Clinical Research Directory

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

Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)

Chronic musculoskeletal pain is common in older adults and is associated with reduced mobility, loss of function, poorer quality of life, fear of movement, fear of falling and a higher risk of falls. Exercise programmes are effective in preventing falls, but very few programmes combine fall-prevention exercise with pain self-management, including pain science education, for older people who live in the community and have both chronic pain and an increased risk of falling. The goal of this pilot randomised controlled feasibility trial is to find out whether it is feasible, acceptable and safe to deliver a 12-week supervised group programme (MovePainFall) that combines multicomponent exercise with pain science and fall-prevention education, compared with a control group that maintains usual activities, in community-dwelling adults aged 65 years or over with chronic musculoskeletal pain (lasting 3 months or more). The main questions it aims to answer are: * Is it feasible to recruit, randomise, retain and engage participants (recruitment rate, eligibility, adherence, retention) and is the programme safe and acceptable? * What are the preliminary effects of the programme on mobility, balance, lower-limb strength, dual-task performance, pain intensity and interference, fear of falling, fear of movement and quality of life? Researchers will compare the MovePainFall group with the control group to estimate feasibility parameters and preliminary effect sizes that will inform the design and sample size of a future full-scale randomised controlled trial. Participants in the MovePainFall group will: * attend three supervised 60-minute group exercise sessions per week for 12 weeks (warm-up, strength and power, challenging balance, motor-cognitive dual-task training, functional gait and daily-living tasks, relaxation); * attend one additional 30-45-minute group education session per week on pain neuroscience, pain self-management and fall prevention. Participants in the control group will maintain their usual activities and routine health care and may be invited to attend the programme after the post-intervention assessment (waiting list). All participants will be assessed by blinded assessors before randomisation and after the 12-week intervention period.

Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall

Falls are one of the most common reasons older adults visit the emergency department. In many older patients, a fall that looks "mechanical" is actually caused by an underlying medical problem such as syncope, heart disease, dehydration or blood clots, and the history is often unreliable. This single-center prospective study will evaluate whether a structured whole-body point-of-care ultrasound (POCUS) examination performed at the bedside changes how emergency physicians manage patients aged 65 years and older who come to the emergency department after a ground-level fall. The main question is how often POCUS findings change the physician's working diagnosis, consultation requests, additional tests, procedures, or admission/discharge decisions. Patients will also be followed for one week for death and repeat emergency department visits.

Feasibility of High-intensity Functional Exercise With Simultaneous Cognitive Challenge for Older People With Falls Risk

This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims: 1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences. 2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences. The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.

Home-Based Exercise Program After Community Balance Training for Parkinson's Disease

This study tested whether a home-based exercise program helps older adults with Parkinson's disease keep the improvements they gain from a community balance program. Participants lived in small towns and rural communities in Oklahoma, where access to movement disorder specialists is limited. All participants first took part in a three-month community-based recreational therapy balance program. At the end of those three months, participants were randomly assigned to one of two groups. One group continued with a home-based program for twelve weeks, which included an exercise manual, instructional videos, and a weekly telephone call from a researcher. The other group received general wellness guidance without follow-up contact. Participants were assessed three times: before the community program began, at three months, and at six months. The assessments measured walking speed, stride length, and cadence; postural stability; concern about falling; anxiety and depression; social connectedness; and quality of life. The purpose of the study was to learn whether continued support at home helps people hold onto the gains they make in a community program, and how quickly those gains are lost without that support.

Effect of Otago vs. Sensorimotor Training on Balance and Fall Risk in People With Diabetes

The purpose of this study is to compare the effects of the Otago Exercise Program versus Sensorimotor Training on dynamic postural stability and risk of fall in patients with type 2 diabetes mellitus. Participants will be randomly assigned into two equal intervention groups. One group will receive the Otago Exercise Program, while the other group will receive Sensorimotor Training. Both groups will participate in their respective exercise protocols for 8 weeks. Dynamic postural stability and the risk of falling will be assessed before and after the intervention period using standardized physical therapy evaluation tools.

Optimal Intensity of Reactive Balance Training for Healthy Older Adults

Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.

A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders

This study evaluates a manualized recreational therapy balance program for older adults with Parkinson's disease and movement disorders who live in small cities and rural areas of Oklahoma, where access to movement disorder specialists is limited. Twenty-four older adults with Parkinson's disease and movement disorders will be randomly assigned to one of two groups of 12. One group will attend the balance program continuously for 24 weeks. The other group will attend the program for 12 weeks and will then be observed for 12 weeks without the program. All sessions are led by a Certified Therapeutic Recreation Specialist and last about 50 minutes once a week. Participants will be assessed three times: before the program begins, at three months, and at six months. The assessments measure gait velocity and stride length, postural stability, fall-related confidence, anxiety and depression, and social connectedness. The purpose of the study is to learn how long a community balance program needs to continue for older adults to keep the gains they make, and how quickly those gains decline when the program ends.

Comparative Effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients With Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) is a common complication of prolonged hyperglycemia that damages peripheral nerves, leading to impaired sensory function, increased fall risk, and reduced quality of life. Balance training has shown promising effects in improving postural stability and reducing fall risk in individuals with DPN by engaging visual, vestibular, and proprioceptive systems and promoting central nervous system adaptation. This randomized controlled trial aims to compare the effects of Reactive Balance Training (RBT) and Task-Oriented Training (TOT) on postural stability in patients with DPN. The study will be a single-blinded, two-group randomized controlled trial conducted over one year at Foundation University College of Physical Therapy. A sample of 36 participants will be recruited through convenience sampling and randomly allocated into two groups using the coin-toss method. Ethical approval will be obtained from the FUSH ERC, and written informed consent will be obtained after explaining the study procedures, risks, and benefits. Postural stability will be assessed using the Posture Assessment Checklist, Mini-BESTest, Functional Reach Test (FRT), and Timed Up and Go (TUG). Group A will receive RBT, while Group B will receive TOT. Each session will last 30-40 minutes, including a 5-7-minute warm-up, 20-30 minutes of group-specific intervention, and a 5-minute cool-down. Participants will receive 60-second rest intervals after every three sets or 8-10 repetitions. The intervention will continue for six weeks, with three sessions per week, totaling 18 sessions. Assessments will be conducted at baseline, at week 3, and post-intervention at week 6 using the same outcome measures.

Polymodal Fall Prediction in Healthy Older Adults: Clinical, Laboratory, and Blood-Based Biomarkers

The goal of this observational study is to identify clinical, laboratory, and biological markers associated with past (and future falls) in healthy older adults aged 65 years and over. The main question it aims to answer is: Which clinical, functional, laboratory, and blood-based markers distinguish older adults who have fallen at least once during the previous 12 months from those who have not? Researchers will compare older adults with a history of falls with similar older adults without a history of falls. One hundred healthy older adults aged 65 and over, including both fallers and non-fallers, will be recruited for the study. Participants will complete questionnaires and undergo cognitive and physical tests, physical activity and sleep monitoring, gait, balance, muscle, sensory and vestibular assessments, brain and muscle imaging, and blood sampling. Blood samples will be used to study proteins and genetic variants that may be associated with falls. Participants will then be followed for one year using a smartphone-based application to report falls. The study is based on the hypothesis that a history of falling in an otherwise healthy older adult may be associated with subtle clinical, functional, and biological differences compared with a similar older adult without a history of falls. The findings may support the future development of more accurate and scalable tools for early fall-risk detection and targeted fall-prevention strategies. No direct therapeutic benefit is expected from participation.

Pragmatic Trial to Increase Quality of Care in State Veterans Homes

Background: State Veterans Home nursing homes (SVHs) care for 51% of all Veterans receiving VA-funded nursing home care. SVHs cost VA $1.2 billion yearly in per diem payments. This critical system provides care to a population of over 20,000 vulnerable Veterans annually but has been little researched and is in urgent need of attention. In some SVHs, the COVID-19 pandemic has resulted in large numbers of preventable illnesses, hospitalizations, and even deaths. Congress, the Government Accountability Office, and the Secretary have all called for greater VA involvement in this system that lacks a national quality improvement infrastructure and lags behind VA on many quality measures, including falls. This study addresses SVHs' need to reduce high fall rates-55% of residents experience at least one fall per quarter-by implementing an effective, evidence-based program known as LOCK. In LOCK, staff (1) "Learn from bright spots" (focus on evidence of positive change); (2) "Observe" (collect data through systematic observation); (3) "Collaborate in huddles" (conduct frontline staff huddles); and (4) "Keep it bite-size" (limit activities to 5-15 minutes). The program avoids reliance on existing quality improvement infrastructures, can be easily integrated into frontline staff routines, and has demonstrated success in improving clinical outcomes, including reductions in falls. Significance: This study provides the following. (1) Timely, evidence-based research support to improve care for SVHs' vulnerable population of aging Veterans. (2) Explicit integration of frontline staff expertise, ensuring interventions are practicable and successful. (3) Direct alignment with high-reliability principles-such as sensitivity to operations and deference to expertise-helping extend VA's high-reliability focus to SVHs. Innovation and Impact: This study contributes the following. (1) Advances the science of how to intervene in settings that do not have a strong, centralized quality improvement focus through rigorous investigation of how and why an intervention works in SVHs. (2) Investigates sustainment of the investigators' intervention-the extent to which it becomes part of usual care-for up to 12 months after completion of each step of the investigators' wedge-based design. (3) Provides timely, systematic investigation of a new area for VA research, gathering information on VA researcher-SVH partnerships to support future collaborations. Specific Aims: Aim 1: Investigate the effectiveness of the LOCK program at improving the investigators' primary outcome of any resident fall. This study will also investigate other resident clinical outcomes (mobility, medication changes, restraint and alarm use) and work-process outcomes for staff (job satisfaction, work engagement, burnout). This study will use both primary and secondary data collection. Aim 2: Evaluate the LOCK program's implementation. This study will use the replicating effective programs framework and multi-modal implementation facilitation strategies to implement the program. This study will use mixed methods to evaluate the program's reach, adoption, and implementation. Aim 3: Assess the extent of program sustainment. Mixed methods will enable examination of intervention sustainment at 3, 6, and 12 months post intervention and sustainment variability among sites. Methodology: This is a 4-year hybrid (Type 2) effectiveness-implementation study. It uses a pragmatic stepped-wedge randomized trial design and employs relational coordination theory and the RE-AIM framework to guide implementation and evaluation. Next Steps: This study (1) directly improves care for aging Veterans, (2) advances understanding of how to intervene in settings lacking quality improvement infrastructure, and (3) contributes knowledge about intervention sustainment. This study also addresses VA's Research Lifecycle stages of (a) scale up and spread and (b) sustainment. Findings may help improve care in other settings (e.g., inpatient mental health and domiciliary programs).

The Effects of Light-Targeted Balance Training on Balance, Functional Performance, and Fear of Falling in Individuals With a History of Falls

In recent years, exercise programs based on visual stimuli have been reported to improve balance and motor control . However, studies investigating the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls are limited. The aim of this study is to determine the effects of light-targeted balance training on balance, functional performance, and fear of falling in individuals with a history of falls. In addition, the study aims to investigate whether this training method provides additional benefits compared with traditional balance training. The findings of this study are expected to contribute to the development of rehabilitation programs aimed at preventing falls.

Land vs. Water Exercises on Performance and Swimming Behavior in Older Adults

This study aims to investigate the effects of an 8-week combined land and aquatic exercise program (conducted 3 days per week) on physical performance, recreational swimming behaviors, and water-related risk perceptions in older adults. Physical performance is evaluated using handgrip strength and the 30-second chair sit-up test (30CST), while swimming behaviors and water-related risk perceptions are assessed via structured questionnaires.

Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology

This study evaluates whether a drug-free, non-invasive haptic patch (LIBERTY Patch) affects fall-risk classification and balance/mobility confidence in adults ages 55 to 85. Approximately 150 participants are assigned to wear either the active LIBERTY Patch or a visually identical sham patch daily for 7 days. Balance and mobility are assessed using the FallSkip wearable device and a Falls Efficacy Scale questionnaire at baseline and again after 7 days. Neither participants nor investigators know which patch is assigned during the study period, though this can be unblinded in an emergency.

Multicomponent Versus Balance Exercise for Older Adults With Recurrent Falls

To compare the short-term effects and 6-month durability of supervised multicomponent exercise, balance exercise alone, and fall-prevention education on balance, strength, walking performance, and health-related quality of life in older adults with recurrent falls.

tDCS in Elderly Fallers Study

The objective of this study is to determine if a four-week, 20-session intervention of transcranial direct current stimulation (tDCS), as compared to sham intervention, improves dual task standing and walking performance (Aim 1), as well as other physical (Aim 2) and cognitive (Aim 3) factors on the causal pathway to falls, in older adults who report two or more falls within the past year and fear of falling again in the future, yet who do not have any acute or over neurological or musculoskeletal condition. Primary endpoints will include the "dual task" costs to gait speed when walking and postural sway speed when standing, as induced by performing a serial subtraction cognitive task (i.e., \[(speeddual task - speedsingle task) / speedsingle task) X 100\] (Aim 1), the Short Physical Performance Battery (Aim 2), and the Trail Making Test (Part B minus Part A) (AIM 3). Secondary endpoints will include the dual task cost to serial subtraction performance, additional gait and balance outcomes derived from the dual task paradigm, the Timed Up-and-Go, fear of falling, habitual physical activity, and performance within a battery of neuropsychological tests focused on global cognitive function, attention, verbal fluency and memory.

Training Improves Balance Control

The purpose of this study was to evaluate the effect of a group-based functional and specific balance training program on balance function in healthy older adults. It is commonly considered difficult to improve balance function in healthy older adults. The program included dual-task exercises; physical training exercises and a cognitive task (e.g. reading or reciting a story) performed simultaneously, as well as perturbation exercises, where balance is challenged in unexpected ways. The investigators hypothesized that following the proposed training, older adults would improve their speed of taking a step in both single and dual task conditions, refine their ability to control balance when standing still and improve their self-reported physical function.

Impact of Primary Nursing on Nursing-sensitive Outcomes in Inpatients Units: a Multicentre Pre-Post Study

The aim of this quasi-experimental before-after study is to evaluate whether the implementation of the Primary Nursing (PN) pattern of care improves nursing-sensitive outcomes in adult inpatients and nurse-related outcomes across hospital wards in Northern Italy. The main questions it aims to answer are: 1. What is the impact of the PN on inpatients' nursing-sensitive outcomes, including healthcare-associated infections, falls, pressure injuries, functional status, and patient satisfaction? 2. What is the impact of the PN on nurse-related outcomes, including burnout, missed nursing care, job satisfaction, and intention to leave? This study follows a multicentre, uncontrolled before-after design: in the pre-intervention phase, wards operated according to their existing nursing care models (functional or team nursing); this was followed by the implementation of the PN across all participating wards. The PN assigns each patient to a single reference nurse who is responsible for planning, delivering, and evaluating nursing care throughout the entire hospital stay. In the primary nurse's absence, an associate nurse ensures continuity by following the individualised care plan.

Tai Chi Intervention for Balance Function in Older Adults: Predictive and Modifying Roles of Circadian Age

This study investigates the effects of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Participants are randomly assigned to either a Tai Chi exercise group or a health education control group. The primary outcome is balance function measured by the Berg Balance Scale. Secondary outcomes include physical function, psychological well-being, cognitive function, and sleep quality. The study also explores the predictive and modifying roles of baseline circadian age on intervention outcomes.

Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls

The goal of this study is to conduct a randomized pilot multi-arm clinical trial comparing a standard course of physical therapist provided pelvic floor muscle training (PFMT) to pharmacologic therapy for the treatment of urgency urinary incontinence (UUI) or Overactive Bladder (OAB) in older women at high risk of falling. The central hypotheses for this project are i) a randomized pilot multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling is feasible; and ii) treatment approach can influence both UI and fall related outcomes in this patient population. The main questions it aims to answer are: 1) Is a multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling feasible? and 2) How does treatment approach influence both OAB and fall related outcomes in this patient population? Women (16 per arm) 60 years and older with UUI or OAB who screen positive for high fall risk will be randomized to one of three standard of care treatment arms and followed for six months. The three treatment arms are i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the outpatient physical therapy clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride. Researchers will compare study feasibility and OAB symptom related outcomes across the three groups to see if a larger clinical trial is warranted.

Virtual Reality for Walking and Balance in Older Adults

Falls are common in older adults due to aging-related problems with walking (gait) and balance. Virtual Reality (VR) is a new technology that creates interactive video game-like exercises. This study aims to see if VR training works better than traditional physical therapy exercises for improving walking and balance in adults aged 60 years and older who live in the community. Half of the 36 participants will use a VR headset to play movement games, while the other half will do standard exercises like tandem walking. We will measure their walking speed, step length, and balance before and after 4-6 weeks of training.

Functional Constipation and Fall-Related Outcomes in Older Adults

This retrospective cross-sectional observational study aims to examine the relationship between Rome IV functional constipation and fall history, functional capacity, and physical activity in older adults. The study will use routinely recorded clinical data from older adults aged 65 to 80 years who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center between April 2024 and April 2026. No new intervention, treatment, exercise program, drug, or device will be applied as part of this study. Functional constipation will be evaluated using bowel habit data recorded in patient files and classified according to the Rome IV criteria. Fall history within the last 12 months will be obtained from routine clinical records. Functional capacity will be assessed using recorded results from the 6-Minute Walk Test and the Five Times Sit-to-Stand Test. Physical activity level will be evaluated using available International Physical Activity Questionnaire data. The study will include data from 208 eligible older adults. The main purpose is to determine whether older adults with Rome IV functional constipation differ from those without functional constipation in terms of fall history, walking capacity, lower extremity functional performance, and physical activity level. The findings may help clarify whether functional constipation in older adults is associated not only with bowel habits but also with broader geriatric and rehabilitation-related outcomes.

Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal Women

Postmenopausal women suffer from a series of negative health factors, such as decreased bone and muscle mass and physical performance, increasing the risk of falls and decreasing quality of life. Therefore, intervention strategies aimed at mitigating these factors are essential. A technique that has been studied and can reverse these factors is whole-body vibration (WBV), however studies present contradictory results and the main confounding factor appears to be related to the type of vibration (synchronous or side-alternating). Therefore, the primary objective of this project is to verify the effects of 12 months of whole-body vibration on different devices on bone mineral density measurements in postmenopausal women. As a secondary objective, the effects on muscle mass, physical performance, quality of life and falls will be verified. 127 postmenopausal women will participate in the study and will be randomized to: triplanar vibration (synchronous); side-alternating vibration; or false vibration. The interventions will last 12 months and will occur three times a week on non-consecutive days. The following assessments will be carried out at baseline, 6-months and 12-months: bone mineral density and muscle mass by DXA equipment, muscle thickness by ultrasound, peak torque of the knee extensor and flexor muscles by an isokinetic dynamometer, hand grip, balance static postural and vertical jump on a force platform, dynamic balance using the Timed Up and Go test, SPPB battery, fear (FES-I) and incidence of falls and quality of life (SF-36).

Use of the KASPARD System for Fall Prevention in Nursing Homes

Falls are a frequent cause of admission to nursing homes \[2\]. It is also the most frequently reported adverse event in these institutions. The prevention of falls in EHPAD must mobilise several levers of action and involve all staff. It must be included in the establishment's project in the same way as the policy on the proper use of restraints \[21\]. Home automation and new technologies can contribute to the prevention of falls and their consequences. Most of the existing solutions on the market are either fall detection solutions based on a watch or pendant or rise detection solutions based on a sub-mattress or floor mat. All of these solutions work with a contact and often require a daily set-up or check by the care teams. But the real challenge today for new technologies is to prevent falls in the elderly, by directly addressing the risk factors. KASPARD is a non-contact (remote sensors) and non-intrusive (no video image, it uses point cloud technology) solution for detecting falls, excessive wandering and nocturnal activities in a nursing home. The information is transmitted securely via the wifi network to a mobile phone (or TSI/DECT) and to a computer. The KASPARD solution, which is already on the market (non-medical CE marking), is used in several EHPADs in Belgium and France. It is not a medical device. To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data). We wish to verify the effectiveness of the KASPARD technology for the prevention of falls in EHPAD, suggested for the moment by an observational study, with the help of a multi-centre clinical study