12 Clinical Trials for Various Conditions
Acquired Brain Injury (TBI) is a serious medical and health problem in the US. Individuals with an acquired brain injury due to stroke and Traumatic Brain Injury (TBI) commonly suffer from upper extremity physical impairments that persist even after years of injury; these deficits are attributed to the damage to brain structure and changes in structural and functional connectivity. Although the conventional rehabilitation approaches are helpful in assisting motor recovery often there is a complaint of fatigue due to the repetitive tasks and also, nearly half of the ABI survivors do not regain their ability to use their arms for daily activities. To address this issue, Dr. Shenoy's proposed study will investigate the combined use of individually targeted non-invasive brain stimulation and music-assisted video game-based hand exercises to achieve functional recovery. Further, the project will also investigate how the intervention modulates brain activity (recorded using EEG) in terms of brain connectivity before- and after the -intervention. In the end, this study will allow us to understand the cortical dynamics of ABI rehabilitation upon brain stimulation. Extending further, this could pave the way to advance the knowledge of behavioral and neural aspects of motor control in patients with different types of neuromuscular disorders.
This study aims to assess differences in choice of treatment (and the rationale behind it), physical function, pain intensity, satisfaction, and decision regret between orthopedic patients who review a decision aid during their visit and those that do not. Decision aids for 23 different conditions are included.
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk group through the use of a movement assisting device.
To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.
The study aims to inform the subsequent large-scale clinical trial focused on using telerehabilitation techniques and technologies to improve upper limb function and quality of life.
This study is designed to investigate how musical patterns (e.g., patterned sensory enhancement, PSE) and non-invasive brain stimulation (e.g., transcranial direct current stimulation, tDCS) are effective to improve functional upper extremity performances in patients with corticobasal syndrome (CBS). 20 individuals with CBS will be randomly assigned to either PSE group (n= 10) or PSE+tDCS (n=10) group. Both interventions are 30 minutes long, twice a week for three weeks (a total of 6 sessions). Participants' self-reported and measurable outcomes including upper extremity function, kinematic quantities, quality of life, mood, cognitive level, and brain activity (e.g. electroencephalography, EEG) will be assessed in the baseline, pre- and post- each session, and follow-up phase. This study seeks to assess the possibility that music-based intervention and non-invasive brain stimulation may improve outcomes in CBS patients for patients' non-invasive but cost-effective rehabilitation settings in the future.
The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide.
The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.
Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network. This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury. The interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.
Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.
Many stroke survivors exhibit persistent upper limb motor deficits and a non-functional upper limb. There is some promising information that suggests motor learning (ML) in conjunction with functional electrical stimulation (FES; surface FES; nothing implanted; use of a commercially available system) of wrist/finger muscles can significantly enhance the functional level of the upper limb. There have been promising studies showing that some subjects in the chronic phase (greater than 6 months after stroke) responded favorably to combination FES and ML (FES ML). In our pilot studies, FES ML for those in the chronic phase (\>12 months) produced statistically significant functional recovery. FES was applied using a commercially available, two-channel FES system, with electrodes applied to the surface of the skin (non-invasive). But if upper limb dysfunction is not immediately treated, that is within the sub-acute phase (less than 6 months) following stroke, the following problems can develop: contractures and other soft tissue changes; chronic pain; and ingrained, abnormal, non-functional movement patterns. The more long-standing these symptoms are, the more resistant to treatment they become. Therefore, it is important to provide promising interventions prior to the onset of chronic symptoms and dysfunction. Those in the sub-acute phase after stroke should be provided with FES ML, in order to more completely restore function for a greater number of stroke survivors. Specific Aims and Hypotheses The goal of this pilot study is to test the feasibility of the proposed treatment in the sub acute phase following stroke. HYPOTHESIS. FES ML for 3hrs/day, five days/week, for 12 weeks will be feasible to implement in the sub-acute phase following stroke (2 -24 weeks). Study Design a. Specific Procedures This is a pilot study to test the feasibility of using FES ML for upper extremity rehabilitation in a sub-acute stroke population. It is a randomized, controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The control group will receive standard care for upper limb rehabilitation consisting of passive and active exercise, stretching, bracing, and use of adaptive devices. The experimental group will receive the experimental intervention in addition to their standard care. CONTROL GROUP INTERVENTION. The control group will receive the standard medical care prescribed by the primary physician and covered by the subject's health care policy. Standard care will include: soft tissue mobilization; assisted motion exercise; active motion exercise; resistive exercise; task practice; use of assistive devices; and modality applications conventionally prescribed. FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week. The subjects will be present for a fourth hour each day, which will be used for breaks and rest periods that will be interspersed throughout the intervention time. The treatment duration is derived from prior work. We will stimulate muscles in a number of configurations including: wrist extension and finger extension; wrist extension and finger flexion; and wrist extension, finger flexion, and thumb abduction and opposition. Motor learning will include the performance of functional task components and full task practice during the use of FES. FES will be triggered by the patient, the treating therapist, or it will be automatically sequenced by the device according to alternate channel activations, with timings pre-set by the treating therapist. MEASURES. Data will be collected at weeks 1, 6, 12 (end of treatment), and 6 months after the end of treatment. Population The subjects will be sub-acute stroke survivors (2-24 weeks after stroke).
The purpose of this study is to investigate if a person with weakness or paralysis in one or both arms, can use the NuroSleeve combined powered arm brace (orthosis) and muscle stimulation system to help restore movement in one arm sufficient to perform daily activities. This study could lead to the development of a product that could allow people with arm weakness or arm paralysis to use the NuroSleeve and similar devices to improve arm health and independent function.