38 Clinical Trials for Various Conditions
Compared to non-Veterans, Veterans demonstrate an increased risk for obesity and multimorbidity. Thus, interventions to improve overall health are warranted in this population. Healthy diets that include fruits and vegetables are linked to a reduced risk of chronic disease including mobility disability, and are associated with higher muscle mass, strength and physical performance potentially slowing further disability progression later in life. The investigators will determine if a three-month virtual group nutrition intervention paired with produce delivery and virtual teaching kitchen cooking demonstrations tailored for older Veterans with impaired mobility will improve diet, health-related quality of life and muscle strength.
The purpose of this project is to examine the effects of virtual reality greenspace exposure on physiological and affective acute stress responses among adults with mobility impairments.
The investigators propose a pilot randomized trial to gather preliminary data to test the hypothesis that Fisetin will reduce abundance of senescent cells in blood, skeletal muscle, and both subcutaneous and inter muscular adipose tissue and improve 6-minute walk distance in 34 people with peripheral artery disease (PAD). the investigators will determine whether greater declines in abundance of cells with senescent markers are associated with greater improvement in 6-minute walk distance in people with peripheral artery disease. In exploratory analyses, the investigators will assess whether Fisetin reduces interleukin-6 (IL-6) and novel senescent markers in adipose tissue, muscle, and/or blood.
The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are: * Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine? * Is the combined treatment associated with better outcomes than the medication (dalfampridine) on its own? * How do the individual treatments (dalfampridine, physical therapy) alone compare to each other? Participants with MS-related mobility deficits will: * Receive 6 weeks of dalfampridine treatment to assess the effects of this treatment. * After stopping the medication for 2 weeks, the investigators will re-evaluate walking, then randomly assign individuals to a 6-week physical therapy program. * Half of the participants will receive physical therapy while resuming dalfampridine treatment. The other half of the participants will receive physical therapy without resuming the medication. Researchers will compare the combination treatment group (medication plus physical therapy) to the physical therapy only group to see if the combined treatment improves walking-related function. Approximately 3 months after finishing the physical therapy program, participants will undergo a final evaluation to see if the treatment effects have been maintained.
The purpose of this study is to investigate whether Lofstrand or axillary crutches are better suited to treat mobility impairments and improve physical activity levels in rural, resource-limited, settings like the Northern Region of Malawi. To do this, we are proposing the implementation of a randomized controlled trial (RCT) to measure and compare the physical activity and satisfaction of mobility aid recipients sorted into two groups - one receiving a set of Lofstrand crutches (Group 1) and the other a set of axillary crutches (Group 2). Changes in physical activity, disability, and life satisfaction levels will measured with a follow-up data collection period conducted one year after the distribution of the devices.
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.
The purpose of this study is to determine if a newly designed DVD program performs better than standard, printed quit-smoking materials to help smokers who have mobility limitations (e.g., use a cane, wheelchair, braces, crutches, prosthesis) to quit smoking.
The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.
The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (but do not have a mobility impairment) with several single-case studio involving individuals who have a visual and mobility impairment. Our long-term objective is to provide independent mobility to veterans with mobility and sensory impairments.
30 Veterans who are full-time wheelchair users will use personalized modular cushions for two weeks each. Personalized cushions will be created using a cushion fitting process the investigators have already developed and tested. Microenvironmental conditions will be monitored during use. A cost analysis will ensure the customized modular cushion applies value-driven principles. User satisfaction will be measured along with the effects on daily function, skin status and seated tissue health.
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. The Mu rhythm is a naturally occuring wave produced by the brain. This research project will determine how to best train subjects to use the Mu rhythm for computer control.
Moderate (50-69%) asymptomatic carotid artery stenosis (ACAS) is an important and under-appreciated contributor to balance and mobility dysfunction. This is significant because declines in balance and mobility are a significant predictor of falls, disability, loss of independence, and death in older adults. Further, falls and fall-related injuries in older adults cost approximately 50 billion dollars annually in the United States, and are the leading cause of adverse events reported by the Veterans Health Administration. This proposal seeks to: 1) investigate the impact of a supervised aerobic and challenging balance exercise program on balance and mobility function in patients with moderate ACAS; and 2) elucidate whether these changes are related to changes in cerebral perfusion. With 830,000 Veterans estimated to have moderate ACAS and at risk for balance and mobility dysfunction and increased falls, the findings from this study could have significant impacts on the clinical management, quality of life, and functional independence of Veterans with moderate ACAS.
The aims of this study are to determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among patients who have undergone a mastectomy or other breast surgery compared to a control group receiving global relaxation massages.
The Mindfulness, Nutrition and Exercise to Optimize Resilience (MENTOR) program is offered through the National Center on Health, Physical Activity and Disability (NCHPAD). NCHPAD is funded by the Centers for Disease Control and Prevention (CDC), is a public health practice that offers health promotion programs and resources to people with mobility disabilities. The purpose of this project is to provide a free-of-charge wellness program designed to improve health and wellness for people with mobility and physical disability living in the United States.
Although dysphagia is a known complication of cardiac surgery, risk factors and sensitive bedside clinical markers of dysphagia have not yet been identified. This longitudinal study will enroll 380 cardiac surgical patients and identify contributing risk factors of incident cases of dysphagia and identify sensitive bedside markers of dysphagia. Statistical modeling will produce two pragmatic clinical tools - a risk prediction model and a beside screening tool to improve care models.
Approximately 1 in 10 mid-life (age 35-64) Americans have mobility impairing disabilities. People with mobility impairing disabilities are defined using the World Health Organization criteria: community living adults with mobility impairment (e.g., amputation, spinal cord injury). Women with mobility impairing disabilities often struggle with stress, abdominal fat (measured as waist circumference), lack of muscle tissue (measured as handgrip strength) and high cardiometabolic risk. This study investigates the usefulness, acceptability, and effectiveness of two strategies to reduce stress, improve health habits, reduce abdominal fat and increase muscle tissue in mid-life women with mobility impairments. These strategies involve either gentle stretching and strengthening exercises or watching informative videos.
The purpose of this project is to test feasibility of an online platform that delivers virtual exercise programs for individuals with physical disabilities.
The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing throacic surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.
An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates arm and leg ergometers in conjunction with a virtual reality interface. The purpose of this study is to examine participant perspectives regarding the virtual interface and exercise device combination with regard to usability, comfort, safety, rating of perceived exertion, and enjoyment.
Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and Placement (VR4VR) is a project that incorporates Virtual Reality into job training to increase job opportunities for people who have physical or mental disabilities. The investigators are using Virtual Reality and robotics for job evaluation, training and placement of people with disabilities. The investigators' goal is to assess and train people in a safe, adaptable, and fun virtual environment similar to a video game. This is an interventional study with three target populations: autism spectrum disorder, traumatic brain injury, and severe mobility and manipulation impairments. The prototype system allows for a wide range of environments with the vocational evaluator easily controlling the virtual experience, while the job seekers interact realistically.
The goal of this clinical trial is to test the effects of MitoQ supplementation in older adults and frail older adults with physical dysfunction and/or cognitive dysfunction. The main question\[s\] it aims to answer are: * To compare vascular function, oxidative stress levels, and physical and cognitive function among older adults and frail older adults with physical and cognitive dysfunction * To determine whether MitoQ supplementation has the potential to improve vascular function in central and cerebral vessels * To determine whether MitoQ supplementation can enhance physical and cognitive capabilities.
The overall objective of the proposed randomized controlled (RCT) is to determine the feasibility and efficacy of a 16-week theory-based, remotely-delivered, combined exercise (aerobic and resistance) training intervention for improving cognitive and physical function in older adults (50+ years) with multiple sclerosis (MS) who have mild-to-moderate cognitive and walking impairment. Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant's home/community and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. It is hypothesized that the home-based exercise intervention will yield beneficial effects on cognition, mobility, physical activity, and vascular function compared with an active control condition (flexibility and stretching intervention), and these improvements will be sustained during a 16-week follow-up period.
The BEET PAD Trial is a multi-centered double-blind randomized clinical trial designed to determine whether beetroot juice, compared to placebo, improves six-minute walk distance at four month follow-up in people with lower extremity peripheral artery disease (PAD). Investigators hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. The primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. The primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, investigators will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling) and gastrocnemius muscle health. The trial will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion. The trial will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively.
In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a multidimensional visual impairment simulation. The platform is utilized: i) to provide a safe, controllable, and repeatable set of environments for development and preliminary testing of electronic travel aids (ETAs) in a variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii) to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility (O\&M) instructors, with a controlled, tunable training platform for skill/capacity building, assessment, and refinement of O\&M techniques, as well as visually impaired trainees with a safe and immersive environment to improve their O\&M skills and learn novel techniques. Two sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform with respect to these two objectives.
The purpose of this research study is to evaluate the usefulness of a wearable robotic exoskeleton device (Ekso-GT), to improve learning and memory, and gait therapy in persons with walking disability due to Multiple Sclerosis. The study will evaluate the mobility, learning and memory, and walking abilities of individuals with multiple sclerosis who went through the traditional as compared to others who used the robotic exoskeleton as part of their therapy.
Neck pain, neck muscle weakness, and limited neck range of motion have been shown in individuals with sinus headaches. Individuals in this previous study self-diagnosed their sinus headaches. It is unknown whether or not individuals who have been diagnosed with sinus headaches according to diagnostic criteria also present with musculoskeletal impairments. The purpose of this study is to determine if musculoskeletal neck impairments are present in individuals diagnosed with headaches attributed to rhinosinusitis compared to people without headaches. Upper cervical range of motion can be measured using different tests. The side bend rotation test has been suggested as potentially more useful than the flexion rotation test in individuals with hyper-laxity, however, has not been examined in a symptomatic population. A secondary purpose is to compare the side bend rotation test to the cervical flexion rotation test in people with varying degrees of joint laxity.
This is a single-site non-randomized open label pilot study. The investigators will use accelerometer-based instrumented gait analysis and computerized cognitive testing to study the interaction of motor and cognitive dysfunction in Parkinson disease dementia (PDD), and the effect of rivastigmine on motor and cognitive performance. All study participants will be tested for motor and cognitive performance at baseline (arm 1). A subgroup of study participants will then be treated with rivastigmine for 12 weeks (arm 2), and the effect of this treatment on gait measures and cognitive measures will be analyzed at the follow-up visit 12 weeks after the baseline visit. Specifically, we will determine which components of motor and cognitive impairment are associated with each other, and which components of the two domains respond to rivastigmine-mediated stimulation of cholinergic neurotransmission.
The National Eye Institute estimated about 3 million people over age 40 in the US had low vision in 2010 and projects an increase to nearly 5 million in 2030 and 9 million in 2050. Current assistive technologies are a patchwork of mostly low-technology aids with limited capabilities that are often difficult to use, and are not widely adopted. This shortfall in capabilities of assistive technology often stems from lack of a user-centered design approach and is a critical barrier to improve the everyday activities of life (EDAL) and the quality of life (QOL) for individuals with low vision. An intuitive head mounted display (HMD) system on enhancing orientation and mobility (O\&M) and crosswalk navigation, could improve independence, potentially decrease falls, and improve EDAL and QOL. The central hypothesis is that an electronic navigation system incorporating computer vision will enhance O\&M for individuals with low vision. The goal is to develop and validate a smartHMD by incorporating advanced computer vision algorithms and flexible user interfaces that can be precisely tailored to an individual's O\&M need. This project will address the specific question of mobility while the subject crosses a street at a signaled crosswalk. This is a dangerous and difficult task for visually impaired patients and a significant barrier to independent mobility.
Loss of mobility and cognitive ability are serious conditions that threaten the independence of older adults. The objective of this study is to initiate a line of research to develop a novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of frontal/executive circuits.