50 Clinical Trials for Various Conditions
The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. The comprehensive approach includes biofeedback-based gait training and aerobic exercise intensity-based gait training.
This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by randomization. Participants will be exposed to 2 types of biofeedback interfaces: * newly developed game-based interface (projector screen display) * traditional, non-game interface
The study is a prospective interventional study to assess the changes in corticospinal excitability and spinal reflex excitability of in response to rehabilitative strategies and protocols that are commonly used during physical therapy treatment of gait disorders among post-stroke subjects. As part of this protocol, 55 individuals with chronic stroke will be assigned to either Cohort 1 or Cohort 2, and will participate in 1-18 gait training sessions. If interested, study participants can also complete both study cohorts sequentially (with at least 3-weeks duration between switching from one cohort to the second). The study examines the effects among two cohorts of post stroke patients. Cohort 1 will participate in 18 sessions of fast treadmill walking plus Functional Electrical Stimulation (FastFES) and Cohort 2 will participate in 1-3 sessions of FastFES and fast walking without FES.
Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting spasticity.
The objective of this research is to test a passive shoe to correct gait in individuals with asymmetric walking patterns. This will be done in a clinic and within their own home. Individuals with central nervous system damage, such as stroke, often have irregular walking patterns and have difficulty walking correctly. Recent research has shown that using a split-belt treadmill can create after-effects that temporarily correct the inefficient walking patterns. However, the corrected walking pattern does not efficiently transfer from the treadmill to walking over ground. The iStride, formerly known as the Gait Enhancing Mobile Shoe (GEMS), may allow a patient to practice walking in many different locations, such as their own home, which we hypothesize will result in a more permanent transfer of learned gait patterns. To enable long-term use, our proposed shoe design is passive and uses the wearer's natural forces exerted while walking to generate the necessary motions.
The purpose of this study is to demonstrate the efficacy of intensive locomotor interventions early post stroke. An intensive locomotor training (LT) program will be compared to an active control, conventional physical therapy. It is proposed that an early and intensive stepping paradigm that is not typically employed early in physical therapy will lead to superior outcomes and improved community mobility. A randomized, blinded, controlled trial will test subjects with moderate to severe locomotor dysfunction in individuals post-stroke to compare walking-related outcomes after intensive gait training (including treadmill, overground, stair training, and skilled walking training) to outcomes after conventional physical therapy.
Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.
Over four million stroke survivors currently living in the United States are unable to walk independently in the community. To increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. This project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.
An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices.
In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.
This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.
The purpose of the project is to compare intensity (minutes in target heart rate zone) and steps per session across three gait training modalities, including body-weight supported treadmill training (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower extremity exoskeleton, between patients presenting with varying functional ambulation capacities in the inpatient setting. Additionally, the researchers will compare physical therapist (PT) burden across these modalities and patient functional presentation levels.
The purpose of this study is to compare two interventions currently used to improve gait and lower limb function in individuals with chronic stroke (i.e., high-intensity gait training and high-intensity gait training with functional electrical stimulation (FES)) with novel interventions based on the coordinated activity of multiple muscles, known as muscle synergies. To this end, the researchers will recruit chronic stroke patients to participate in training protocols according to the currently used rehabilitation programs as well as novel rehabilitation programs that provide real time feedback of muscle synergies using multichannel FES and visual feedback.
The purpose of this study is to identify neural muscle synergies of patients post-stroke and track them during an inpatient acute rehabilitation. To this end, the researchers will use an innovative approach based on the identification of large populations of motor units from recordings of surface high-density electromyography (HD-EMG).
The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.
Phase II of this study includes a pragmatic clinical trial which will take place at Northwest Rehabilitation Associates (NWRA) in Salem, OR to verify the efficacy of the system in a physical therapy clinic.
This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors. The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke. The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke. The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.
The long-term study goal is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The current project aims to address fundamental questions regarding the optimal methodology to deliver AGRF biofeedback during gait, and the feasibility and preliminary efficacy of AGRF progression protocols for improved gait patterns and gait function. The study objectives are to (1) evaluate the immediate effects of biofeedback training methodology on gait biomechanics; and (2) evaluate the feasibility and short-term effects on gait performance of a real-time biofeedback protocol incorporating progression criteria (similar to those employed during clinical rehabilitative training).
The purpose of this study is to determine the effects of daily feedback about physical activity (number of bouts of walking, duration of bouts, total walking distance, average and fastest walking speed) and walking average speed compared to feedback about walking speed only on walking-related outcomes during inpatient rehabilitation for stroke. For the first time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and return a summary to the participants at each site.
Previous studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for lost function. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce long-lasting gait restoration. Current gait training efforts are focused on either quality or intensity. They focus on gait quality often by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without focusing on the quality of their movements. These intervention paradigms generally fail to substantially impact community mobility. In this study, the investigators posit that exosuits can uniquely enable an integration of these paradigms (ie, high intensity gait training that promotes quality of movements). For this protocol, exosuits developed in collaboration with an industry partner, ReWalk™ Robotics will be used. To evaluate the effects of REAL gait training, the investigators will use clinical measures of motor and gait function, locomotor mechanics and energetics, and physiologic measures that may infer on motor learning. The spectrum of behavioral and physiologic data that we will collect will enable us to understand more comprehensively the gait-restorative effects of REAL. This study is a single-arm mechanistic clinical trial that will examine clinical and physiological factors that determine response to the intervention. This study will assist in informing best candidates and outcomes for future randomized controlled trials.
Previous studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for lost function. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce long-lasting gait restoration. Current gait training efforts are focused on either quality or intensity. They focus on gait quality often by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without focusing on the quality of their movements. These intervention paradigms generally fail to substantially impact community mobility. In this study, the investigators posit that exosuits can uniquely enable an integration of these paradigms (ie, high intensity gait training that promotes quality of movements). For this protocol, exosuits developed in collaboration with an industry partner, ReWalk™ Robotics will be used. To evaluate the effects of REAL gait training, the investigators will use clinical measures of motor and gait function, locomotor mechanics and energetics, and physiologic measures that may infer on motor learning. The spectrum of behavioral and physiologic data that we will collect will enable us to understand more comprehensively the gait-restorative effects of REAL.
This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.
The purpose of this study is to test the efficacy of a walking and balance training program designed to safely challenge and improve walking performance and balance in relation to walking speed, strength, endurance, and balance after traumatic brain injury (TBI). The aim and primary hypothesis of this research project is: Aim) Test and implement a new personalized intervention strategy, in addition to usual and customary care at an inpatient rehabilitation clinic, to improve patient outcomes with secondary conditions associated with impaired balance and walking that typically occur post brain injury. After validation of the locomotor Battery of tests, we will implement a personalized training strategy for individuals based on their battery profile. Hypothesis) Individuals training with this individualized protocol will demonstrate improved walking and balance outcomes and those with lesser pre-intervention impairment will improve at a greater rate than those with greater pre-intervention impairment.
The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.
The Ekso (Ekso Bionics) is a wearable exoskeleton that provides robotic support and walking assistance for patients with lower extremity paralysis. Research suggests that exoskeleton-assisted gait training is as effective as conventional gait training at improving walking outcomes and balance during both the chronic and subacute period following stroke (Goffredo et al., 2019; Molteni et al., 2017; Molteni et al., 2021; Nam et al., 2019; Rojek, 2019). Exoskeleton-assisted gait training during acute inpatient rehabilitation provides a means for patients to actively participate in gait training during the early and most severe stages of stroke recovery. Most acute inpatient rehabilitation facilities (IRFs) report a feasibility of 5-8 Ekso sessions during inpatient stays and demonstrate significant improvement from baseline (Nolan et al., 2020; Swank, 2020). Nolan et al. (2020) demonstrated that stroke patients receiving Ekso ambulated 1640 feet more than patients undergoing more conventional gait training techniques during inpatient rehabilitation, suggesting that the exoskeleton may offer additional benefit during this phase of recovery. Despite promising evidence, there have been no randomized controlled trials within the IRF setting. Because Ekso-gait training increases the number of steps patients can take, during acute inpatient physical therapy (PT), the investigators hypothesize that patients who participate in Ekso-gait training will demonstrate quicker improvements in balance, gait speed, endurance and independence in functional ambulation during their stay in the IRF. In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or Ekso-gait training therapy. Meaningful clinical benchmarks for balance and walking will be assessed using the Berg Balance Scale (BBS) (Alghadir, 2018; Moore, 2018), the 10 Meter Walk Test (10MWT) (Bowden, 2008; Moore, 2018), the Six Minute Walk Test (6MWT) (Kubo et al., 2020; Moore, 2018), and Functional Ambulation Category (FAC) (Mehrholz, 2007). Achieving these benchmark scores are associated with several positive outcomes, including increased ability to ambulate in the community and reduced risk of falling (Alghadir, 2018; Bowden, 2008; Kubo et al., 2020). The investigators also hypothesize that patients in the Ekso cohort will report greater value/usefulness when compared to patients receiving standard care.
The ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott \& White Institute for Rehabilitation (BSWIR).
The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
To test the usability and effectiveness of a robotic device, called the Robotic Gait Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2) patients with stroke with gait abnormalities secondary to impaired knee function.
The purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training.
Stroke is a major cause of disability, with 2-3% of Americans reporting stroke related impairments (Tsao 2022). Following stroke, over half of Medicare patients are discharged to post-acute care facilities or receive home-based health care (Tsao 2022). Inpatient rehabilitation guidelines are lacking, with many interventions based on research of patients with chronic stroke. There is great need for randomized clinical trials during the early subacute period (Bernhardt 2017, Jordan 2021). Clinical practice guidelines recommend high intensity gait training (HIGT) for ambulatory patients with chronic stroke (Hornby 2020). Outpatient HIGT protocols incorporating variable stepping demonstrate equivalent effectiveness to forward stepping protocols (Hornby 2019) and have yielded superior results to lower intensity therapies (Hornby 2019, Hornby 2016). Research suggests that HIGT with variable stepping is feasible during inpatient rehabilitation (Hornby 2015, Moore 2020). Pre-post studies suggest that participation in HIGT during inpatient rehabilitation yields greater improvements in walking without an increase in adverse events. (Moore 2020). Despite this, there are no randomized controlled trials evaluating HIGT in the inpatient setting. The subacute phase of stroke recovery may be a critical time for neuroplasticity (Dromerick 2021). Not only might rehabilitation interventions be more effective when initiated earlier (Biernaskie 2004, Dromerick 2021) but because inpatient rehabilitation represents the transition from hospital to home, interventions during this timeframe have the potential to improve discharge disposition, enhance quality of life, and reduce utilization of post-discharge services. In this randomized controlled study, investigators will determine how participation in HIGT during inpatient rehabilitation affects balance, ambulation, and quality of life after 14 and/or 21 days of inpatient rehabilitation, and 8 weeks post-discharge. Investigators will also determine if HIGT reduces health care burden with a cost-effectiveness analysis.