23 Clinical Trials for Various Conditions
This is a proposal to develop a Balanced Reach Training Protocol (BRTP) to evaluate and train dynamic standing balance. The BRTP is based upon the Balanced Reach Test (BRT) that the investigators previously developed and validated. In the BRT subjects stand and point to a target disk moving unpredictably across a large projection screen in front of them without stepping. Body movements undertaken to track the disk are integral to many daily activities and represent an important class of "expected" balance disturbances that can precipitate falls. The BRTP employs engineering and psychophysical methods, and exploits advances in real time computing in a novel and innovative way to more effectively evaluate and train balance function. The BRTP presents a challenging reaching/tracking task that subjects perform at their limit of balance. The BRTP is an objective, quantitative test that can evaluate balance function without floor or ceiling effects, and train balance across the spectrum of aging, disease, and injury.
Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.
Postural instability is a common symptom of vestibular dysfunction that impacts a person's day-to-day activities. Vestibular rehabilitation is effective in decreasing dizziness, visual symptoms and improving postural control through several mechanisms including sensory reweighting. As part of the sensory reweighting mechanisms, vestibular activation training with headshake activities influence vestibular reflexes. However, combining challenging vestibular and postural tasks to facilitate more effective rehabilitation outcomes is under-utilized. The novel concurrent headshake and weight shift training (Concurrent HS-WST) is purported to train the vestibular system to directly impact the postural control system simultaneously and engage sensory reweighting to improve balance. Young healthy participants will perform the training by donning a virtual reality headset with an overhead harness on and a spotter present to prevent any falls. The investigators propose that this training strategy would show improved outcomes over traditional training methods by improving vestibular-ocular reflex (VOR) gains, eye movement variability, sensory reweighting and promoting postural balance. The findings of this study may guide clinicians to develop rehabilitation methods for vestibular postural control in neurological populations with vestibular and/or sensorimotor control impairment.
This study investigates the use of wearable devices and a sleep diary for tracking sleep and its impact on cognition and balance in older adults over six weeks. It will include routine mobility, balance assessment, and cognitive evaluations, focusing on analyzing the relationships between sleep, mobility, balance, and cognition.
Accidental falls in older adults are highly prevalent and a major source of morbidity. Over 30% of people aged 65 or older fall each year with about half of these cases being recurrent. Falls may result in head trauma, bone fractures, and even death and are leading cause of both nonfatal and fatal injuries in older adults. The Nintendo Wii Fit is a suite of exercise and fitness video games using a balance board periphery developed for the Wii console. The purpose of this study is to determine the feasibility and validity of the Nintendo Wii Fit, in detecting balance problems in older community dwelling adults.20 ambulatory older adults will be recruited to participate in this study.Subject will be asked to complete 1 study visit. In this visit information will be gathered about the subjects overall health including fall assessments. Qualified subjects will be randomized into two study groups where one group will begin the study with Wii Fit testing followed by NeuroCom EquiTest evaluation and the other group in reversed order.
The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain injury) system is a novel portable, open access platform that enables immediate and rapid assessment of multimodal neurologic function. This study seeks to evaluate the iDETECT function testing battery with currently used balance and inner ear assessment methods during initial concussion clinic referral. Two groups of participants will be enrolled; a concussion related dizziness cohort and control subjects. The investigators will enroll the concussion cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent dizziness and imbalance symptoms following possible concussion. Healthy control participants will be recruited from the local community. iDETECT's ability to identify post concussion balance/vestibular disturbances will be compared to an expert concussion assessment. Both cohorts will participate in the iDETECT assessment and the clinical assessment.
The primary purpose of this study is to test different methods of measuring energy balance, including food intake and energy expenditure. Another primary purpose of this study is to see if energy expenditure predicts weight and change after a weight loss diet. A secondary aim will be to test the reliability and validity of the Actical accelerometer, SenseWear Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated energy expenditure or posture allocation from the 3 devices is associated with weight change during and following a low calorie diet (LCD).
The goal of this study is to assess the individualized use of technology to assess motor function and balance for ambulatory children participating in an intensive therapy episode of care and determine the effectiveness of the program. Children 7-17 years old who can walk and are completing an intensive therapy episode of care will be recruited to participate in this study. Demographic, health history, and PT,OT,ST medical records will be collected. Based on the participant's functional goals, motor function and balance tests will be selected including common balance tests (standing with eyes open, standing with eyes closed), walking, walking and turning, standing up and sitting down from a bench, reaction time, and step down. Participants will be tested before, immediately after, 6 weeks after, and 12 weeks after the episode of care.
This study is a randomized controlled trial designed to compare the effects of 4 weeks of chiropractic care to a waitlist control group on measures of strength, balance, and endurance in military personnel experiencing non-surgical low back pain.
This project will determine the feasibility and efficacy of remote assessment and treatment of balance disorders in people with Parkinson's disease.
This study will evaluate the effectiveness of FSST 2.0 (family supportive supervisor training plus support for use of family and sick leaves) using a randomized control trial design. We expect the intervention will increase supervisors' family supportive and leave supportive behaviors, which in turn will increase employees' leave use and decrease employees' work-family conflict, emotional exhaustion, depressive symptoms, and turnover intentions. This study will enroll a minimum 200 groups of managers and their employees. Managers in the intervention condition will complete pre- and 2 post-intervention Workplace Assessments, 2 online training modules, 1 webinar where managers can review intervention content and ask questions and share reactions on the materials. Managers in the control group and employees in both groups will complete pre- and 2 post-intervention Workplace Assessments. The post-intervention Workplace Assessment will be completed 3 and 6 months after the intervention. The total duration of the study is 9 months as the wait list control group will be offered the intervention and 2nd follow up survey after the 6-month trial.
Falls are by far the leading cause of accidental injury and death in older adults. The Veteran population is more severely affected by falls since it is significantly older than the overall population (45% over 65 years of age vs. 13%); and Veterans would benefit substantially more from an accurate diagnosis and treatment of fall propensity. Despite its importance, much is still unknown about the manner in which balance control is compromised by age and disease. Therapeutic interventions for people who are at risk of falling have proven to be of limited utility. Engineering methods are well suited to study and evaluate balance; but have to date been applied to overly simplified scenarios that lack the complexity to probe the musculoskeletal and neurophysiological bases for balance and falls. The long term objective of this research, which began with a VA Rehabilitation Research \& Development (RR\&D) Career Development Award (CDA-2), is to develop improved directives and protocols for the diagnosis and treatment of balance-related posture and movement coordination problems. This proposal significantly advances engineering methods to address existing gaps in the diagnosis and treatment of balance impairments through the development of a Balanced Assessment and Training Protocol (BATP). The BATP continuously challenges subjects to perform reaching tasks at the limits of their balance for an extended period of time, and increases these limits as subjects demonstrate improved performance. The goal of this tool is to quantitatively assess and improve at-risk individuals' ability to maintain balance when disturbed by volitional movements of the body and its parts-an important class of balance disturbances integral to many activities of daily living that can precipitate falls. The BATP focuses on performance at and just beyond the limits of balance, unlike most such tests and training protocols that do not challenge subjects in this way. The BATP's most immediate and salient metric is the limiting boundary of standing reach; and we hypothesize that expanding this boundary, as the BATP is designed to do, will improve balance and make individuals more resistant to falls (in the context of expected balance disturbances). Confirmation of this hypothesis could provide a new perspective on existing training protocols' modest success rates, and direction for the design of new protocols with the potential to significantly improve these rates. \[Though the BATP is a training platform, we also believe that the performance metrics and analytical results produced by it can form the basis for new diagnostic measures that more reliably and precisely quantify and explain balance performance problems; and track changes in them over time.\] Such diagnostic and treatment protocols would be particularly beneficial to the VA Health Care System, as it would lead to improvements in: patient throughput, quality of care, and treatment costs. Though this proposal targets the aging Veteran population, the BATP is a general tool that can aid in the diagnosis and treatment of balance disorders arising from conditions other than aging. These include obesity, diabetes (which often leads to lower extremity muscle degeneration and peripheral neuropathy), sarcopenia, vestibular disorders, and neurological disorders such as stroke. Veterans whose balance has been compromised by Traumatic Brain Injury (TBI) (whether combat-related or not) may also benefit from the BATP.
The overall objective is to evaluate objective dual-task turning measures for use as rehabilitative outcomes and as tools for return-to-duty assessments in individuals with mild traumatic brain injury (mTBI).This project consists of three goals examining the I) Diagnostic Accuracy, II) Predictive Capacity, and III) Responsiveness to Intervention of dual task turning measures in individuals with mTBI. The investigators hypothesize that objective measures of dual-task turning will have high diagnostic accuracy, predictive capacity, and responsiveness to intervention in people with mTBI.
This is a pilot study to establish an arterial venous methodology to measure the activity of the TCA cycle or flux directly in tissues of human beings. It will also perform correlative studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and exosomes derived from the arterial venous supply of tissues with correlation to the TCA cycle activity.
Our central hypothesis is that chronic balance deficits after mild traumatic brain injury (mTBI) result from impairments in central sensorimotor integration (CSMI) that may be helped by rehabilitation. There are two objectives of this proposal; the first objective is to characterize balance deficits in people with mTBI. The second objective is to use a novel auditory bio-feedback (ABF) device to improve measures central sensorimotor integration and balance control.
The purpose of this research study is to investigate how useful three balance tests are in predicting fall risk in the individual with traumatic brain injury (TBI). These tests are the Functional Gait Assessment (FGA), the Berg Balance Scale (BBS), and the mini-Balance Evaluation Systems Test (mini-BESTest).
Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.
The goal of this study is to evaluate children and adolescents with idiopathic scoliosis who are undergoing spinal fusion using motion analysis, balance, and outcome questionnaires. Little research has been done to evaluate how different fusion levels impact walking patterns, range of motion, posture and balance following spine instrumentation in children with idiopathic scoliosis. Debate still continues whether posterior spinal instrumentation with the last instrumented vertebra at or above Lumbar 3 (L3) will provide sufficient spine correction, greater motion, and better posture and balance when compared to a child with instrumentation at Lumbar 4 (L4). Furthermore, how does the spine fusion endpoint (last instrumented vertebra) impact quality of life, participation, and impairment in children and adolescents with idiopathic scoliosis and how do they compare to healthy age-matched peers. The goal of this study is to compare these two end points using gait analysis, postural stability, and outcome tools with the hopes of providing better clinical care to children with idiopathic scoliosis.
The purpose of this pilot study is to characterize changes in postural orientation and equilibrium in early diagnosed ALS patient. The investigators plan to cross validate the use of a standardized test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in early diagnosed ALS patients.
Researchers at the University of North Carolina at Greensboro conduct a single-arm intervention trial to investigate the efficacy of a music-based group exercise program for community-dwelling older adults. Up to forty participants will be recruited to participate in a music-based light-to-moderate intensity group exercise program for 20 weeks (30 - 40 min/day, up to 6 days/week), which is designed for older adults with or without functional limitations to exercise with chairs for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace. During the exercise sessions, participants will be trained to move in time with music playlists in synchronous tempos. Primary outcomes are cognitive performance, mobility, and health-related quality of life measured before and after the intervention. Secondary outcomes are adherence to the exercise program as a potential mediator of the treatment.
The purpose of this study is to assess the effects of visual and auditory distractions on SCAT5 scores. The study is designed to identify the effects of about 80 participants completing the SCAT5 in college-aged athletes. All participants will perform the same tasks in two settings (distracted and non-distracted). The central hypothesis is that there will be a significant association between distractions and a lower score on the SCAT5. The cognitive screening, neurological screen, and mBESS should showcase a decrease scores during the distracted environment.
This study aims to explore possible solutions needed for valid and reliable multidimensional objective assessment tools to use in screening performers for concussions, as well as, for use postinjury assessment and management of the mild traumatic brain injury, regardless of time since injury occurrence. These mobile tools would also enable clinicians to test the effectiveness of the interventions used post-concussion, prior to fully releasing the performer back into full performance/active status.
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.