41 Clinical Trials for Various Conditions
Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaningful that there is greater decline in performance of at least one task when comparing single and dual-tasking. Difficulty dual-tasking may actually predict falls in community-dwelling older adults. Dual-task training has been shown to improve cognitive outcomes (attention, memory), motor outcomes (balance, gait), and dual-task performance in older adults; however, most dual-task training involves simulated tasks that do not reflect functional dual tasks in the real world. Greater dual-task improvements could be seen when training functionally specific tasks. One way to increase task specificity is to offer real-life, contextually-relevant, dual-task training embedded in instrumental activities of daily living (IADLs). Limited evidence exists for dual-task training interventions for older adults with T2DM; however there is early evidence of improvements in cognitive and motor effects with simulated dual-task training, which could translate to improved dual-task performance, reduced impact on everyday life, and reduced fall risk. Therefore, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a real-life dual-task training program for older adults at risk to fall.
The goal of this project is to evaluate the safety and preliminary effectiveness of utilizing a digital therapeutic, Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD with a previously implanted deep brain stimulator (DBS).
The investigators previously developed a virtual 14-day dual-task walking exercise program and tested its feasibility with individuals with mild traumatic brain injury (mTBI) history. The investigators will test the feasibility and efficacy of a mobile app-version (Uplode) of the same 14-day exercise program (Brain \& Walk Exercise Every Day \[BraW-Day\]), on cognition, sensorimotor, and other functions in a group of voluntary young adults with an mTBI between last three months to two years, including student athletes, Veterans, and ethnic minorities.
To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.
The investigators have designed a brain stimulation study to understand its effect on an individual's standing, walking, and thinking abilities in older adults with and without mild cognitive impairments (MCI). The transcranial alternating current stimulation (tACS) technology has been safely and effectively used in hundreds of individuals. The purpose of this study is to test whether a single session of tACS as compared to sham intervention, improves standing, walking, and thinking in older adults with and without mild cognitive impairments (MCI). Approximately 60 people will take part in this study.
The specific aims of the research study are: 1. Compare single-task gait parameters between individuals with hearing loss (HL) and age and education matched controls with normal hearing \[normal vs moderate-profound hearing loss (N=23 for each group)\]. For that we will compare the primary outcome measure, gait speed, between the groups while participants are walking at a comfortable speed for 1 minute. 2. Compare cognitive function between individuals with HL and age and education matched controls. For that we will compare the Neurocognitive Index, derived from a cognitive assessment between groups. 3. Compare the effect of a cognitive task while walking on gait parameters between people with HL and age education matched controls with normal hearing. For that we will compare the primary outcome measure, gait speed, between groups while participants are walking at a comfortable speed and counting backwards \[serial subtraction of 3\] for 1 minute. 4. Explore whether cognitive performance (i.e., the Neurocognitive Index) is correlated with Dual task cost (DTC), a deterioration of gait speed while walking and performing concurrent cognitive task \[serial subtraction of 3\]. The formula to calculate this is the following: DTC = 100 X \[(DT - single task)/ single task\].
This study seeks to understand what factors influence the capacity to perform simultaneous motor and cognitive tasks in older adults to improve movement throughout their community with the least risk of injury. To function in the real world, one needs to "walk and talk", or to move about the community while attending to their environment. Navigating a busy environment becomes increasingly difficult due to the multitude of constraints placed on the organism by both the brain and the body that are associated with aging. Resulting lack of movement causes a downward spiral; further decreasing function and increasing risk of co-morbidities. This will impose an enormous cost on our healthcare system as the elderly population continues to grow in the United States. The investigators aim to investigate both cognitive and movement changes during aging to prevent declines in functional mobility. The investigators will do this through eight weeks training of simultaneous cognitive and motor tasks (cognitive-motor training).
Veterans with dysvascular lower limb amputation (LLA) have a high fall risk, which persists despite completion of conventional rehabilitation. The presence of fall risk could be a primary reason for the high disability and low quality of life outcomes in this Veteran population. A potential novel intervention for this population is to train performance of tasks that require both physical and cognitive attention (i.e., dual-tasking). Therefore, the purpose of this study is to explore relationships between dual-task performance and self-reported falls for Veterans with dysvascular LLA. Further, dual-tasking occurs during everyday life and this project will examine the association between dual-task performance and participation in activities of daily living (basic and instrumental). The results will form the foundation for development and future study of a novel dual-task training program for Veterans with dysvascular LLA.
This project is focused on conducting a home-based, thinking while moving exercise intervention for adults 65 years or older, who have mild cognitive impairment, that will integrate several effective training modalities including non-contact cardio-kickboxing, stepping exercise, balance/functional training, and muscle strengthening. Cognitive function, physical function, and dual-task abilities will be assessed over the 12-week intervention and comparisons will be made between participants in the exercise intervention and control participants receiving no intervention.
Studies have determined that compared to cognitively intact older adults (CIOA), older adults with mild cognitive impairment (OAwMCI) exhibit more pronounced balance and gait impairments which lead to an increased risk of falls and mobility decline. Such impairments are evident during dual-tasking (i.e., simultaneous performance of cognitive and motor task) and OAwMCI have demonstrated an increased cognitive-motor interference (deteriorated performance of either or both cognitive/motor task). Furthermore, our preliminary laboratory findings indicate that compared to CIOA, OAwMCI in response to large-magnitude treadmill perturbations exhibits poor reactive responses (first line of defense against balance loss) and are unable to modulate their responses as the magnitude of perturbation increases. Despite that conventional exercise methods offer beneficial effects; they comprise of self-initiated task-specific exercises and may not focus on training reactive responses. Additionally, due to the presence of subtle balance and gait deficits, clinical measures used may not be sensitive enough to determine the risk of fall post-training. Furthermore, these training methods incorporate multiple sessions due to which adherence to exercise training is difficult with only a fraction of the older adults benefiting from it. Therefore, it is essential to incorporate a task-specific strategy that promotes factors associated with falling like balance control, muscular responses, coordination of limbs, and cognition through which OAwMCI may acquire maximum benefits to prevent a balance loss. One feasible method, which harnesses technology that can be used to deliver balance disturbances either while standing or walking in a consistent and controlled manner, is via a custom-based motorized treadmill. The scientific rigor from preliminary studies has reported a successful reduction of falls through a single session exposing CIOA to multiple treadmill-induced perturbations during gait and has shown significant improvement in reactive responses. For that reason, this stage 1 pilot study will examine the feasibility, applicability, and tolerability of a combined cognitive, and perturbation training on biomechanical determinants associated with falls and promote physical activity: kinematic variables, muscular responses, and cognitive function.
Activities of daily living (ADL) frequently involve the simultaneous performance of two or more tasks, such as crossing the street while holding a conversation, commonly referred to as dual tasking. The simultaneous performance of a motor and a cognitive task increases postural instability, gait dysfunction, and may increase fall rates in Parkinson's disease (PD). The goal of this project is to evaluate the effectiveness of utilizing a digital therapeutic, Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD. A randomized controlled trial will be conducted at the Main Campus of the Cleveland Clinic (Cleveland, OH). A total of 50 individuals with Parkinson's disease will be randomized into 1) a traditional multi-modal training group, or 2) multi-modal training administered via an augmented reality headset. Multi-modal therapy is where the participant practices performing two things at once (i.e. marching while answering math questions). Augmented reality is a type of head-worn technology that allows the individual to see the real world and places holograms in the space. Both groups will exercise 2x/week for a total of 8 weeks. Assessments involving walking, balancing, and turning will be completed to assess the efficacy of the treatment.
The objective of this study is to determine the acute effects of single sessions of optimized tDCS, conventional tDCS, and sham stimulation on dual task standing and walking in older adults who are free of overt disease yet who present with poor baseline dual task performance.
Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and severe dementia associated with Alzheimer's disease (AD). In the United States about 20% of older adults have MCI. Loss of cognitive function in aging can have far-reaching and devastating impacts on functional status, independence, and quality of life. Unfortunately, the therapeutic options to slow progression of cognitive decline in aging are limited. Dual-task training; that which involves simultaneous cognitive and motor challenges, is a high-impact potential therapy to slow progressive loss of both motor and cognitive function in aging. The purpose of this trial is to examine the feasibility and therapeutic impact of a novel dual-task physical activity intervention on executive and motor functions among adults, 65 years or older, who have MCI. the investigative team anticipates that findings from this trial will inform development of larger community-based studies focused on improving function and ability to maintain independence in older age.
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.
People with Parkinson disease commonly experience difficulty driving, which requires the arms and legs to do different tasks simultaneously. Driving difficulties can lead to isolation, depression, loss of independence and mobility, and increased incidence of car accidents. Through understanding the impact of Parkinson disease on mechanisms underlying attention and multi-limb control, training and rehabilitation programs can better focus on the needs of drivers with Parkinson disease. The proposed study aims to address this need by taking measures of simulated driving at one point in time. Subjects with PD are tested at a single time point when they are at their "best" point in their day and on another day when they are at their worst and are about to take their next dose of medication. Healthy age-matched subjects are not taking anti-parkinson medication so are tested at only one point.
The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.
This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.
The study aims to identify neural locus critical for dual-task walking (walking and talking) in individuals with stroke. To achieve this aim, the investigators apply repetitive transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the effects of brain stimulation on dual-task walking speed.
The tDCS \& Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls.
The primary aim of the proposed project is to characterize dual tasking (DT) deficits to improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of these findings. This phase will involve creating a clinical intervention based on the objective information gathered the CAREN system. The intervention will take place 3x/week for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2) Single task group (N=10). Outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.
The first goal of this study is to examine the extent to which the inclusion of dual-task practice to standard balance rehabilitation results in greater benefits to dual-task ability. The second goal of this study is to examine the extent to which the addition of cognitive training following balance rehabilitation results in greater benefits to dual-task ability.
Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Unfortunately, current rehabilitation practice for stroke fails to adequately address dual-task limitations; individuals with stroke continue to exhibit clinically significant dual-task costs on gait at discharge. As a result, many stroke survivors are living in the community with residual deficits that may increase disability in the real world and lead to falls with devastating consequences. To address this issue, the proposed study investigates the efficacy of dual-task gait training on attention allocation and locomotor performance in community-dwelling stroke survivors. Because walking in the real world often requires time-critical tasks and obstacle avoidance, the investigators will test the impact of dual-task gait training on cognitive-motor interference during walking at preferred speed and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The investigators will also evaluate the effects of the intervention on community reintegration and participation (Aim 3).
The purposes of this study is to determined the effects of instrument applied spinal manipulative therapy upon dual-task performance involving complex postural and cognitive task.
The purpose of this research study is to assess the effects of dual-task training using a dynamic balance task and an auditory reaction time task on dual-task performance in healthy young adults and to assess the cortical activity within the prefrontal and sensorimotor cortices in response to dual-task training using functional near infrared spectroscopy (fNIRS).
The primary objective of this new line of research is to test whether augmenting sensory information from the legs, using Walkasins sensory neuroprosthesis, can enhance performance of a complex walking task in older adults with foot sensory impairment. The overarching hypothesis is that Walkasins will enhance the automaticity and reduce cognitive demand of walking in older adults with foot sensory impairments, as measured by reduced prefrontal activity, decreased dual-task costs, and lower gait variability.
This project involves two sub-parts: Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms of Multiple Sclerosis. Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis. Each study involves a 2-arm, Phase-1, randomized controlled clinical trial to evaluate the effect of FBI on physical, cognitive function, and daily living among people with MS (PwMS). Study 1 is conducted in a lab setting, while Study 2 is conducted at home with additional safety measures. A total of 150 people with multiple sclerosis will be recruited and telephone screened, with an expected enrollment of 120 (60 per phase). After in-person screening, 96 eligible participants (48 per phase) will undergo pre-training assessment and randomization into FBI or Stretching groups. Training sessions will occur twice a week for four months. Anticipating a 15-17% attrition rate, the target sample size is 80 (40 per phase) for completion of the study. Post-training assessments will be conducted after four months to evaluate FBI's impact on physical and cognitive functions. This evidence-based protocol, previously successful with neurological and older adult populations, intends to provide a low-cost, safe, and effective intervention for PwMS in clinical and community settings, including rural areas.
If a subject agrees to participate, the primary investigators will collect some basic information including age, height, and weight. Intake of some general questions regarding health will be performed and each subject will complete some tests that measure walking speed, cognition, and balance. During these tests participants will be asked to stand from a chair, walk up \& down a staircase, walk over objects in a forward, backward, and sideways directions, walk around objects in forward and backward directions. After completing those tests, participants will be asked to repeat them while doing another task such as counting out loud, naming objects, or passing an object from one hand to another.
The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is "remote" (completed at home, or location of choice), utilizing either one's own equipment ("bring-your-own-devices" BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).
The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is "remote" (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.
In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. This is a four-phase feasibility study in older, ambulatory adult participants at risk of falling due to a loss of balance (participant faller, PF) together with a willing and able participant administrator (PA) that is available during weekdays to administer tES to the PF. Phase 1 is focused on the development and refinement of our training materials for home-based tDCS (transcranial direct current stimulation) for PF/PA pairs. The objectives of this phase: 1. Identify areas of confusion and challenges for older adults. 2. Refine our training materials to accompany the home-based tDCS system. In Phase 2, the investigators will complete a pilot trial in 12 PF/PA pairs to assess the feasibility of deploying home-based tES in larger clinical trials, and to prepare for the development and implementation of such trials. The objectives of this phase: 1. Determine the mean/range number of visits needed for in-person training. 2. Compliance and retention with the study protocol. 3. Safety/side effects of home-based tES, as compared to previously established laboratory-based tES data. The investigators hypothesize that adult PAs are able to successfully administer home-based tES to PFs. The investigators also expect that PF/PA pairs will exhibit excellent adherence to the intervention and that the prevalence and severity of reported tDCS side-effects will be similar to that observed in previous laboratory-based studies. In Phase 3, the investigators will complete a pilot trial in up to 18 PF/PA pairs; i.e., those who have previously successfully completed either Phase 1 or Phase 2. The study objectives/aims for Phase 3 are: 1. Further explore compliance and retention with the study protocol over a longer time period 2. Identify safety/side effects of home-based tES over a longer time-period as compared to previously established laboratory-based tDCS interventions. In Phase 3, the investigators hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will retain competence and compliance with administration over a longer period, up to 1 year. In Phase 4, we will complete a pilot trial in up to 18 PF/PA teams; those who have previously successfully completed Phase 3. The study objective/aims for Phase 4 will be to: 1. Identify Safety, effectiveness and adherence to home-based tES over longer period of time as compared to previously established laboratory-based tES interventions. 2. Further explore the proof of Concept for the home-based tES interventions In Phase 4 we hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will adhere with the study protocol over a longer period of time, up to 3 years.