Clinical Research Directory

Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults

The goal of this clinical trial is to learn if an active educational intervention (using interactive and active methods of teaching) works better than the traditional lecture teaching to reduce concerns of falling, falls and other health problems among older adults. The main questions it aims to answer are: Does having more dynamic interactive educational interventions can performed better than using just traditional lectures? Are these interventions able to reduce concerns of falling, fears and other outcomes among older adults? Participants will: Receive one of the interventions (active/interactive or traditional lecture) Answer self-report questionnaires related to concerns of falls and falls Perform some fall-related tests Be followed for 3 and 6 months

Online Watch-Summarize-Question-Ask Method in Falls Education for Nursing Students

This randomized controlled study will evaluate the effectiveness of an online Watch-Summarize-Question-Ask (WSQA) learning method on nursing students' knowledge, skills, attitudes, and behaviors related to patient fall prevention and management. Sixty-six nursing students will be randomly assigned to intervention and control groups. Both groups will receive standard patient safety education, while the intervention group will additionally participate in an online, evidence-based fall prevention training program structured according to the WSQA method, including video-based learning, summarization, question generation, and interactive discussions. Outcomes will be assessed using validated instruments measuring fall management knowledge, self-efficacy, attitudes toward fall prevention, care planning performance, and student satisfaction. The study aims to determine the effectiveness of an innovative educational approach to improve fall prevention competencies and enhance the quality and safety of nursing care.

Evaluating Methods to Replicate Stumbles and Slips During Walking

This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations. Subjects will be divided into two groups: prosthetic users and able-bodied individuals. Each group will undergo a series of tests where controlled perturbations are applied using up to three methodologies with the number depending on factors such as time and fatigue. These methodologies may include mechanical, visual, or auditory perturbations designed to mimic unexpected obstacles or changes in terrain.

Modifying the Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department for Telehealth

The goal of this clinical trial is to determine the feasibility of eGAPcare, a telehealth modification of the GAPcare fall prevention intervention, in older adults in a community emergency department. The main questions it aims to answer are: * Can telehealth physical therapy and pharmacy consultations be conducted in a community emergency department? * Does the telehealth modification of GAPcare decrease recurrent falls at 6 months? Participants will * Receive telehealth physical therapy and pharmacy consultation while in the emergency department * Participate in follow-up visits over the phone for 6 months following the initial emergency department visit * Complete study questionnaires delivered by study staff.

Strong Evidence: Digitally Delivered Exercise in Older Adults

The investigators have successfully completed a pilot project focused on feasibility and user acceptability of a digitally delivered program for fall prevention in older adults. It was well received among a population of lower and moderate risk individuals. The investigators propose to extend this research by repeating the training program with the inclusion of a wait list control group. Group A (immediate intervention) will start their initial 12 week exercise program (Intensive Exercise) within 4 weeks of baseline (BL) measurement (as a cohort). This will be followed by an optional additional 12 week exercise program (Maintenance Exercise 2) that participants who complete at least 10 of the Exercise 1 classes will be invited to join. This will be followed by a 12 week wash out period. Measurements will occur each 12 weeks (BL, 12 week post randomization, 24 week post randomization, 36 week post randomization) Group B (waitlist control) will start with a 12 week life as normal period that is concurrent with Group A's intensive Exercise. They will start Intensive Exercise when Group A is doing Maintenance exercise. They will be invited to Maintenance Exercise while Group A is doing washout. They will not have a washout period. Measurements will occur at the same period(s) as Group A (i.e. all participants measured during the same time period). The intervention will be identical to what was offered in the past, and measurements will be very similar (removing those that did not show change with intervention or were deemed too difficult for participants).

COMMUNITY-BASED POWER TRAINING IN FALLER AND NON-FALLER OLDER ADULTS: A FEASIBILITY AND FALL RISK STUDY.

Aging leads to substantial alterations in the nervous and skeletal muscle systems that ultimately lead to a reduction in "neural drive" and motor performance. While maximal strength starts declining as early as 50 years of age, aging brings even greater reductions in rate of force development and muscle power, that has been shown to be a stronger predictor of functional independence and balance impairments. Falls are a major health concern as one third of adults over 65 years loses balance and falls every year, and based on a published report, the estimated health care costs associated with falls in the European Union is €25 billion. The ability to recover balance declines with aging, where older individuals often recover balance with a greater number of balance recovery steps and non-optimal stepping strategies. In addition, older adults have more difficulty recovering balance in the medio-lateral direction. The hip abductors are fundamental in controlling the motion of the body centre of mass in this direction during weight transfers of standing, stepping, and walking. Furthermore, these muscles appear to be more susceptible to age-related composition and performance declines than other muscles of the lower limbs, especially in individuals at a higher risk for falls. Unfortunately, common balance interventions, such as, functional balance training, Tai-Chi, or dance, have a very limited capacity to reduce the risk of falls in older adults. Interestingly, resistance training is relatively better than the mentioned interventions at reducing this problem. This may come about through mitigating the agerelated neuromuscular performance deficits. However, traditional resistance training lacks the emphasis in high velocity movements required for adequate fall prevention protective stepping strategies. Muscle power training is a safe and effective alternative to traditional resistance training. By emphasizing in maximum speed of execution, its results are often better than with traditional resistance training, especially in functional outcomes, with the potential to enhance balance recovery. However, there is little and inconsistent evidence on the optimal exercise parameters (such as velocity) for prevention of falls. Community-based multi-component exercise programs are often used to promote health and functional benefits in the older adult population. These programs not only have a positive impact in a larger number of communitydwelling individuals, but can also lead to significant improvements. Nonetheless, these programs limited in reducing the risk for falls. Considering the robust effects of muscle power training in the older population, it is conceivable that a multi-component community-based exercise intervention, that focuses on developing muscle power and reduce fall risk, can improve the older individuals' ability to recover balance and consequently, bring greater benefits to the older adult community. However, there is no information on the feasibility of conducting an exercise program to develop muscle power and reduce fall risk in a community-based setting. Furthermore, it is generally unknown if such an exercise intervention can improve function, balance, and reduce the occurrence of falls in older adults especially, among those that have fallen in the past- which are the most relevant target population for both clinical studies and practice.

Technology Supported Improvement, Management and Prevention of Accidental Falls in Hospitals

The student will observe fall prevention systems in practice in 2 different hospitals considering how fall prevention technology influences staff behaviour and patients safety in the context of accidental falls in hospital. Accidental falls in hospital are rare but can be life changing for those that suffer them as they are often frail patients who are already vulnerable. Current research shows little improvement with any interventions tested which leaves patient facing clinicians with few resources to assist in the prevention of falls. The investigator believes this is because the measure of accidental falls in hospital is not sensitive enough to calibrate for the different contexts in which patients fall. The student would posit that it is the context that is most influential and addressing the context may lead to improved measures so progress can be made in finding solutions.

Evaluating Stumble Recovery Functions of Prosthetic Knees

The study aims to conduct a formative evaluation, along with verification, validation, and comparative analysis of the stumble recovery function in prosthetic devices by collecting relevant clinical data. The study will involve participants who are current users of lower-limb prosthetics. Utilizing a robust study design, data will be gathered in both controlled setting and real-world to thoroughly assess the performance, safety, and user satisfaction of the function. The scientific value of this research lies in its potential to enhance prosthetic technology, support evidence-based clinical practices, and ultimately improve the quality of life for users by reducing fall risks and increasing mobility confidence.

Pilot Feasibility Study of a Fall Prevention Exercise Programme for Community-dwelling Older Adults in Nanchang, China

The goal of this pilot clinical trial is to evaluate the feasibility of a fall prevention exercise programme for older adults living in urban communities in China. The study will also gather preliminary data on whether the programme can improve adherence to exercise and reduce falls. The main questions it aims to answer are: * Is the Safe \& Joyful Walk programme feasible and acceptable for older adults in urban China? * Does the programme help participants stick to regular exercise? * Does the programme show early signs of improving balance, walking speed, and reducing falls? Researchers will compare the Safe \& Joyful Walk programme to Tai Chi to see which approach may better support exercise adherence and fall prevention. Participants will: * Attend 24 instructor-led group exercise sessions over 12 weeks * Complete additional unsupervised home-based exercise practices during the same 12-week intervention period * Continue unsupervised exercises during a 24-week follow-up period to assess long-term adherence * Complete surveys, interviews, and physical tests at baseline, 12 weeks, and 36 weeks * Record their exercise and any falls in diaries and calendars

Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program.

Study Description: The investigators propose to extend earlier research conducted during a feasibility study (Strong Foundations 1.0) by enrolling participants who have a greater risk for falling (x4 cohorts of up to 15 individuals) and from a lower socio-economic status (x4 cohorts of up to 15 individuals), and by collecting high quality laboratory based measures of balance, posture, and strength to better determine the effectiveness of the program and its suitability for widespread deployment. Additionally, the investigators hope to showcase it is feasible to sustain programmatic gains with ongoing digitally delivered content by combining cohorts into a larger group that continues to practice the foundational exercises taught during the 12-week initial program.

Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities

The Home Hazard Removal Program (HARP) is an effective fall prevention intervention program which targets home hazard identification/removal. In this study the investigators will examine the effectiveness and implementation potential of HARP, adapted for PwD. Investigators will conduct a pilot randomized control trial (RCT) to test the implementation, cost, and preliminary efficacy of an adapted version of HARP for community-dwelling PwD. The single-blinded feasibility RCT will randomize 40 participants to treatment (adapted HARP) and 40 to a waitlist control group. Data on specific types of fall hazards and resulting home modifications as well as falls and fall-related injuries (collected monthly over 12 months) and fear of falling (collected at baseline and 12 months) will inform the preliminary efficacy of adapted HARP among PwD. To ensure usefulness, relevance, and broad dissemination of findings, the investigators will adopt a "designing for implementation and dissemination" approach. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework will guide intervention adaptation, trial design, and future implementation. The Practical Robust Implementation and Sustainability Model (PRISM) guides study development by identifying multi-level contextual factors hypothesized to affect the RE-AIM outcomes.

Evaluation of a Foot Health Program Incorporating Minimalist Footwear on Fall Risk Factors in Older People Living in Senior Nursing Homes: a Pilot Study.

Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations. The main objective of this study is to evaluate the evolution of mobility in older people living in nursing homes, following 12 foot health workshops, carried out by a health professional, including the wearing of minimalist shoes.

Aging and Task-specific Training to Reduce Falls

The goal of this clinical trial is to examine the effects of a novel task-specific balance training for reducing environmental falls in community ambulatory older adults who are at-risk of falling. The main questions it aims to answer are: * Does task-specific balance training improve the ability to prevent falling when unexpected perturbations such as slips and trips occur, and/or improve balance control during self-initiated movements? * Does task-specific balance training reduce real-life falls for 18 months after training? Researchers will compare task-specific balance training with conventional balance training and treadmill perturbation-based training to examine how this novel intervention compares to established interventions for improving balance. Participants who participate in the study will be asked to do the following: * Complete a pre-training assessment of their balance control, and then be randomized to one of three training groups: 1) task-specific balance training, 2) treadmill perturbation-based training, and 3) conventional balance training * Complete their assigned training protocol for 8 weeks (2x per week for a total of 16 sessions) * Complete 2 post-training assessments of their balance control, the first being completed immediately after the training is completed, and the second being completed 18 months after the training is completed * Wear a physical activity monitor for 18 months after completing the intervention to monitor their real life falls.

Steady Stride Fall Prevention Protocol vs Standard of Care

Falls are the leading cause of preventable morbidity and mortality in community dwelling older US adults (65 years old and older) . This is a research study to evaluate the comparative effectiveness of the structured physiatry-based Steady Strides Fall Prevention Protocol compared to the standard of care treatment provided by primary care providers in preventing falls in community-dwelling older adults.

The Effects of Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults

1. Develop an evidence-based dual-task intervention programme incorporating gamification for fall risk reduction in older adults. 2. Examine the effects of the gamified dual-task intervention on fall risk in older adults. 3. Elucidate the underlying mechanisms of the optimal gamified dual-task intervention programme in reducing falls in older adults.

THE EFFECTS OF A PROPRIOCEPTION-ENHANCING ASSISTIVE ORTHOSIS ON BALANCE AND JOINT SENSE IN GERIATRIC PATIENTS

This study investigates the effects of a proprioception-enhancing assistive orthosis on balance and joint sense in geriatric patients with age-related diseases. The study uses wearable devices that deliver vibration stimuli to improve proprioceptive feedback. A total of 20 participants will be enrolled in a 24-month, IRB-approved trial at Seoul National University Hospital. The study assesses functional balance and joint position sense before and after using the device.

EXpress Prevent Rural oldEr Adults' fallS, fractureS and Dependency (EXPRESS)

Falls are the leading cause of injury-related death among individuals aged 65 and above in China. The incidence of falls shows a significant urban-rural disparity in China, with rural areas experiencing a markedly higher rate than urban regions. However, a systematic fall prevention strategy tailored to the needs of older people in rural China has not yet been established. The EXPRESS study is a multicenter, cluster-randomized controlled trial designed to explore the effectiveness and health economic evaluation of an AI-assisted, village doctors and express services-involved, personalized fall screening and prevention strategy based on multidimensional risk profiling in reducing the incidence of falls and fall-related injuries among older people in rural China. A total of 1,881 older individuals from 16 villages across four provinces in China (with four villages per province) will be recruited. These 16 rural areas will be randomly assigned to either the intervention group or the control group. The intervention group will receive the AI-assisted, village doctors and express services-involved personalized fall prevention strategy based on multidimensional fall risk screening and assessment, while the control group will follow routine primary health management practices. The intervention period will last for one year, with randomization taking place after the baseline survey. The primary outcomes are the incidence of falls and fall-related injuries (including falls resulting in hospitalization and fractures, etc). Secondary outcomes include activity of daily living, quality of life, fall-related health literacy, depressive symptoms, cognitive function, dementia, physical function and performance, incidence of chronic non-communicable diseases, frailty, and sleep quality.

Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients

The goal of this clinical trial is to determine the effectiveness of perturbation-based balance training (PBT) in preventing unrecovered falls among geriatric patients aged ≥70 years with a prospective fall risk of ≥40%. The study will also assess the safety and feasibility of PBT. The main research questions are: A total of 396 participants will receive 9 training sessions of either PBT or conventional treadmill training and will attend an assessment before and after the intervention, as well as 6 and 12 months follow up. Falls will be documented throughout the entire study period using calendars, telephone interviews, and proxy information. The primary outcome, unrecovered falls, will be recorded after the end of the intervention until 12 months follow up.

Validation of the Self-Assessment for Falls in the Elderly (SAFE) Questionnaire to Assess the Risk of Falls in People Aged 60 or Over.

This single-centre, cross-sectional diagnostic study will determine whether the new self-completed Self-Assessment for Falls in the Elderly (SAFE) questionnaire can classify fall-risk level (low, moderate, high) in adults ≥ 60 years as accurately as the current clinician-administered international algorithm that mixes yes/no questions with physical tests; to do so, about 300 participants will (1) sign consent, (2) answer the 5-minute SAFE, and (3) undergo guideline assessment and tests by a clinician in the same visit, after which researchers will compare SAFE and clinician results for sensitivity, specificity, and predictive values, examine agreement and correlations, and give immediate risk-based prevention advice: * Eligibility: men or women ≥ 60 y, stable walking/balance ≥ 1 month, able to read French and perform brief tests; legal guardianship or refusal excludes. * Participant tasks: complete SAFE; perform Timed Up-and-Go, 4 m gait speed, Five-Times-Sit-to-Stand and Short Physical Performance Battery (SPPB) under supervision * Benefits/Risks: instant personalised fall-risk feedback; SAFE is risk-free and physical tests carry only minimal supervised exertion. Falls are a leading cause of injury and death in older adults, and current assessments require trained staff; if SAFE proves equivalent, it could enable large-scale, low-cost self-screening and support future digital monitoring tools for fall prevention.

The Effect of Home Based Fall Prevention Program on Older Adults at High Risk of Falling

Fall prevention programs that implement and evaluate fall rates, balance status, accidents related to falls and hospital admissions, exercise status, muscle strength, fear of falling, and quality of life can be effective interventions for healthy aging by minimizing the risk of falls in elderly individuals. In this doctoral dissertation study, it was aimed to evaluate the effect of a nurse-led home-based fall prevention program on fall rate, balance level, fall risk score, fear of falling, number of hospital admissions due to falls, quality of life, and in-home safety conditions in older adults with high fall risk.

Effect of Otago Exercise Program in Comparison With Dual Task Training on Balance and Postural Control in Elderly Population

Balance and postural control are major concerns in reduction of risk of fall among older adults. Otago Exercise Program and dual task training program are commonly used approaches to improve balance, functional mobility and postural control. However, limited studies have compared the efficacy of Otago Exercise Program and dual task training program in improving balance and functional mobility. One-third to one-half of the population over age 60 reports injuries due to fall because of the high incidence of balance and mobility disorders in older adults, interventions are necessary that optimize the performance of balance- and mobility-related activities among older adults. The aim of the current study to find out better intervention which will benefit the clinicians and physiotherapists in clinical decision making of managing the geriatric population, suffering fear of fall, going to effect on their daily livings, with evidence.

Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes

The DIACTIVE study is a randomized controlled trial with a 5- year follow-up designed to evaluate the impact of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older on the short and longer term. Diabetes significantly increases risks of falls, fractures, and cardiovascular disease, yet these areas remain underexplored in clinical research. This trial addresses these gaps with a novel, multidimensional approach. Participants undergo extensive baseline assessments, including fall risk stratification, bone mineral density measurements via DXA scans, neuropathy evaluations, and cardiovascular profiling. Based on these evaluations, participants are allocated to risk-based intervention arms. The study's centerpiece is the RYMA and ADL exercise program, a tailored cognitive-motor training regimen integrating strength, balance, and executive function exercises with music-based coordination tasks. Pharmacological treatments for osteoporosis and optimization of cardiovascular risk profiles (e.g., SGLT2 inhibitors, GLP-1 agonists) are also incorporated. Primary outcomes focus on reducing fall rates by at least 30%, improving bone density, mitigating fracture risks, enhancing nerve function, and lowering cardiovascular event rates. Secondary endpoints explore mechanisms underlying fall reduction, quality of life improvements, and adherence to interventions. Advanced methodologies such as gait analysis, seismocardiography, and magnetic resonance imaging (MRI) provide detailed insights into the intervention's effects. Follow-ups at 26 weeks, 52 weeks, 2 years, and 5 years ensure long-term efficacy evaluation. This trial is conducted at Steno Diabetes Center North and involves interdisciplinary collaboration. By addressing key complications of diabetes through integrated care, the study aims to improve patient outcomes and inform future healthcare strategies for older people with diabetes.

Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults

APN-FIT is a hybrid type 1 clinical trial comparing the effect of an APN delivered fall prevention programme with standard care in non-frail patients. All participants will receive a full geriatric assessment at enrolment and, on a voluntary basis, physical activity programmes during the 12-month period. Falls occurring during the study will be recorded at 2, 4, 6, 8, 10 and 12 months after enrolment. An ancillary study will specifically examine implementation outcomes of the tested intervention.

Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.