157 Clinical Trials for Various Conditions
In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards.
The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system. Participants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.
The purpose of this research is to learn about practice conditions that may benefit stroke survivors when learning to use their more affected arm to perform a task. Participants will be randomized into two groups. Experimental and control groups will differ by one practice variable that will not be disclosed until completion of testing procedures. Participants will practice a motor task using both their more and less affected arms for two consecutive days. A Pre-Test will be administered on Day 1 before the training begins. Immediate Transfer of Learning will be administered on Day 2 after the completion of training. Delayed (24-hour) Retention and Transfer Tests will be administered on Day 3.
This study aims to examine the acceptability of patients and occupational therapists in following a mental practice protocol and examine the effects of mental practice with individuals with severe upper extremity hemiparesis (weakness) following a stroke. Mental practice is an adjunctive rehabilitation therapy that involves thinking about a motor task without actually moving. Research has shown that mental practice is a safe and feasible intervention that is effective in improving arm movements after a stroke. Patients in the study will participate in audio-guided mental practice, five days a week for two weeks, completing the following tasks: wiping a table and picking up a cup. The patients' ability to move their affected arm will be measured before and after the study to determine the effect of mental practice. Patients and occupational therapists will complete a survey to determine their feelings about performing or facilitating mental practice. The authors hypothesize that the majority of patients and occupational therapists will find mental practice to be feasible/acceptable for the recovery of the affected arm. Furthermore, we anticipate the majority of patients that complete the mental practice protocol will demonstrate improvements in their arm movements.
The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.
The Occupational Therapy Department at Boston Children's Hospital is teaming up with MGH Institute of Health Professions to explore the benefits of using robot assisted therapy (Amadeo) and a problem solving approach (Active Learning Program for Stroke) to achieving functional goals for children ages 7-17 years old that have hemiparesis. The hope is to help participants make gains in both hand/arm skills and progress in everyday activities such as self-care, play, school and work. Participation will look like regular therapy with sessions 3 times weekly for 8 weeks. Each visit will include time for games on the Amadeo and time spent problem solving current activity challenges for each child. Families are encouraged to participate.
Modified constraint-induced movement therapy (mCIMT) has been successfully used with children who have hemiplegia (weakness or paralysis on one side of the body.) mCIMT uses a removable cast during treatment and home exercise programs. It has been found that mCIMT can improve use, strength and coordination of a child's affected hand, and may also help improve speech and language skills. The goal of this project is to investigate whether combining mCIMT with speech therapy will enhance speech outcomes in children with cerebral palsy.
The Baby CHAMP Study is a multisite clinical trial funded by the National Institutes of Health that is examining the the use of constraint-induced movement therapy (CIMT) for infants and toddlers as a effective treatment, since there have been no randomized control trials (RCT) for the age range as well as monitor the stress levels as related by self-report of parents or biological indicators. Infants and toddlers who meet study eligibility requirements at one of the three clinical sites (Charlottesville, VA, Columbus, OH, and Roanoke, VA) will be invited to enroll, and their parents will be provided all necessary paperwork along with informational documentation.
Hemiparetic cerebral palsy influences motor function in children during development and throughout their lifetime. The deficits one sees are the result both of the congenitally induced brain lesion and the subsequent plasticity that can impair function of the surviving neurons in the damaged brain. Many current treatments have limited influence on children's neurorecovery. Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to encourage use of the affected limb has shown promise, yet with new technology revealing the potential to directly influence the brain, there is an urgent need to study the synergy of combined techniques. Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the potential to act synergistically with CIMT to influence neurorecovery. Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the influence of this intervention on improved motor outcomes in children with cerebral palsy. The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS wherein those children who receive the combined intervention will reveal no major adverse events, yet improved hand function and cortical excitability. To Note: In addition to the combination of NIBS with CIMT, we also investigated the combination of NIBS with another form of motor intervention, bimanual, or two-handed, training. During bimanual training, children engage both hands in movements. The goal of bimanual training is to teach children how to most effectively use their hands cooperatively. During bimanual training, children play with games and toys that require the use of both hands. Children also practice activities of daily living that require the use of both hands, such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot study and no randomization. (Burke Medical Research Institute partnered with Columbia University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)
What is the CHAMP Study? The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health that is comparing the efficacy of alternative therapies for young children with unilateral spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility criteria at one of the three clinical sites (Roanoke, VA; Charlottesville, VA, and Columbus, OH) will be invited to enroll, and their parents will be provided all necessary paperwork along with informed consent documentation. Assignment to one of the alternative therapy conditions will be random. Participation in the study includes assessment of each child prior to treatment, close monitoring of the child's progress during treatment, and post-treatment evaluation at the end of therapy, as well as, 6 and 12 months later. Parents will have an active role in the project, both observing their child during therapy sessions and then engaging in home-based activities that allow the child to practice and extend new motor skills. There will be no charge for the therapy provided. What are the therapies being tested? In the past decade or so, a new form of therapy for children with hemiparetic cerebral palsy was developed and has shown to produce positive changes in individual children and in small clinical trials (e.g., DeLuca, Echols, Ramey, \& Taub, 2003; DeLuca, Echols, Law, \& Ramey, 2006; Case-Smith, DeLuca, Stevenson, \& Ramey, 2012). The therapy is named Constraint-Induced Movement Therapy (CIMT) and refers to a multi-component form of therapy in which the child has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity. Traditionally, CIMT therapy dosages have been high - often lasting many hours per day, 5 days a week, for 4 consecutive weeks. There are important clinical and scientific questions that need to be answered about the effects of different dosage levels and about different types of constraint on the child's more functional (less impaired) arm and hand. This study will be the first that will directly compare different amounts of therapy and different types of constraint to evaluate what "works best" for young children. The therapy is very play-like and engaging for children, and no negative effects of casting or the high dosages have been detected in previous clinical trials. Who is eligible: Children between 2 and 8 years of age with a diagnosis of unilateral spastic cerebral palsy or hemiparetic cerebral palsy. Children must be relatively healthy, not currently receiving Botox (or other similar medications), and able to understand simple communication and instructions. In advance, the treatment will be explained in detail to parents and a written protocol available to share with the child's physician and other current therapist for review. During the one month of treatment, children will not receive other forms of physical or occupational therapy.
The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.
Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing arm disability and increasing function, thereby improving outcomes and health, reducing care costs, for community dwelling patients with stroke-induced hemiparesis.
The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis. The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses: 1. tDCS will not produce a major adverse event, including seizure activity. 2. No change in paretic or nonparetic hand function or cognitive status will occur.
The purpose of this project is to assess the effects of four weeks of mirror-box training on weakness of one arm secondary to stroke. Primary measures are function and strength. Secondary measures will evaluate muscle tone, flexibility, and the subject's perception of their everyday function and improvement. Research Hypothesis: For chronic upper limb hemiparesis secondary to stroke, four weeks of mirror-box training with movement of the unaffected limb only results in a mean increase of 10 points on the Fugl-Meyer Test of Motor Recovery (Upper Extremity).
The purpose of this study is to assess the safety and effectiveness of cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis affecting the upper extremity following a stroke.
The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors. The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.
Our overall goal is to develop therapeutic interventions to improve upper-limb motor function in hemiparetic persons based on an improved understanding of the mechanisms responsible for its loss and recovery. We intend to rigorously evaluate the efficacy of these interventions with clinical trials, and to study the mechanisms by which these interventions affect motor recovery. In this proposal, we will use a controlled, randomized, double blind clinical trial to study the effects of shoulder and elbow strength training in subjects in the subacute phase of recovery following stroke.
TRACTs (DeconsTructing Post StRoke HemipAresis for PreCision NeurorehabiliTation) is a single timepoint study that aims to deconstruct post-stroke deficits of the upper extremity into distinct components and relate these components to brain anatomy and physiology.
The primary purpose of this study is to establish that application of a Sequential Compression Device (SCD) and lower extremity (LE) sleeve applied to a hemi-paretic upper extremity is safe.
The purpose of the study is to determine the best treatment for the arm that has been affected by a stroke. The investigators plan to determine if the arm affected by a stroke will improve with a combination of motor priming and motor training. Motor priming provides a warm up for the brain so that the brain and body will better respond to treatment. There are two types of priming in this study. One is called bilateral motor priming which involves using both hands. Bilateral priming requires that the individual make continuous wrist movements in a low-tech gadget called the Exsurgo primer, a piece of equipment in which each hand goes between two plates that are connected together so that the stronger wrist moves the weaker wrist in and out at the same time. The second type of priming includes use of low intensity stimulation for your affected arm. The investigators expect the bilateral priming group will have more improvement. The study team anticipates enrolling approximately 76 individuals with stroke at Northwestern University and Shirley Ryan AbilityLab into this study. Each participant will have 24 visits. Nine visits will be for evaluation and fifteen for therapy. Each visit will be two to three hours depending on the type of visit and tests being done. Participants who are eligible and want to participate in this study will be randomized (selected by chance) to one of the two groups. The possible groups are: 1) bilateral priming plus motor training and 2) electrical stimulation priming and motor training. Participants are not blinded. Evaluation sessions consist of three separate days of testing and will occur at three time points: (1) before treatment starts; (2) after treatment is completed; and (3) 8 weeks later (follow-up evaluation: visits 22-24). There are three motor assessments, the Neuro-QOL (short form), and an evaluation of cortical excitability using TMS. After a stroke, there is often an imbalance of excitability between the affected and less affected parts of the brain. The imbalance will be measured using Transcranial Magnetic Stimulation (TMS), a technique used in neurorehabilitation research. TMS will not be used for treatment. There will also be a grip termination evaluation. This test will determine how long it takes to relax the affected hand after gripping an object.
This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.
This study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. The intention is to understand the effects of priming on upper limb training post-stroke.
The purpose of this study is to determine whether Repetitive Transcranial Magnetic Stimulation (rTMS) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (\< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy.
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration.
Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation. Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages (\>6 months) post-stroke. This study will determine which patients are best able to benefit from this therapy approach, and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training. The results of this study will help to improve rehabilitation and quality of life for disabled Americans.
The purpose of this study is to improve control of myoelectrically-controlled advanced orthotic devices (an exoskeleton device that use the body's muscle signals to drive movements of a robotic brace) by using advanced predictive decode algorithms, and the use of high count (\> 8) surface electromyographic (sEMG) electrodes.
Chronic stroke survivors suffering from weaknesses or movement difficulties in their hand/arm are provided a system to aid in at-home rehabilitation for 6 weeks. This rehabilitation system includes a headband that measures and provides feedback from the brain during rehabilitation, together with tablet-based software. Throughout the 6 week rehabilitation period (as well as in a follow-up session 1 month afterwards) several assessments are taken to understand the effect of this rehabilitation on participant's movement abilities, as well as their brain activity.
The ArmeoSpring device is an exoskeleton (3 joints and 6 degrees of freedom) with integrated springs. The investigators hypothesize that 3 days of training for 6 weeks with the Hocoma Armeo Spring device will be efficient and more effective than one on one ArmeoSpring therapy.