88 Clinical Trials for Various Conditions
The goal of this study is to assess the feasibility of utilizing a telehealth rehabilitation platform to increase patient access for individuals who have undergone orthopedic surgery. Patient participants will be seen via telehealth until they are able to be seen by an in-person physical therapist of their choice. Provider participants will be the physical therapist who are providing physical therapy services through the telehealth application. Data collection: Patient and provider post surveys Home program and scheduled visit compliance rate Healthcare information in keeping with Stand of care physical therapy practices Feasibility criteria will be assessed to determine whether this modality improves physical therapy access for patients living in rural areas.
The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization. The investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.
Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service. Through this prospective, randomized controlled trial, the investigators aim to demonstrate the safety and efficacy of PCTR in a clinically diverse population of children and adolescents with heart disease.
Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability, transportation, and missed work time leading to greater rates of LBP-related disability and opioid consumption. With the rapid emergence of digital treatment approaches to physical therapy (i.e., telerehabilitation), access could be improved by reducing or eliminating many barriers that patients report; however, it is unclear how to appropriately incorporate digital treatment approaches into existing health care models. The investigators propose a prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-informed telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery (physical therapy telehealth visits or psychologically informed physical therapy telehealth visits) based on the patient's psychosocial risk of poor outcomes.
Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.
The goal of this pilot randomized clinical trial was to assess the feasibility of telerehabilitation (TR) for patients with Parkinson\'s Disease (PD). The main questions it aims to answer are: 1. whether the recruitment to such a study will be successful and the satisfaction of both participants and clinicians will be good. 2. Clinical effectiveness of TR for patients with PD was also explored. Participants were randomized to 3 groups : 1. Clinic+TR. 2. TR-only group and 3. A usual control group. Results were compared between the groups.
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
The use of reverse total shoulder arthroplasty (RSA) has increased dramatically in the United States in recent years. The importance of postoperative physical therapy in the setting of anatomic total shoulder is well understood and explored in the literature. The literature describing postoperative physical therapy for RSA, however, is scarce and somewhat limited to the field of physiatry in the form of clinical commentary on rehabilitation programs.In addition, the use of formal in-person therapy versus physician-guided home therapy has been explored in total shoulder arthroplasty, demonstrating similar post-operative range of motion and patient-reported outcome (PROs) between groups. Furthermore, previous research into "telerehabilitation" or remote physical therapy through a video-based platform has demonstrated noninferiority in outcomes in multiple orthopedic procedures, including hip and knee arthroplasty and reverse shoulder arthroplasty. Telehealth therapy has not yet been formally evaluated in a randomized approach for reverse or anatomic total shoulder arthroplasty. Given the ongoing COVID-19 pandemic, emphasis on social distancing, and multiple states having issued "stay at home" orders, a study into the effectiveness of telerehabilitation on current postoperative outcomes in shoulder arthroplasty may influence postoperative management and allow patients an alternative route for rehabilitation that allows more flexibility in completing, as well as limits potentially extraneous travel and exposure. The project will be a randomized control trial evaluating formal in-person physical therapy versus telerehabilitation after shoulder arthroplasty. Patients who undergo shoulder arthroplasty will complete either formal physical therapy or telerehabilitation postoperatively. The aim will be to identify any differences in shoulder range of motion, pain, or patient-reported outcome measures (PROs) between those who complete in-person physical therapy versus telerehabilitation therapy.
This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via telerehabilitation is as good as standard in-person care for these individuals. Long term outcomes including patient satisfaction, cost-effectiveness analysis, and functional status will describe the feasibility of telerehabilitation as a management intervention for this population.
This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI).
The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older Veterans and to preliminarily assess participant outcomes (physical activity, physical function, quality of life, loneliness) to the program.
Speech-language therapy is generally found to be helpful in the rehabilitation of aphasia. However, not all patients with aphasia have access to adequate treatment to maximize their recovery. The goal of this project is to compare the efficacy of telerehabilitation or Aphasia Remote Therapy (ART) to the more traditional In-Clinic Therapy (I-CT).
The purpose of this research study is to assess the feasibility of initiating telerehab in early stages after stroke during patient admission to an inpatient rehabilitation facility. Patients will complete 36 sessions of telerehab 6 days/week up to 8 weeks with a telehealth system provided in their hospital room and at their home. The system will include rehabilitation activities/exercises, education, and assessments to evaluate the patient experience and measure patient outcomes at the end of a 6-week course of telerehab.
Background and Purpose: Ankle fractures represent one of the most common fractures in North America. Surgical fixation is often required in the presence of dislocation or instability and has been shown to have a high rate of success. Following surgical fixation, physical therapy is commonly utilized to assist in regaining function. Advice alone has been shown to be non-inferior to traditional physical therapy for patients post-ankle fracture in two studies. The results of these studies have yet to be repeated in the US. It is the intent of this study to investigate the feasibility of a large clinical trial comparing the results of traditional physical therapy and an internet-based telerehabilitation program. Following surgical repair of ankle fractures, patients will be randomized to traditional rehabilitation or telerehabilitation. Telerehabilitation may represent an alternative patient option to traditional physical therapy following ankle fracture repair. The results of this study will inform the design of larger multi-site clinical trials investigating the effectiveness of telerehabilitation for this patient population.
This trial studies the impact of motivational strategies designed by the gaming industry on adherence to a home tele-rehabilitation program designed to improve hand function in persons with stroke. A growing literature suggests that the extended practice of challenging hand tasks can produce measurable changes in hand function in persons with stroke. Current health care delivery systems do not support this volume of directly supervised rehabilitation, making it necessary for patients to perform a substantial amount of activity at home, unsupervised. Unfortunately, adherence to unsupervised home exercise regimens is quite poor in this population. The investigator's goal is to assess the impact of several well-established game design strategies: 1) Scaffolded increases in game difficulty 2) In-game rewards 3) Quests with enhanced narrative. The investigator's will utilize these enhancements to study their impact on motivation to perform a tele-rehabilitation- based home exercise program, adherence to the program and changes in hand function. The proposed study will utilize a system of novel rehabilitation technologies designed to facilitate home exercise performance. Subjects will perform 3 simulated rehabilitation activities supported by a passive exoskeleton, an infrared camera and software that will allow subjects to exercise at home. The investigator's will investigate: 1) Differences in measures of motivation elicited by motivationally enhanced simulations and un-enhanced control versions.2) The impact of motivational enhancements on actual adherence to a tele-rehabilitation program in persons with stroke and 3) The impact of motivational enhancement on improvements in hand function achieved by these subjects. This proposal will address a critical gap in modern rehabilitation - adherence to autonomous rehabilitation programs. Patient participation in unsupervised rehabilitation is one of the assumptions underpinning our health care system. This said, no data collected to date supports that adherence is acceptable. The technology and methodology in this proposal are an important step towards leveraging extensive research and development done by the computer gaming industry into improved rehabilitation practice.
This study will evaluate the sustainability of pain and functional outcomes along with return to opioid use in a population of patients that successfully completed a comprehensive interdisciplinary pain rehabilitation program. In addition, this study will compare outcomes sustainability and return to opioid use between pain program graduates who receive post discharge self-management resources consisting of a DVD with videos of recommended flexibility practice (standard of care) or access to an online telerehabilitation platform that provides patients with access to the flexibility practice videos on a variety of telecommunication devices (e.g., computer, smart phone, tablet).
The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated Telemanagement) System as an adjunct to the current standard of medical care for patients with MS (PwMS). The individual patient with MS will be the unit of analysis. For each participant, the investigators will assess the effect of Home Automated Telemanagement (HAT) on functional outcomes, levels of disablement including impairment, activity and participation, socio-behavioral parameters, and satisfaction with medical care as described below.
The purpose of this study is to develop a home exercise program for patients 60 years of age and over who are deconditioned following their discharge from the hospital, or recruited from GLA outpatient clinics. The program will be designed to monitor and improve patients' exercise behavior through the use of home technology, such as text messaging monitors.
The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).
Stroke is a leading cause of long-term disability. Research has placed little emphasis on integrating care partners (CP) (family members) into the rehabilitation process without increasing negative care partner outcomes. The research team has developed and implemented a novel, web-based care partner-focused intervention (CARE-CITE) designed to foster problem-solving and skill building while facilitating care partner engagement during stroke survivor (SS) upper extremity practice of daily activities in the home setting. By providing a family-focused approach to rehabilitation interventions, this project will help develop more effective treatments that improve CP and outcomes after stroke.
The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities.
The goal of this pilot study is to investigate whether adding cognitive rehabilitation to an existing occupational therapy (OT) stroke telerehabilitation program will improve stroke survivors' functioning. The main question it aims to answer is whether this intervention improves cognition, participation, upper extremity use in real-world activities, and mood/quality of life. Participants will be asked to engage in an 8-week stroke tele-rehabilitation program (13 sessions), which includes both cognitive rehabilitation and OT for arm/hand function, and complete assessments before and after the intervention.
Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Furthermore, population-based studies suggest that between 50% and 80% of older individuals (aged 70 years and older) who perform normally on cognitive tests, report some form of perceived decline in cognitive functioning when asked. The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden, and therefore represents probable preclinical AD relative to other causes of SCD. Likewise, growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI, or AD, following the classic SCD-MCI-AD trajectory, with SCD increasing MCI risk 1.5-3 fold. Preventing Alzheimer's disease (AD) is arguably the most important approach to address the dementia epidemic worldwide because 99.6% of drug trials failed and no drugs can yet prevent, cure, or even slow AD. A treatment that delays the onset of AD by five years could save $89 billion in 2030.This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression. This study will use a randomized, 2-parallel group, trial design that is guided by the Consolidated Standards of Reporting Trials (CONSORT)and the SPIRIT checklist. We will randomize 104 community-dwelling older adults to one of two arms for 3 months: home-based (asynchronous telerehabilitation) Exergame (HbExergame) or home-based (asynchronous telerehabilitation) aerobic exercise (HbAEx). Randomization will allocate subjects on a 1:1 allocation ratio within each age stratum (65-74 and \>75), and will use permuted blocks of 8 and 4. We do not expect equal numbers of subjects in each age stratum, but want to balance the groups for each age. Investigators will be blinded to group assignment. All participants will be blinded to study aims and reminded as needed not to discuss their experiences with outcome assessors. Outcome assessors (also blinded to group allocations) will measure: 1) feasibility (attendance, adherence to exercise dose, systems usability scale), 2) preliminary cognition: fluid cognition \[primary outcome\], attention, episodic memory, and processing speed \[secondary outcomes\] using the NIH Toolbox cognition battery and aerobic fitness \[VO2peak and 6-minute walk distance\], and 3) blood neurotrophic biomarkers.
To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)
The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.
One goal of this research is to conduct a non-inferiority trial of telerehabilitation versus in-office care to provide follow-up training to individuals with low vision to enhance their quality of life by using magnification devices and/or visual assistive mobile apps for important daily activities, such as reading and/or other valued tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, which can be essentially eliminated with telerehabilitation. Another goal of this project is to determine whether significant changes in environmental data collected by Bluetooth low energy beacon sensors can be used as a solution to monitor and indicate when low vision patients' have abandoned the use of their magnification devices, which has the potential to substantially enhance patient management by providing timely low vision rehabilitation services.
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke. The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.
The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.
Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans. Substantial advances have been made in early detection through screening and treatment. The longevity of Veterans following lung cancer diagnosis and treatment has increased. Following treatment however, many Veterans experience increased symptom burden, particularly in shortness of breath, fatigue, and fear/anxiety about lung cancer, and impairments in physical and psychosocial functioning. Rehabilitation services are needed to address these survivorship challenges. This study will evaluate multi-targeted telerehabilitation with Veterans following lung cancer treatment, with goals to reduce symptom burden, improve physical and psychosocial function, and enhance health-related quality of life. This research will also develop the career of a physician researcher to acquire expertise in rehabilitation for many Veteran survivors of lung and other cancers.