Treatment Trials

68 Clinical Trials for Various Conditions

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RECRUITING
Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients
Description

The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.

RECRUITING
Fall Risk Identification and Management for Older Veterans
Description

Falls are a common occurrence among older adults, and Veterans have an even higher risk of falling compared to non-Veterans. These falls often lead to severe health consequences, including traumatic brain injuries, hip fractures, emergency visits, hospitalizations, and even death. It is crucial to prioritize fall prevention in order to reduce injuries and enable older Veterans to age comfortably at home. Although current fall prevention programs in the Veterans Health Administration primarily focus on inpatient care and nursing homes, there is a pressing need to address falls among older Veterans living independently in the community. The proposed VA-specific Fall Risk Identification and Management (FRIM) model aims to proactively prevent falls in older Veterans who receive primary care, effectively reducing the occurrence of adverse health events associated with falls. By placing emphasis on prevention rather than reacting after falls have already happened, this initiative seeks to significantly enhance the overall well-being of older Veterans.

Conditions
RECRUITING
Using Consumer-grade Wearable Devices for Fall Risk Evaluation and Alerts
Description

Creation and use of a smartphone application for older adults to assess the participants' risk of fall. Phase 1: Compare the accuracy and validity of accelerometer and gyroscopic data from a smartphone and gold-standard, wearable sensors gathered during balance and gait activities. Phase 2: Develop a model that integrates wearable sensor data and individual characteristics, such as age, medical conditions, exercises, previous falls, fear of falls, along with gait and balance outcome measurements, to evaluate fall risk in older adults. Phase 3: Integrate the computational model in the design of a mobile app for wearable devices for older adults to self-administer fall risk assessments and provide individualized risk of fall information.

Conditions
RECRUITING
The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category
Description

The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category. Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention. Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention. Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance. Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category.

Conditions
RECRUITING
Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg
Description

Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.

RECRUITING
Fall Risk and Quality of Life: in Individuals With Cancer Treatment Related Peripheral Neuropathy.
Description

The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer and neuropathy from cancer treatments. The investigators are interested to find out if the participant have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. Investigators are also interested to see if the participants have any difficulty with doing two activities at the same time, such as walking and texting.

RECRUITING
Muscle Fatigability and Trip-specific Fall Risk in Adults With Knee Osteoarthritis
Description

The goal of this clinical trial is to learn about how fatigue affects the risk of falling in adults aged 55-70 years with and without knee osteoarthritis. The main questions this trial aims to answer are: * Does fatigue increase the risk of tripping while walking? and * Does fatigue increase the risk of falling in response to a trip while walking? Participants will * Complete questionnaires * Wear a device that measures physical activity for 5-7 days * Complete a 30 minute walk on a treadmill * Complete the following before and after the treadmill walk: * Computer test to measure mental fatigue * Maximal strength testing * Balance test Researchers will compare adults with and without knee osteoarthritis to see if fall risk in adults with knee osteoarthritis is affected more by walking activity compared to adults without knee osteoarthritis.

COMPLETED
Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Description

The goal of this observational study is to examine the associations among fall risk appraisal, body composition, and physical activity in older adults in low-income settings. The main questions it aims to answer are: * What is the feasibility of recruitment (e.g., how many older adults need to be screened to recruit the sample?), especially during the COVID-19 pandemic, and acceptability of technologies and procedures for use among older adults in low-income settings? * What are the the dynamic relationships between fall risk appraisal, body composition, physical activity, and behavioral changes related to fear of falling? Participants will: * complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling. * participate in static and dynamic balance tests, body composition measurement and handgrip strength test. * wear an accelerometer for physical activity assessment for 7 consecutive days.

COMPLETED
Community Exercise for Fall Risk in PD
Description

Parkinson's disease (PD) affects approximately 1 million people in the United States and causes significant fall risks. This study aims to develop a community-based exercise program that reduces falls in persons with PD. By combining individualized balance activities with group boxing training, the study seeks to identify modifiable risk factors, improve balance dysfunction, and reduce falls. The findings will inform clinical practice, offering a community-based exercise model to address the urgent need for effective fall prevention interventions in PD.

RECRUITING
Patient Perspectives of an Automated Falls-Risk Screening and Referral Tool in the Emergency Department (ED)
Description

The purpose of the overall study to evaluate implementation-related outcomes of a falls-risk clinical decision support (CDS) system using patient electronic health records (EHR) data to automatically screen and identify older adult ED patients at high risk of future falls and allowing ED clinicians to place referral orders to the UW Health Mobility and Falls clinic. This CDS tool has already been implemented at the UWHC ED, and will be additionally implemented at The American Center and Swedish American Hospital EDs (all QI initiatives) over the next two years. This study involves engaging a sample of referred patients from each site to gather their perspectives on the delivery of the referral in the ED, their experiences in making and completing appointments at the Falls Clinic (if applicable), and perceived benefits of the intervention overall.

Conditions
RECRUITING
Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention
Description

The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can done at home helps to improve the ability to perform standard physical tasks, confidence in balance, and health-related quality-of-life

RECRUITING
Effectiveness of an Automated Falls-Risk Screening and Referral Tool in the Emergency Department (ED)
Description

The purpose of this retrospective cohort study is to evaluate the effectiveness of an EHR-based clinical decision support system (CDS) for automatically screening older adult ED patients for risk of future falls and providing ED clinicians opportunity to place referrals orders to the UW Health Mobility and Falls Clinic for those at highest risk prior to discharge. This CDS tool has already been implemented at the UW Hospital ED, and as a QI initiative will be implemented in a staged process at two other UW Health-affiliated emergency departments (The American Center and Swedish American Hospital).

Conditions
COMPLETED
Graded Motor Imagery and Fall Risk in Older Adults
Description

To determine if there is any carry over effect of sensation training for the feet, officially called Graded Motor Imagery (GMI), will impact balance and fall risk factors in older individuals. This will be looked at to see if there is a difference in balance and sensation before and right after the training.

COMPLETED
HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults
Description

Older adults often have difficulty performing complex walking tasks leading to increased fall incidence and subsequent injury. Even in the best clinical settings, it may not be possible for patients or clinicians to dedicate the time and financial resources needed to enact lasting improvements. The study will investigate the use of non-invasive brain stimulation and motor imagery practice within participants homes to assess study design feasibility and potential for mobility improvement.

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

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.

UNKNOWN
The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Description

This study has 3 objectives: (1) demonstrate the effectiveness of balance training for people with COPD, (2) determine which patients with COPD respond best to balance training, and (3) calculate clinically meaningful changes in balance for patients with COPD.

COMPLETED
Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety
Description

This is a sub-study for data analysis of data collected as part of the larger randomized controlled trial "Effectiveness and Implementation of mPATH-CRC" (NCT03843957) to determine if self-administered screening with an iPad increases the detection of patients with depression, falls, and intimate partner violence.

Conditions
ACTIVE_NOT_RECRUITING
Wearable Airbag Technology to Mitigate Falls in Individuals With High Fall Risk
Description

The purpose of this study is to evaluate the feasibility and efficacy of a smart airbag system that detects and mitigates fall-related impact in individuals with high fall risk.

COMPLETED
Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk
Description

The goal of this project is to further develop and evaluate a computerized cognitive-training program designed to extend older adults' functional independence and reduce accidental falls (i.e., reduce factors that contribute to fall risk; including cognitive abilities/executive functions). This intervention may benefit a large population of vulnerable older adults with elevated fall risk and lack of long-term viable treatment options.

Conditions
RECRUITING
Reducing Fall Risk With NMES
Description

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.

Conditions
RECRUITING
Effect of NMES on Balance and Fall Risk in Chronic Stroke
Description

The aim of this study is to describe the effect of neuromuscular electrical stimulation (NMES) in the form of functional electrical stimulation (FES) applied to different lower limb muscles on reactive balance and gait performance in stroke participants. Methods: Twenty individuals with chronic stroke will be asked to perform an experimental protocol that includes a postural disturbance in the form of a slip- or trip-like perturbation and a standardized walking test in both laboratory and outdoor environments with and without FES applied to different lower limb muscles of the paretic leg. FES will be applied using an advanced software that is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. This project design aims to examine whether a specific pattern of lower limb muscle stimulation could improve the kinematic and behavioral responses during reactive balance following slip- and trip-like perturbations. Additionally, the project aims to see if the kinematic and spatio-temporal gait parameters can be modified during a standardized walking test under different sensory and environmental conditions.

Conditions
COMPLETED
Boston ARCH 4F Intervention to Reduce Fall Risk in People With HIV and Alcohol Use
Description

This study is being conducted to assess the acceptability and feasibility of a randomized trial of a 10 week virtual intervention to reduce fall risk in people with HIV who consume alcohol. The hypothesis is that this randomized trial of the fall prevention intervention will be found to be feasible and acceptable in this pilot stage. Standardized assessments will be administered in-person at Boston University Medical Campus to assess various domains including fall risk, fear of falling, physical performance measures (such as grip strength, balance, and gait speed), substance use, and other related measures. The intervention has 3 main components: home exercises, virtual group sessions and weekly phone check-ins. Home exercise will be customized to match the current fitness level of participants. Participants will be asked to complete assigned exercises 3 times per week. Additionally, there will be a weekly virtual group session led by an Occupational Therapist trained in group facilitation via Zoom. The virtual group sessions will be used to help answer any questions and lead a discussion around challenges related to falls. Finally, a member of the research team will check-in with participants once per week to answer any remaining questions that participants have, provide individual feedback on exercises, and set up reminders for the upcoming week. Reminders will be tailored to the individual participant's needs to remind the participant to complete the intervention's components.

COMPLETED
Community-based Tai Chi, Balance, and Fall Risk
Description

Aims: Examine the effects of a community Tai Chi program on measures of balance and sensorimotor function. Methods: In a pre-test and post-test design, balance was measured in older adults (N=344; 73.4±7.4 years) with 30-second chair stand, timed-up and go, and 4-stage balance test following a 12-week community-based tai chi intervention. Balance measures and additional sensorimotor measures, including hip abductor electromechanical delay and hip proprioception, were measured in a smaller sample of older adults (n=11; 67.3±3.7 years).

COMPLETED
Merging Attentional Focus and Balance Training to Reduce Fall Risk in Older Adults
Description

Approximately 15 million older adults fall every year in the United States and fall prevention programs have only been moderately successful in arresting fall rates. This proposal uses motor learning principles derived from the attentional focus literature to determine whether training someone where to focus their attention during a balance task enhances balance control and reduces fall risk. Older adults (N=90) who are classified as fallers (one or more falls in the past 12 months) will be recruited. A series of balance control, clinical metrics of fall risk, and patient-reported outcomes will be assessed prior, during, and after a 12-week intervention to examine changes in performance and fall risk. The 12-week intervention will emphasize directing the participants' attention either internally or externally during a series of balance tasks. Empirical evidence and our preliminary data leads us to hypothesize that an external focus of attention training will positively influence balance control. This will be the first study to will examine balance control changes over 12-week balance intervention using an attentional focus paradigm and we will relate the balance control changes to clinical metrics that indicate fall risk and patient-reported outcomes. Further, our proposal includes a novel model of entropy in postural sway, a metric that has been proposed to relate to balance ability, to help explain the hypothesized enhancement in balance. Thus, this proposal will merge motor learning principles with a 12-week balance intervention to determine if fall risk is reduced in older adults. Specific Aim 1 compares balance performance within each trial/session throughout the 12 weeks of balance training to evaluate whether the attentional focus groups (external vs. internal) differ in their motor learning trajectory with respect to the balance task. Specific Aim 2 compares the motor ability outcome measures that relate to fall-risk between the groups (external focus, internal focus, or control) before, during, and after the 12-week balance intervention. Specific Aim 3 compares the patient-reported outcome measures of fear of falling, functional health and well-being, and fear of injury from movement between the groups (external focus, internal focus, or control) before, during, and after the 12-week balance intervention.

Conditions
COMPLETED
Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function
Description

Neurological impairment such as stroke and aging is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative (Yoga, Tai-chi) therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke and the elderly population is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming based therapy to improve overall physical function of community-dwelling individuals with neurological impairments and the elderly, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain pilot data on compliance and efficacy as well as performing power analysis and sample size calculation for developing it into a randomized controlled trial for extramural funding purposes. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals and the elderly population.

RECRUITING
Perturbation Training for Fall-risk Reduction Among Stroke Survivors
Description

The long-term objective of this research is to develop an efficacious training paradigm to enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare cost. The Centers for Disease Control and Prevention estimates the direct medical cost for fall related injuries to be $34 billion annually. Forty percent to 70% of community-dwelling stroke survivors experience detrimental falls each year and tend to have 1.5 to 4 times higher risk of hip fracture than their healthy counterparts; with only less than 40% of those individuals regaining independent mobility. Falls, thus not only affect activities of daily living but also reduce mobility, increase risk of second stroke and mortality. Despite potential financial and functional implications of falls in this population, health-care personnel are limited in their ability to develop and validate interventions to reduce fall-risk for them. Further emphasis is placed on locomotor training with focus on enhancing paretic limb function. The project design consists of a randomized controlled trial to examine the ability of chronic stroke survivors to acquire, generalize and retain adaptations to slip-perturbation training for not only mitigating fall risk but also improving walking function. It also explores translation of this paradigm to the sub-acute population. The paradigm is novel in that it targets contributions of the paretic vs. non-paretic limbs on fall-risk through a bilateral training paradigm that involves training the non-paretic side first and then paretic to facilitate acquisition of fall-prevention skills on the paretic side, which may otherwise take longer to acquire training effects. The longer-term benefits of such perturbation training, targeting both limbs for reducing falls will be assessed not only in the laboratory but also in real life via wearable sensors, along with improved community walking function. The hypothesis of this study if supported by the results will provide an evidence-supported training protocol to reduce the fall-risk not only in people living with hemiparetic stroke but also among survivors of other acquired unilateral cortical lesions.

Conditions
COMPLETED
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study
Description

Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study

UNKNOWN
Malnutrition's Role in Fall Risk
Description

Falls and falls related injuries are considered one of the most adverse events that a patient can experience. Several assessment instruments to assess and mitigate risks for falls have been developed. However, these instruments have not addressed nutritional risk factors. Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the hospital setting is a significant concern and may play a role as a fall risk factor. The World Health Organization (WHO) maintains a global anemia database. WHO has identified iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including industrialized nations. The consensus statement of the Academy of Nutrition and Dietetics / American Society of Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of inadequate intake along with a multitude of other factors. Weight loss occurs at multiple points along this continuum. this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss and degree of Hgb decline may be fall risk factors.

COMPLETED
Optimizing Fall-risk Prediction in Older Adults With Cancer
Description

To establish the optimal strategy of fall-risk assessment to predict falls in older adults receiving cancer therapy.

Conditions
UNKNOWN
Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease
Description

This research study is being done to determine whether treatment with L- Dihydroxyphenylserine (L-DOPS) versus placebo (an inactive substance that looks like study drug) in addition to other Parkinson Disease (PD) drugs will improve balance, walking, and reduce risk of falls and/or severity of falls in PD subjects. The study is also being done to determine the effectiveness, safety, and tolerability of L-DOPS, and whether it will decrease Freezing of Gait (FOG), improve apathy (generalized disinterest) or show a relationship between apathy and slowed movement and fall risk.