Clinical Research Directory

Tai Chi Intervention for Geriatric Pain Syndrome

Accumulating evidence supports that more pain, whether measured by number of pain sites or pain severity, is associated with poorer cognitive function and mobility, and fall risk in older persons. Tai Chi which holistically integrates physical and cognitive functions offers the possibility not only of alleviating pain but also improving attention and mobility in the many older adults who have chronic multisite pain. This proposed full-size randomized controlled Tai Chi trial is a direct extension of the investigators' previous work examining chronic pain, attention demands, mobility and falls in the older population, and is built on the investigators' National Institute on Aging-supported Tai Chi feasibility and acceptability pilot studies among older adults with multisite pain and risk for falls. The goal of this single-blinded randomized controlled trial is to examine the effects of a 24-week Tai Chi intervention on chronic pain, cognition, mobility, fear of falling, and fall rate in older adults with multisite pain and at risk for falls. The results of this study will provide a foundation to establish the clinical significance of Tai Chi in the management of chronic multisite pain and to explore the mechanisms through which Tai Chi improves chronic pain symptoms and lowers fall rate in at-risk older adults.

Targeting the Hip Abductors to Reduce Falls in Older Veterans Through A Virtual Multimodal Balance Intervention

Falls are a major health concern and a leading cause of injurious death and non-fatal injuries in older Veterans who are at greater risk for falls than non-Veterans. This in-person exercise intervention targeting changes in the hip muscles, known to play a major role in balance, has been effective at reducing falls in older Veterans. Gerofit is a VA best practice health promotion program that demonstrates good success in engaging Veterans in exercise. However, the role of Gerofit in fall prevention is unknown. Some Veterans may require additional training prior to participation in Gerofit to maximize the benefits of Gerofit. The proposed intervention will use novel home-based methods of exercise to improve hip muscles prior to participating in Gerofit. The goal of this study is to evaluate if a live virtual home-based multimodal balance intervention done prior to Gerofit compared to Gerofit alone will have a greater benefit on fall risk reduction and improved muscle and mobility function.

VIVI-OLIVE: Multicomponent Exercise and Extra Virgin Olive Oil in Older Adults at High Risk of Falls

VIVI-OLIVE is a multicenter randomized clinical trial evaluating whether a 24-month intervention combining an individualized multicomponent exercise program (VIVIFRAIL), Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) can improve physical function and reduce fall risk in adults aged 75 years or older at high risk of falls. Participants will be randomly assigned to either the VIVI-OLIVE intervention or a control group following the VIVIFRAIL multicomponent exercise program. The main outcome is change in usual gait speed, which is an indicator of physical function and fall risk in older adults. Other outcomes include intrinsic capacity, functional independence, quality of life, muscle strength and sarcopenia, muscle characteristics, fear of falling, Mediterranean diet adherence, falls and fall-related consequences, and adherence to the study interventions.

Healthcare Services for Older People Who Have Fallen With Potential Head Injury

Every year, one in three older people (\>65 years old) experience a fall. Older people may have long-term health conditions and take medications that can increase their risk of bleeding (blood thinners). The UK national guidelines recommend that older people who are on blood thinning medications should have a CT head scan considered due to concerns of a brain bleed if they have hit their head after a fall. Many older people are therefore brought into hospital for assessment. However, the risk of bleeding in the brain is very low especially if older people do not have any symptoms such as loss of consciousness, weakness, headaches or vomiting. Some people could experience long waits in the emergency department or end up being admitted to hospital unnecessarily. This could worsen mobility, cause confusion, pressure sores or infections in older people. More importantly, older people should have a comprehensive falls assessment to reduce their risk of future falls and have their medications reviewed after experiencing a fall. These assessments could potentially take place in their own homes if they prefer, rather than in hospital. Yet, current healthcare services outside the hospital setting may not be set up to manage an older person after fall. Using an online survey, the investigators want to understand how current healthcare services in the Hampshire and Isle of Wight (HIOW) region work to look after older people who have had a fall. The study will focus particularly on older people taking blood thinning medications who may have a head injury but do not have any symptoms. The investigators will ask NHS workers what their role is, where they work and what they do when assessing an older person who has fallen if there is a concern about head injury. The survey will also ask participants to describe what challenges they may face, and if they have any suggestions to improve the care for older people. This study will help the investigators understand what services are available in our current healthcare system for older people on blood thinning medications who have fallen and may have a head injury. The investigators hope that the results will help improve how healthcare services can work together with older people and their closed ones to provide care based on what matters most to them in their preferred place of care. This could reduce unnecessary use of emergency services and hospital admissions for older people.

Relationship Between Gastrocnemius and Soleus Muscle Thickness Assessed by Ultrasound and Balance and Fear of Falling in Hemiplegic Patients

Structural and functional changes occurring in the lower extremity muscles of hemiplegic stroke patients play a decisive role in gait ability, balance impairment, and fall risk. In this context, the relationship between muscle architecture parameters such as the thickness of the gastrocnemius and soleus muscles and functional performance is being investigated. Ultrasonography is a reliable and accessible method for the non-invasive assessment of muscle thickness. Yakut et al. (2024) reported that in acute stroke patients, particularly the thickness and cross-sectional area of the soleus muscle were significantly associated with the Berg Balance Scale, Single-Leg Stance Test, and Timed Up and Go Test. In the same study, it was also shown that the thickness of the gastrocnemius muscle on the non-paretic side was related to balance. Onat et al. (2022) demonstrated correlations between lower extremity muscle architecture and measures such as the Timed Up and Go Test, Fugl-Meyer Lower Extremity Assessment, and Functional Independence Measure, emphasizing that the gastrocnemius and soleus muscles play a determining role in motor and functional level. Suh et al. (2022) reported that trunk muscle thickness was significantly associated with the Berg Balance Scale, Functional Ambulation Scale, and Functional Reach Test. In this study, gastrocnemius and soleus muscle thickness will be evaluated using ultrasonography in subacute and chronic stroke patients, and their relationship with balance (Berg Balance Scale), mobility (Timed Up and Go Test and Functional Ambulation Scale), and fear of falling (Falls Efficacy Scale International) will be investigated. The study aims to provide original contributions to the literature by revealing the interaction between muscle architecture and both physical and psychosocial outcomes, and to support the development of targeted rehabilitation strategies for individuals at high risk of falling.

Preventing Falls in Older Adults With Cognitive Frailty

The Problem: The proposed trial will address the problem of how to effectively prevent subsequent falls in community-dwelling cognitively frail older adults with a history of falls. Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can a home-based exercise program with behavioural change techniques significantly reduce falls vs. health education (i.e., control; CON)?

Effects of Tele Rehabilitation vs Onsite Rehabilitation on Balance, Mobility, and Risk of Fall Among Geriatric Population With Knee Osteoarthritis

This randomized controlled trial aims to determine the effects of telerehabilitation versus onsite rehabilitation on balance, mobility, and risk of fall among geriatric patients with knee osteoarthritis (KOA). Knee osteoarthritis is a common musculoskeletal condition in older adults that is associated with pain, impaired balance, reduced mobility, and an increased risk of falls. Although onsite rehabilitation is effective, many elderly patients face barriers to accessing physiotherapy services because of transportation difficulties, physical limitations, and geographical distance. Telerehabilitation has emerged as an alternative approach that allows patients to receive supervised rehabilitation remotely using smartphone-based communication. In this study, eligible participants will be randomly assigned to either a telerehabilitation group or an onsite rehabilitation group. Both groups will receive the same balance and mobility exercise program for six weeks, with four sessions per week. Outcomes including balance, mobility, and risk of fall will be assessed at baseline, week 3, and week 6 to compare the effectiveness of the two rehabilitation approaches.

Falls In Spanish People With Intellectual Disabilities: Risk Factors And Predictive Equation. Falls.Di Study

This multicenter study aims to understand the specific risk factors for falls in Spanish people with intellectual disabilities in order to design an instrument to assess the risk of future falls in this population. To this end, a prospective cohort study will be conducted in a sample of people with intellectual disabilities who meet predefined inclusion criteria from the Fundación Hospitalarias España centers that care for people with intellectual disabilities. Participants' medical records will be reviewed for sociodemographic variables and associated comorbidities, and gait and balance will be assessed to identify potential risk factors. The number of falls experienced by participants will be monitored for 12 months. After the observation period, a statistical analysis will be performed to identify the main risk factors in the sample. These factors will be used to model a mathematical equation predicting the number of future falls.

Reducing Fall Risk With NMES

Falls are dangerous leading to injuries, hospital admissions and even death. Fall prevention is a priority but effective programs only reduce falls by 30%. Weak hip muscles may be one reasons individuals experience a loss of balance. However individuals who have weak hip muscles may be unable to exercise at sufficient intensities to improve their hip muscle strength. The purpose of this study is to utilize a common physical therapy method, neuromuscular electrical stimulation (NMES), on the hip muscles to improve hip muscle strength and improve balance. The new program focuses on using NMES during a resistance training program along with exercise to improve standing balance, walking and stepping over objects. This study will test the additive effect of NMES applied to the hip muscles during a balance and strengthening program to improve balance and mobility, and ultimately reduce the risk of falls in older Veterans at high risk for falls.

Women's Health Initiative Strong and Healthy Study

The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to \~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise \& Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.

Action Falls for Domiciliary Care

Action Falls is a programme that helps older adults avoid falls and injuries. It finds out why someone might fall and suggests ways to help, like checking their medication and encouraging them to stay active. It was created to try and prevent falls in care homes. It includes training for care home staff, a manual, and a checklist of what to look out for and what to do. Home care providers, local care groups, and older adults who live in the community think Action Falls could be useful too, to help reduce the number of falls in older adults who live at home. The investigators have identified that the programme could be particularly useful for older people who are supported by home care services. The goal of this project is to develop ways to deliver and keep the programme running for older people supported by home care services. A future study will then try it out and see it helps people manage falls in home care. The first part aims to plan and make changes to the current Action Falls programme to make sure it is suitable for use in home care settings. The investigators will do this by * observing what happens on home care visits * asking people who are supported by and who deliver home care how the programme needs to be changed. In a future study the investigators will then deliver the programme across home care in Nottinghamshire and Lincolnshire and evaluate how well it has worked. The study will focus on coastal and rural areas.

How's Your Balance?

The goals of this observational study are to investigate the following: * If there is a relationship between prior falls, single leg stance time, and plantar cutaneous sensitivity as measured by monofilaments. * Plantar sensitivity across a broad range of ages. * Self-reported physical function related to balance and mobility using the PROMIS® PROWalk™ questionnaire and balance confidence using the Activities-specific Balance Confidence Scale-6 (ABC-6). Participants will answer questions about themselves and their balance and falls. Their plantar (bottom of their feet) sensation will also be tested using monofilaments. And they will stand on a force plate with their eyes open and closed in dual and single leg stances for up to 30 seconds.

Prevalence of Sarcopenia-Promoting Medicines in Patients With Sarcopenia and Falls

Sarcopenia, characterised by the loss of muscle mass and function, is a common condition among the elderly and is often associated with increased risk of falls. Certain medications, such as glucocorticoids, statins, and some antipsychotics, may exacerbate sarcopenia, leading to a higher incidence of falls. This study aims to explore the prevalence of such medicines in patients diagnosed with sarcopenia who have experienced falls. Understanding the impact of these medications on sarcopenia and fall risk can inform clinical guidelines and improve patient outcomes.

Personalized Rehabilitation Program for Elderly Patients That Fall

The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death. The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

SAFER Karachi - A Fall Prevention Intervention

The goal of this pilot study is to evaluate the feasibility, acceptability, and short-term effects of a culturally adapted and strengthened fall prevention program in older adults aged 60 years and above living in urban Karachi, Pakistan. The study aims to understand whether a structured, community-based intervention can improve mobility, confidence, and overall well-being, while reducing the risk of falls. The main questions it aims to answer are: 1. Is the adapted and strengthened fall prevention program feasible and acceptable for older adults in Karachi? 2. Does participation in the program improve mobility, balance, fall-related self-efficacy, and emotional well-being among participants? Participants will: 1. Take part in a 7-week group-based fall prevention program that includes strength and balance exercises, home safety education, medication awareness, and behavioural strategies 2. Receive a follow-up home visit to reinforce safety practices and environmental modifications 3. Attend a booster session after 3 months to support continued engagement 4. Complete assessments at baseline and follow-up, including mobility, cognitive function, quality of life, and emotional well-being 5. Maintain monthly fall logs to report any fall incidents during the study period

Falls Validation Study

Each year, one in three adults over the age of 65 has a fall. These falls lead to half a million Canadian emergency department patient visits annually and falls in older adults account for more than 3% of all emergency department visits. A rapid, simple bedside test (known as a decision rule) to guide emergency physicians on when older adults should have a brain scan to diagnose traumatic brain bleeding was created. This decision rule will be checked to see if it works well in guiding who needs a brain scan.

Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop

This study aims to determine if combining the treatments of transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES) will better help persons with stroke who have difficulty lifting their toes. As part of the treatment, subjects will receive electrical stimulation through pads on their scalp (similar to what one may have received in physical therapy previously to an arm or leg). This protocol is called transcranial direct current stimulation (tDCS). Subjects will also receive electrical stimulation through pads on their leg. This is called functional electrical stimulation (FES). During treatment sessions, subjects will also perform leg activity/strengthening exercises. The aim is to evaluate whether combining FES and tDCS within a PT session would reduce foot drop as indicated by improvements in the amount of toe clearance and ankle motion persons with stroke.

Vision Screening in Hospitals for Older Adults Following a Fall

Aims This study aims to improve the way vision is checked and sight loss treated in older adults (65 years or older), who attend hospital following a fall. Background Falling is common in older adults. As the number of older people grows, the number of falls is expected to increase as well. Falling can affect a person's life in several ways: it can lead to pain, injuries, difficulty doing normal daily activities, weaker muscles, feeling isolated, losing independence and confidence, living in fear of falling, depression, difficulty in recovering from illnesses, developing other health problems more easily and a higher risk of death. Falls are a major health problem for the public and the United Kingdom (UK) spends more than £2 billion per year on caring for older adults who fall. Problems with eyesight are also more common in older age and can have a similar effect on a person's independence, happiness and almost doubles their chances of falling. Sight loss in older age that is linked to falling is often treatable. UK guidelines have been made to help prevent falls. These guidelines recommend checking for and treating sight loss in all older adults who attend hospital following a fall. However, this is only being done in a small number of hospitals. The reasons for this need to be investigated, in order to encourage and make it easier for health professionals to follow these guidelines. Research has also shown that older adults, may be less likely to get their eyes tested regularly and attend hospital eye appointments. There are many reasons for this and vision screening whilst the patient is already receiving care in hospital, may be a good opportunity to address these issues. The views of the public are important for developing screening services that they understand and meets their needs. This study will gather the views of older people and their carers on hospital vision screening after a fall and the importance of looking after their eyes. This study aims to improve the way vision is checked in older adults who attend hospital following a fall. This will help to identify and treat sight loss that may contribute to repeated falling. The study will combine the views of older adults and health professionals, to ensure that changes made meet patients' needs and are sustainable. Design and methods This study will have three parts: 1. Focus groups asking health professionals about checking vision in patients who have fallen. 2. Focus groups asking patients who have fallen and their carers about looking after their eyes. 3. Development of a way of checking vision and treating sight loss in older adults who attend hospital following a fall.

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.

Health Promotion With Targeted Exercise Intervention for Decreasing Fall Risk and Inactivity in Aging Veterans With Obesity and Signs of Sarcopenia

Falls are a major health risk for older Veterans, especially those with both obesity and low muscle mass or strength (sarcopenia), which together increase the chances of falling and losing independence. Many older Veterans have difficulty staying active and often lack information about how to safely exercise. While current guidelines focus mostly on weight loss, losing weight alone can weaken muscles and bones, which may actually raise the risk of falls and injuries. This study is testing the benefits of a virtual group exercise program combined with health education. The goal is to find out if exercise combined with health education is better at lowering fall risk and improving daily activity than health education alone for Veterans with obesity and signs of sarcopenia.

Potential of Interface Care Models to Deliver More Appropriate Care to Patients With Acute Medical Illness

Every country in the world is experiencing growth in both the size and the proportion of older persons. As a result of the changes, the profile and needs of people with medical illnesses have evolved. How care is delivered to patients has to keep pace with these changes, or patients will experience poor care at high cost and not have their needs met. A new model of care has emerged to meet these challenges: Acute Medical Unit. Despite considerable investment and popularity of this model, questions remain: (i) Who benefits most from this care model? (ii) How may these models be most effectively implemented for the best results? (iii) How effective are these models? Singapore is well-placed to answer these questions with its national healthcare system and excellent research institutions. The investigators plan to study how effective the model is by comparing patients with similar profiles exposed to both these care models compared to how hospital care is usually provided, looking for four differences: (i) how long patients stay in hospital, (ii) how often they use the emergency department (iii) quality of health (iv) cost. Additionally, the investigators seek to characterise patterns of health needs for this group of patients.

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

Fall Frequency and Factors Affecting Dynamic Balance in Patients With Myotonic Dystrophy Type 1

This cross-sectional observational study aims to determine the frequency of falls in patients with myotonic dystrophy type 1 and to identify factors affecting dynamic balance. The study will also evaluate fear of falling, selected lower extremity muscle strength, and the relationship between muscle strength and fall frequency. The findings may contribute to a better understanding of fall risk and balance impairment in patients with myotonic dystrophy type 1.

The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults

This study examines the relationship between self-awareness and the risk of falls during walking in older adults and rehabilitation patients. Falls are a major health concern among older adults worldwide. Many studies have shown that executive functions, such as attention and problem-solving, are related to fall risk; however, little is known about the role of self-awareness-the ability to recognize one's own strengths, limitations, and errors-in predicting falls. In this study, approximately 100 participants (adults aged 60-85 years) will be recruited from both a rehabilitation day center and community settings. Participants will complete cognitive tests, self-awareness questionnaires, and walking assessments using wearable sensors. Walking will be tested both at a normal pace and while performing a secondary task (dual-task walking). The results will help clarify whether reduced self-awareness is an independent risk factor for falls. Findings may improve fall-prevention strategies in both rehabilitation and community settings. The study protocol has been reviewed and approved by the Faculty Ethics Committee, University of Haifa, and the Helsinki Committee of Clalit Health Services.