investigate how AI-assisted fall-prevention are implemented in routine hospital care what their effects are. The main questions it aims to answer are how these AI systems influence patient safety outcomes, how they affect healthcare professionals work and healthcare resource use, and what factors support or hinder their sustainable integration into hospital environments.

Bedside Bike Early Mobilization Program for Inpatients

Hospital immobility leads to serious complications including muscle loss, weakness, delirium, pressure ulcers, and blood clots. Despite being medically stable, hospitalized patients spend over 90% of their time in bed due to staffing shortages, fall risks, and limited physical therapy availability. Within one week of admission, patients can lose approximately 2% of thigh muscle mass per day, and nearly half develop clinically significant hospital-acquired weakness.The Bedside Bike is a portable, low-resistance exercise device that clamps securely to hospital beds, allowing patients to perform leg and arm cycling exercises safely without leaving their bed. This study will evaluate whether hospitalized patients at Indiana University Health facilities can feasibly and safely use the Bedside Bike to maintain mobility during their hospital stay.This quality improvement study will enroll 80 adult inpatients expected to stay at least 3 days. All participants will receive the Bedside Bike in addition to usual care (standard physical therapy and medical treatment). The study will measure how often patients use the device, whether it is safe (tracking any device-related problems), and whether it may help improve outcomes such as hospital length of stay, functional mobility scores, discharge to home, and rates of hospital-acquired weakness. Participants will have functional assessments at admission and discharge, use the Bedside Bike throughout their hospitalization (targeting at least 15 minutes daily), and be followed for 60 days after discharge to track readmissions, falls, living arrangements, and mortality.

Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project

This Guangzhou-based project uses a randomized controlled trial to test home environment modifications (e.g., anti-slip mats, lighting) for preventing falls among 320 community-dwelling elders. Over 12 months, it assesses effectiveness, cost-efficiency, and scalability, with rigorous quality control and multi-level stakeholder collaboration.

Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults

The long-term goal of this project is to effectively bridge the research-clinic-community gap and to foster partnerships that support the implementation, utilization, and advocacy of evidence-based fall prevention programs in the older adult community. The Otago Exercise Program (OEP) is an evidence-based fall prevention program that has been shown to reduce falls and fall-related injuries among older adults. Traditionally, OEP is delivered in the home by a physical therapist and focuses on muscle strengthening and balance training. Despite its proven effectiveness, adherence and compliance rates have been low. The personnel and resource demands of program delivery, along with challenges in monitoring participant adherence, represent significant barriers to broader implementation. Alternative delivery systems using remote and community-based platforms may help address these limitations. Specific Aim 1: To compare the effectiveness of two delivery modes of the Otago Exercise Program: a remotely delivered, home-based smartphone program and an in-person, community-based program. Specific Aim 2: To examine the feasibility, acceptability, and usability of the Otago Exercise Program delivered through both smartphone-based and in-person formats.

Exercise Program for Deaf Seniors to Increase Their Balance and Fitness

Deaf older adults 60 years and older are enrolled into an 8-week exercise program delivered in American Sign Language. The class meets twice a week, with handout and video homework. Outcome measures are self-reported balance confidence, lower extremity strength, walking and agility, and standing balance. In addition, attendance and keeping up with exercises at home will be tracked.

THE EFFECT OF STANDARD PATIENT AND WEB-BASED SIMULATION ON FALL KNOWLEDGE AND ATTITUDES AMONG NURSING STUDENTS

The most fundamental principle of any healthcare service is "First, do no harm." No one should be harmed in healthcare services. Falls are the most frequently reported and preventable incident among all safety incidents in the hospital environment. However, falls are the most frequently reported incident among all safety incidents. Patient falls are the most common adverse events in hospitals. Patient falls in hospitals cause physiological and psychological harm to patients, affect the timeliness, effectiveness, and efficiency of care, and lead to increases in hospital costs and length of stay. Therefore, preventing falls, which have serious consequences, is of vital importance in terms of patient safety and healthcare quality. Nurses are a group that can sensitively identify and manage issues related to patient safety. Therefore, it is important to identify and reduce the underlying risk factors for falls in patients and to provide appropriate nursing interventions to prevent secondary injuries in patients who have fallen. Simulation is an important part of nursing education because it improves patient care and ensures patient safety. Simulation-based learning provides students with realistic clinical situations, allowing them to practice clinical skills in a safe environment. This enables students to develop their clinical skills, communication, decision-making, and self-efficacy in a risk-free, safe, and structured environment, representing a contemporary teaching approach. Teaching safe patient care during nursing students' education is one of the most fundamental elements of nursing education. Inadequate nursing knowledge and attitudes increase the risk of falls among patients receiving care. Students with insufficient clinical experience are at high risk of making undesirable errors in patient care. It is important to increase nursing students' knowledge and attitudes regarding falls during their education. The standard patient and web-based simulation application offers the closest experience to real clinical situations, providing students with significant potential to become aware of falls they may encounter in practice and prevent potential errors. The increasing importance given to patient safety due to the rising number of fall cases supports the necessity of this research. The aim of this study is to evaluate the effect of standard patient and web-based simulation methods on nursing students' knowledge and attitudes regarding falls.

COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance

The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement improve musculoskeletal health and prevent falls and declining physical performance in the increasing number of older adults in the U.S. with potential for clinical and public health benefits.

Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis (STAR)

People with multiple sclerosis (MS) have a higher fall risk compared to older people and to the general population. A meta-analysis reported that 56% of those with mild to moderate MS, fell at least once during a 3-month period. The risk of falling seems to peak when the walking distance starts to be affected and when walking aids are introduced and the walking distance is as short as 100 m. Previous studies have identified a number of fall risk factors, both relating to MS- symptoms and contextual factors. In a study published in 2025, we reported the complexity of fallsituations and the interaction between triggering factors, contextual factors and activities and circumstances that occurred before the fall incidents . The symptoms when having MS varies between individuals as well as over time. I the planned randomised, controlled multicenter study we move forward, producing individual fallrisk analyses based upon the findings from the study published in 2025, and offer individual strategies. This has not been studied before. All participants will receive general information on how fall risk can be prevented. Those randomised to control group will be offered the intervention after ending of the study. The study will be conducted in two phases starting with an internal pilot study followed by a full scale randomized controlled trial (RCT).

Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults (Otago)

Falls are a major health care problem for seniors. The Otago Exercise Program, which consists of strength and balance training delivered by a physiotherapist, can reduce falls in this population. We will test two methods to deliver the Otago program. These will include a new coaching approach by a physiotherapist with the use of a Fitbit to provide feedback versus the traditional delivery. The degree to which the program is delivered as intended by physiotherapists as well as the number of falls, risk of falling, and participation in walking activities in older adults will be assessed over 24 months. Lastly, we will assess if the coaching approach is a cost-effective option.

Mapping Post-falls Organisational Processes in Care Homes

The aim of this study is to map post-falls management organisational processes for older people in care homes. The main question to answer is 'What post-falls management organisational processes are used for older people in care homes?' Participants (care home and healthcare staff) will complete a one off online national survey about policies and processes relating to falls management in their organisation.

HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)

The focus of this pilot will be on falls and neurocognitive symptoms, and the impact of alcohol, cannabis use, and medications on these outcomes. The rationale is that alcohol use at any level may interact with neurocognitively active medications, alcohol, and cannabis use leading to falls and impaired cognition.

The Geriatric Emergency Department Pharmacologic Harm Prevention Project

The goal of this project is to determine whether pharmacogenomic testing (using participants' DNA) can help optimize medication prescribing and reduce side effects in older adults taking five or more medications. The main questions it aims to answer are: * Can DNA-based prescribing reduce medication-related side effects, especially falls and fall-related injuries? * Does providing pharmacogenomic results to primary care physicians improve medication safety compared with usual care? Researchers will compare two groups: 1. DNA Care Pathway: Physicians receive patients' DNA results to guide prescribing. 2. Emergency Department Care Pathway: Physicians provide usual care; DNA results are shared only after study completion. Participants will: * Provide a cheek swab sample for DNA analysis (1 minute). * Receive monthly follow-up phone calls for 6 months to track falls, injuries, medication changes, and side effects. * Complete a fall and medication calendar. * Allow researchers to review primary care physician medical records for study outcomes. Approximately 1,000 participants will take part, with follow-up lasting about 6-7 months.

Occupation-Based Multicomponent Intervention to Reduce Fall Risk in Older Adults

This study aims to examine the effects of an occupation-based, multicomponent occupational therapy intervention on older adults aged 65 years and above with a history of falls living in the community. The intervention consists of 12 individualized sessions designed around the participants' meaningful occupations. It incorporates balance and gait training, environmental modifications, behavioral strategies, and safety-enhancing activities within a holistic framework. The sample will include 40 older adults who have experienced at least one fall in the past year. Data will be collected using the Canadian Occupational Performance Measure (COPM), Tinetti Balance and Gait Test, Timed Up and Go Test (TUG), and Mini-Mental State Examination (MMSE). Pre- and post-intervention measurements will be compared to evaluate the program's effects on occupational performance, satisfaction, balance, and gait functions. The study is expected to provide valuable evidence on the effectiveness of occupation-based approaches in fall prevention interventions for older adults.

Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement

the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR. the investigator hypothesize that conventional physiotherapy integrated with a fall prevention program is more effective than conventional physiotherapy alone in improving balance and functional ability and preventing the occurrence of falls among elderly following TKR. Study type: The proposed study is a parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial. Participants: Older adults operated for TKR at Al-Razi orthopedic hospital, who met the inclusion criteria.

Action Observation and Exercise for Balance in Older Adults: A Randomized Trial.

The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk.

Incidence and Factors of Functional Decline After Emergency Department Discharge in Older Adults With Falls

The goal of this observational study is to learn about changes in activities of daily living (ADL) in older adults after being discharged from the emergency department (ED) following a fall. The main questions this study aims to answer are: How often do older adults experience a decline in their ability to perform daily activities after being discharged from the ED for a fall? What health or lifestyle factors (such as frailty, medications, physical activity, or fear of falling) are related to this decline? Participants will be 65 years or older, admitted to the ED for a simple fall, and discharged without hospitalization. At the time of their ED visit, participants will be asked questions about their health, medications, activity level, and daily functioning. They will then be contacted online or by phone at 7 days and 30 days after discharge to answer follow-up questions. This study will help identify how common functional decline is after falls in older adults discharged from the ED, and which factors may predict higher risk. These findings could help improve follow-up care and prevention strategies for older patients.

Superiority of Intelligent Video Surveillance + Telealarm Over Telealarm Alone in Elderly People at Risk of Falling

Maintaining the elderly at home and preventing them from falling are major public health issues. The vast majority of elderly people wish to remain at home. The fear of a fall with prolonged standing is a frequent reason for institutionalization. There are few procedures that have been shown to be effective in preventing falls and their complications. Prolonged standing on the floor is a major complication that can lead to multiple events, including death. Tele-alarms are widely used in France and in Europe, but their effectiveness in the event of a fall is poor and their use is restrictive (they require physical and mental capacities to activate). However, elderly people at risk of falling are often frail or dependent, suffering from cognitive disorders and sometimes polymorbid, which explains the large number of failures of tele-alarms. There are other alert systems, notably intelligent video surveillance systems such as the VA2CS. This is a video system placed in the home that analyzes the position of subjects in real time using algorithms based on artificial intelligence. The system works continuously without video capture and sends an alert with a photo if a person is lying down after a fall. The alert is confirmed after an operator has checked the photo capture on a dedicated platform. To date, it has a sensitivity and specificity of over 90% (manufacturer's data not published). Its performance is equivalent to other intelligent video surveillance systems published in the literature. This system is autonomous and does not rely on the abilities of the person at risk of falling. Intelligent video surveillance is an innovative technology which has not yet been evaluated in a geriatric care program, nor compared to a reference or analyzed from a quality of life or medico-economic perspective. The hypothesis of this study is that intelligent video surveillance allows an exhaustive and early detection of the fall with a faster alert enabling to avoid prolonged standing on the ground and its consequences compared to the tele-alarm alone.

Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People

There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. However, the inevitable drug-drug interactions related to polypharmacy and the pharmacokinetic modifications related to old age may lead plasma overdose situations which can potentiate the risk of falls but also aggravate these consequences. The investigators therefore propose a study with the objective of verifying whether the proportion of falls with serious traumatic consequences is more frequent in patients over 75 years old, presenting plasma overdoses of psychoactive drugs (plasma concentrations higher than the usual therapeutic concentrations) in regard to those between therapeutic ranges. The aim of this work is to verify if the falls present more severe characters when the psychoactive drug concentrations are beyond the usual therapeutic ranges.

Steps Against the Burden of Parkinson's Disease - RCT Kiel

Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Treadmill training, augmented by mechanical/virtual-reality triggers, has proven effective in enhancing gait and reducing falls. However, underlying treadmill training mechanisms are unclear. To personalize training, we'll explore how PD patients benefit and transfer effects to daily life. This trial is part of three parallel randomized controlled trials within the Steps Against the Burden of Parkinson's Disease (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004) project, which will perform a pooled analysis across all sites in addition to individual RCT analyses. Each trial adheres to a shared core protocol while allowing for adaptations in the perturbation protocol, ensuring that data can be combined. Importantly, mechanistic findings and outcomes from this specific RCT will be reported independently, but also as part of a pooled analysis. In this trials, PD patients will undergo treadmill training with and without adaptations (perturbations). 12 sessions of treadmill training will be provided, with pre/post assessments and a Follow-up 12±2 weeks following T1 with pre/post assessments and a Follow-up 12±2 weeks following T1 at 8 to 12 weeks after the post assessment. For post treadmill training a phone app will be offered as a home-based speed dependent walk training intervention. This intervention is an App based training for gait adaptability and allows users to set their own training time and pace. It delivers a rhythmic metronomic beat for three different walking speeds, designed to trigger movement and encourage better walking patterns. Gait improvements are expected, driven by sensorimotor integration improving balance control. Biomechanical data analysis will reveal enhanced foot placement control. Neurophysiological changes will be studied through EEG and EMG, aiming to find improved gait stability with reduced EEG beta power and increased EEG-EMG coherence. Gait improvement in the lab might not correlate with daily-life results. Gait self-efficacy could influence transfer, prompting investigation into mechanistic associations with mobility outcomes. Remote digital tools will assess week-long mobility outcomes, employing machine learning to comprehend why some improve both in lab and life, while others don't. This will uncover mechanisms translating treatment effects into real-world outcomes, aiding personalized intervention development.

Effects of an Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall-related Self-efficacy Among Chinese Post-Stroke Individuals

This study is about exploring the effectiveness of individual and family self-management (IFSM) fall prevention programs on balance ability and fall-related self-efficacy in post-stroke people. The main intervention measures were developed based on the risk and protective factors of fall prevention in post-stroke people, including exercise, environment safety, assistant technology, medication review, and safety in daily activities. The intervention was implemented in 10 weeks for both patients and their family members. By mastering these skills, post-stroke people may reduce the number of falls after discharge to home.

Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation.

Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data

The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors.

Real-life Dual-Task Training

Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaningful that there is greater decline in performance of at least one task when comparing single and dual-tasking. Difficulty dual-tasking may actually predict falls in community-dwelling older adults. Dual-task training has been shown to improve cognitive outcomes (attention, memory), motor outcomes (balance, gait), and dual-task performance in older adults; however, most dual-task training involves simulated tasks that do not reflect functional dual tasks in the real world. Greater dual-task improvements could be seen when training functionally specific tasks. One way to increase task specificity is to offer real-life, contextually-relevant, dual-task training embedded in instrumental activities of daily living (IADLs). Limited evidence exists for dual-task training interventions for older adults with T2DM; however there is early evidence of improvements in cognitive and motor effects with simulated dual-task training, which could translate to improved dual-task performance, reduced impact on everyday life, and reduced fall risk. Therefore, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a real-life dual-task training program for older adults at risk to fall.

PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert

Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers (study I). Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it (study II). The remaining nurse aides, registered nurses and managers working in nursing homes in the control group continue with regular care.