20 Clinical Trials for Various Conditions
The purpose of this study is to determine if varenicline is effective in improving gait and balance impairment in patients with Parkinson disease.
Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.
ZeroG is an FDA-listed robotic body weight support system (BWSS). Mounted on an overhead track, patients are fitted in a harness system tethered to said track, and are able to practice gait and balance activities without the risk of falling. This compensates for ineffective postural control permitting intensive therapy sessions earlier in recovery. The purpose of this study is to determine if inducing effective and safe balance perturbations during standing and walking in the BWSS more effectively improve postural control than the BWSS without perturbations. The target population are those patients in the post-acute phase of stroke admitted for inpatient rehabilitation of balance impairments. Site investigators and/or research staff will obtain names of potential subjects from internal reporting identifying inpatients who may qualify for the study based on the inclusion criteria. Trained site investigators will meet with potential subjects to explain the study, complete a screening interview for exclusion and inclusion criteria, answer any questions, obtain informed consent and HIPAA authorization, and schedule the study therapy sessions involving the protocol. Based on the randomization scheme provided by the lead site, consented subjects will be randomized to either the BWSS with perturbations (BWSS-P) or standard BWSS control without perturbations. Subjects will perform 2 to 6 sessions in their designated intervention using a structured protocol for each session. To compare differences between treatment groups, outcome measures will be collected at baseline before any BWSS sessions are performed and within 48 hours after completing the final treatment session.
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.
Alzheimer's Dementia (AD) contributes to poor balance, impaired gait and functional status, thereby, increasing the risk of falls. AD is an independent risk factor for hip fractures. Those with balance problems and gait impairments are at higher risk for long term placement and death related to falls. Exercise interventions improve gait and balance in the elderly. In participants with existing AD, physical activity has shown to prevent further cognitive decline and improve quality of life and prevent falls. However, it is difficult to engage patients with AD in long term exercise programs. The expense of physical therapy limits its easy accessibility. Use of everyday technology might bridge this gap by providing high level of engagement via the use of multimedia while providing a cost-effective alternative. Wii Fit is one such multimedia platform. Wii fit is a Nintendo gaming console used for aerobics, strength training and balance activities. This device includes a balance board that senses weight and shifts in movement and balance. Virtual trainers talk the user through the activity while tracking the user's progress. The investigators propose an 8-week prospective randomized study with the treatment group receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a walking exercise program in a community dwelling setting. Subjects in each arm will participate for 30 minutes daily five days a week.
To study the effect of chiropractic care and a specific exercise program on balance in older adults.
This clinical trial studies how well Diode laser fiber type Selective Stimulator (DLss) works in predicting pain development in patients with ovarian cancer who are receiving chemotherapy. Stimulating of the pain nerve fibers in the skin with laser light stimulation may help to predict whether a patient will develop painful peripheral neuropathy, correlate with the severity of neuropathy during and after chemotherapy treatment, and may help to explain the mechanisms of chemotherapy-induced neuropathic pain (CIPN).
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.
Problems with walking and balance are common in older adults with mild cognitive impairment. Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/mixed reality (MR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training in older adults with mild cognitive impairment. The study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR/MR training (CM), and 3) standard of care (CTRL) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CM.
Background Balance impairment is a key factor contributing to falls in older adults. Conceptually, clinicians may be able to prescribe targeted exercises if specific impairments can be identified. Objective Our objective was to use a model of balance subsystems to identify balance impairments and demonstrate the effectiveness of targeted (matched) exercises to improve balance and reduce fall risk in community-dwelling older adults. The investigators used the Balance Evaluation System Test (BESTest) as the model because it categorizes balance into 6 subsystems. Design Randomized, partially blinded, pretest-post-test clinical trial consisting of 2 Phases: 1. A comparison between impairment-matched exercises and a control, and 2. A comparison between impairment-matched and mismatched exercises. Setting Senior independent living community. Participants Adult volunteers (n = 40; aged 74-94) recruited as sample of convenience who met the criteria. Participants (n = 20) identified with impairment in the biomechanical (BC) constraints subsystem and participants (n = 20) with impairment in anticipatory postural adjustment (APA) subsystem were enrolled and randomized into 2 subgroups (matched and control/delayed mismatched; n = 10 each subgroup). Intervention Phase 1: Participants in the matched subgroup received a 6-week exercise program matched to their impaired subsystem while the mismatched subgroup served as control. Phase 2: Following the delay, participants in the mismatched group received a 6-week exercise program mismatched to their impairment. Measurements Primary outcome variables were scores on the targeted subsystem (BC, APA), BESTest total, Berg Balance Scale, and fear of falling measure. Quality of life was a secondary outcome. Outcome data were collected by the tester blind to pretest scores and group allocation. Results The matched exercise subgroups demonstrated both statistical and clinical improvement in all outcome variables compared to the control; and showed greater improvement in balance impairments compared to the mismatched subgroup, but not in fall risk reduction. Limitations The therapist who administered the pretest knew the subgroup assignment and implemented the exercises. Conclusions Results provide preliminary evidence that using a balance assessment model to identify impairments in the BC and APA subsystems and prescribing targeted exercises reduces these balance impairments for older adults and may warrant future studies.
The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment. The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only.
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with chronic severe stroke-related walking impairment. The two approaches involve either forward or backwards treadmill training. This study will look at changes in walking performance and balance, before and after training. This study may lead to more efficient methods for improving walking performance and balance after stroke.
The composite effect of reduced balance, cognition, gait abnormalities/gait disturbances, and physical activity in older adults with mild cognitive impairments (MCI) leads to fear of falling and reduced participation in daily activities, which results in reduced cardiovascular fitness and deconditioning. Although many conventional balance and strength training programs have been implemented for older adults with MCI; these adults do not receive adequate practice dosage to make significant improvements, most likely due to lack of adherence to therapy and/or inadequate incorporation of all domains of the ICF model (body functions and structures, activities and participation) and lack of targeting cognitive-motor interference (deterioration of motor and/or cognitive function when both tasks are performed together). The use of alternative therapies such as dance and virtual reality (VR) has been found to be relatively enjoyable for older adults due to increased motivation, which led to the added improvement of physical and cognitive functioning. The overall aims of this pilot is to test the feasibility of VR-based dance therapy paradigm for older adults with MCI as well as its effect on enhancing balance, gait, and cognition, and physical fitness. Investigators also hope that the net effect of improvement in these domains of health outcomes will result in pre and post reduction of fall risk and improved quality of life of older adults with MCI. The study investigates the effectiveness of a VR (Kinect)-based dance therapy in older adults with MCI by demonstrating its feasibility and compliance rate and also determine the efficacy of the VR-based dance therapy in improving health outcomes such as motor and cognitive functions, thereby reducing cognitive-motor interference. The study will also aim to determine the effectiveness of the VR-based dance paradigm in improving cardiovascular fitness and physical activity (PA) in older adults with MCI
Older adults often display gait instability, impaired balance control and cognitive decline that lead to falls and fall risks. Approximately 60% of the elderly people with cognitive deficits experience a detrimental fall each year. Such motor and cognitive impairments further decreases physical activity levels in this population leading to restricted community integration, social behavior, depression and long-term disability. With the help of computer technology, studies have employed virtual-reality based interventions to address the above-mentioned concerns including sensori-motor, balance control and cognitive impairments. Previous studies have demonstrated promising results on improving the behavioral outcomes, and have identified such interventions have the potential to improve the underlying neurophysiological outcomes as well. While VR based training studies have demonstrated remarkable improvement in the balance control and gait parameters, physical activity levels and fall risk reduction, the gains on cognitive function is less pronounced. There is little evidence that VR-based training can explicitly address the higher executive cognitive domains associated with balance control and falls. Further, the effect of VR-based training on balance control and cognitive function is unknown among the older adults with mild cognitive impairment. Therefore, to address the cognitive domains explicitly, the current study aims to test the applicability of Wii-Fit Nintendo along with an additional cognitive load delivered via VR-based cognitive-motor training paradigm (VR-CogMoBal) in older adults with mild cognitive impairment. Lastly, the study also aims to identify the effect of such training on the underlying behavioral and neural outcomes. The behavioral outcomes will be assessed via performance on dual-tasking and clinical measures in the laboratory. The underlying neural outcomes will be assessed via fMRI outcomes. In order to determine the generalizing training effect at community level, a pilot sub-study to determine the physical activity levels post 4 weeks of training will also be conducted.
Falls are a significant issue for older adults with vision impairment. Medical conditions such as glaucoma and age-related macular degeneration that result in vision impairment negatively impact balance. Falling is 1.7 times more likely among older adults with vision impairment. In 2010 there were 9,146,026 older adults treated in emergency rooms for unintentional falls and injuries from falls are expected to cost the nation an estimated $54.9 billion dollars by 2020. Falls can lead to death, depression, and loss of independence. However, impaired balance is a modifiable risk factor for falls. A practical yet innovative falls prevention program has been developed that is designed to enhance balance and proprioception among older adults. This program, UExCEL (UNE-Exercise and Conditioning for Easier Living) Balancing Act, consists of simple exercises that can be done at home (15 minutes duration-3 times a week) during normal daily activities, requires only one brief training session, and no equipment. This study aims to establish an evidence base documenting the positive impact of Balancing Act exercises on balance and falls prevention for older adults with vision impairment. A randomized controlled trial of older adults with vision impairment (best corrected vision of 20/70 or worse) will be conducted over a 6-month period (control group n = 35 and Balancing Act intervention group n = 35) to determine the impact of Balancing Act on falls, fear of falling, pain, and activity levels. Factors that can be expected to affect its adoption and sustained use such as cost in the community and social support networks in the home will also be investigated. It is hypothesized that the Balancing Act intervention will decrease the number of falls experienced by older adults who have vision impairment by improving their gait and balance, reducing their fear of falling, increasing their physical activity, and reducing their pain. The specific aims of the research are to: 1) Evaluate the impact of Balancing Act on standing balance control and proprioception for older adults who have vision impairment, using the Tinetti Gait \& Balance Test, a validated tool for evaluating gait and balance and predicting fall risk; 2) Evaluate the impact of Balancing Act for older adults with vision impairment on falls, fear of falling, physical activity, and pain; and 3) Improve adherence to the Balancing Act exercise program by facilitating social networks. Data will be analyzed through: 1) a descriptive assessment of the baseline demographic characteristics of sample members, covariates, and outcome variables, as well as 2) a repeated measures design examining the impact of the intervention on study participants.
Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely prevent, or reverse neuropathy associated with IGR and this represents a considerable challenge in rehabilitation. There is a particularly strong incentive to prevent IGT and related complications from advancing to DM2. IGR is a growing problem among all older adults and its strong association with many functional limitations, particularly mobility limitations, is not always recognized, even though diabetes-related disability occurs in up to 2/3 of older adults with diabetes and is associated with dependency, poor quality of life, and increased acute and long-term care utilization. Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data shows that over 90% of subjects with IGT have an abnormal score on questionnaires about autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet that are colder than the rest of the body, decreased sweating in the feet or increased sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation, or leaking of urine. In addition, patients with IGR have impaired balance control. These factors can increase the risk of falls in affected subjects. A non-randomized and non-controlled study showed that a diet and exercise intervention in patients with diabetes led to an overall improvement in autonomic function. Furthermore, it was shown that standing balance can be improved with a balance intervention program. However, there are no published studies that assess the effect of an intense physical activity intervention on autonomic function in IGR related neuropathy. This study will test an aerobic exercise and balance intervention in participants with IGR. The investigators will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when compared to patients who receive standard care. Improving balance control and autonomic function can decrease the risk of falls and have a significant effect on the health of participants. The research is also significant because it will test subjects either before they become diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the autonomic neuropathy or balance impairment. Furthermore, the study is designed to test whether improvement in autonomic function and balance is associated with improvement in clinical outcomes, quality of life, and the metabolic state of participants. Thus, the proposed interventions are likely to have a real life impact on participants and their health.
The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD. The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from treatment initiation in patients with moderately advanced PD, whose gait impairment is an important source of disability despite optimized antiparkinsonian treatment.
This study will try to identify the genetic causes of hereditary hearing loss or balance disorders. People with a hearing or balance disorder that affects more than one family member may be eligible for this study. They and their immediate family members may undergo some or all of the following procedures: * Medical and family history, including questions about hearing, balance and other ear-related issues, and review of medical records. * Routine physical examination. * Blood draw or buccal swab (brushing inside the cheek to collect cells) - Tissue is collected for DNA analysis to look for changes in genes that may be related to hearing loss. * Hearing tests - The subject listens for tones emitted through a small earphone. * Balance tests to see if balance functions of the inner ear are associated with the hearing loss In one test the subject wears goggles and watches moving lights while cold or warm air is blown into the ears. A second test involves sitting in a spinning chair in a quiet, dark room. * Photograph - A photograph may be taken as a record of eye shape and color, distance between the eyes, and hair color. * Computed tomography (CT) and magnetic resonance imaging (MRI) scans - These tests show the structure of the inner ear. For CT, the subject lies still for a short time while X-ray images are obtained. For MRI, the patient lies on a stretcher that is moved into a cylindrical machine with a strong magnetic field. The magnetic field and radio waves produce images of the inner ear. The radio waves cause loud thumping noises that can be muffled by the use of earplugs.
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.
Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military populations and can be debilitating if symptoms do not resolve after injury. Balance problems are one of the most common complaints after sustaining a mTBI and often prevent individuals from returning to their previous quality of life. However, the investigators currently lack clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if early physical therapy is beneficial. The investigators believe that the underlying problem of imbalance results from damage to parts of the brain responsible for interpreting sensory information for balance control. The investigators hypothesize that retraining the brain early, as opposed to months after injury, to correctly interpret sensory information will improve recovery. The investigators also believe this retraining is limited when rehabilitation exercises are performed incorrectly, and that performance feedback from wearable sensors, can improve balance rehabilitation. There are three objectives of this study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to determine if home monitoring of balance exercises using wearable sensors improves outcomes; and 3) to develop a novel feedback system using wearable sensors to provide the physical therapist information, in real-time during training, about quality of head and trunk movements during prescribed exercises. The findings from this research could be very readily adopted into military protocols for post-mTBI care and have the potential to produce better balance rehabilitation and quality of life for mTBI patients and their families.