View clinical trials related to Spinal Cord Injuries.
Filter by:The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures.
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 12 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy. Participating subjects will be randomly assigned to one of two treatment groups: 1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation. 2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation). For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm. At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 12 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
Persons with disabilities (PwD) commonly experience fatigue, which often negatively impacts their everyday lives. Management of this symptom can be challenging. Satisfaction with current interventions to manage fatigue is low among PwD and there is a desire for more personalized approaches. The purpose of this study is to develop and test a fatigue self-management intervention using mobile phones that is personalized to each person's needs.
Spinal cord injuries (SCI) are among the most debilitating conditions an individual can sustain with the estimates of SCI incidence in the United States at 12,000 new cases per year. The loss of innervation to the tissues muscle below the level of the lesion results in reduced physical activity which leads to an array of secondary complications including muscle atrophy, cardiovascular and metabolic disease, obesity and vascular dysfunction. This further leads to exercise intolerance, reduced quality of life and depression. Although current rehabilitative programs focus on improving muscle strength in this population, the efficacy of these programs is challenged by the injury related motor impairment, which limits the exercise intensity and subsequent positive muscular adaptations. Therefore, development of an exercise program that promotes maximal muscular adaptations to light intensity exercise could greatly improve the efficacy of rehabilitation in the SCI population and help restore functional capacity and quality of life for these individuals. Blood flow restriction (BFR) exercise has shown tremendous promise for improving muscle size and strength in a variety of healthy and clinical populations, however the benefits of BFR exercise for those with SCI has not been established. Thus, the purpose of this Merit proposal is to conduct a comprehensive study that explores the benefits and risks of BFR exercise in the incomplete SCI population. In general individuals with chronic incomplete SCI will be recruited to partake in two 8-week training periods (20 sessions) that involve traditional knee extension/flexion exercise or knee extension/flexion exercise with blood flow restriction. There will be a series of measurements before and after the 8-week intervention to look at changes in muscle and vascular function. Specific Aim 1 will determine how the 8-weeks of BFR exercise influenced muscle strength (Biodex isokinetic dynamometer), muscle cross sectional area and volume (CTscan) and fatigue resistance. Specific Aim 2 will determine how this novel 8-week training intervention impacts peripheral vascular function. Specifically, changes in nitric oxide mediated endothelial function will be determined through tests of flow mediated dilation, changes in endothelial function of the microvascular network will be determined through assessments of reactive hyperemia and changes in arterial stiffness will be determined through measurements of pulse wave velocity. Specific Aim 3 will focus on the safety of BFR exercise for the SCI population. Those with SCI are at greater risk for thrombosis and DVT compared to able bodied individuals. Although unlikely, the introduction of temporary blood stasis during BFR exercise might augment this risk. Thus, the third aim of this study will be to determine changes in innate immune activation and thrombosis risk. Specifically, blood will be collected at multiple timepoints throughout the training intervention and analyzed for hypoxia-inducible factor 1-alpha, neutrophil extra cellular traps (which act as prothrombotic scaffolds), neutrophil-platelet aggregates and inflammatory cytokines. Ultimately, if the improvements in muscle and vascular function following BFR resistance exercise is greater than the traditional resistance exercise often performed in rehabilitation settings, without increasing risk for DVT, it should be incorporated into the long-term rehabilitation programs for Veterans with SCI.
Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds. Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use. Methodology: All participants with chronic ischemic wounds treated at LSCDVAMC will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1)Age less than 18 years and (2)Pregnancy. Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.
This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach. Participants may qualify for the study if they are male or female 18-75 years old, are at least 1 year after original injury, have injury at C2 to C7 level, and dependent on mechanical ventilation to help them breathe. Additionally, they need to be able to attend up to twice weekly testing sessions for up to 21 months.
Falls are a health crisis that cost health care systems billions of dollars/year. This crisis is especially relevant for individuals living with incomplete spinal cord injury (iSCI); 78% fall at least once annually. In able-bodied individuals, falls are prevented by taking reactive steps; however, these reactions are impaired after iSCI. Research in stroke and geriatric rehabilitation showed that reactive balance training (RBT), which targets reactive stepping, prevents falls. We developed a modified version of RBT for the iSCI population. RBT resulted in fewer falls post-training compared to dose-matched, conventional balance training. However, only those who were able to take a step independently and without upper limb support were able to participate in RBT, limiting the applicability of this promising fall prevention method. To address this limitation, we will integrate functional electrical stimulation into RBT (RBT+FES). Our study aims to provide a preliminary evaluation of the efficacy of RBT+FES in participants with chronic, motor iSCI. We will complete a pilot randomized clinical trial (RCT) with 22 participants with iSCI. Participants will be randomly allocated to RBT+FES or to RBT alone (i.e. without FES). They will complete 18 training sessions over 6 weeks (3 sessions/week). Clinical and biomechanical assessments of balance, strength and proprioception will be completed before training, immediately after training, and six months post-training. Falls will be monitored for six months after training through an online survey and regular phone calls. Performance on clinical and biomechanical measures and fall data will be compared between groups. This research will inform the need for, and design of, a larger RCT, and has the potential to transform fall prevention after iSCI.
The loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The overall objective of this study is to demonstrate that epidural stimulation may be a method for improving stepping, standing and bladder function in individuals with spinal cord injury. With the use of epidural stimulation, the investigators propose to investigate how well the participant can stand and walk and how well the participant's bladder can store or hold urine as well as void or empty urine. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that are unable to stand or walk and have impaired bladder function.
Respiratory failure and dyspnea are common in spinal cord injury (SCI), and in acute situations, any spinal cord lesion above T11 can cause abnormal respiratory function and impair the airway clearance. Although surgical decompression is one of the key early neuroprotective therapies, surgery and general anesthesia disrupt many aspects of respiratory function and may cause a series of postoperative pulmonary complications. Endotracheal suction is important to reduce the risk of lung consolidation and atelectasis. But for patients with respiratory insufficiency such as SCI, ordinary suction is not enough to clear secretions in the deeper airways. And repeated intratracheal suction may even cause some serious complications. Bronchoscopy can generally penetrate into the bronchus of grade 3-4, and fully attract the secretions in it under visual conditions. Its curative effect on pneumonia and atelectasis in the ICU has been affirmed, but no one has yet explored the application in the postoperative care unit .
The loss of the ability to walk and the associated restriction of mobility presents a major challenge to people with spinal cord injury in an everyday environment designed for pedestrians. Exoskeletal technology has the potential to help people with impaired leg function to regain ambulation and thus improve their independence. This technology is not completely new, but due to their high access price (~120k€/unit), high size and weight (~25 kg), and need for trained physiotherapist supervision, commercially available exoskeletons are only found in large hospitals and only in very few cases get into patients' homes. The company ABLE Human Motion S.L. (Barcelona, Spain) has developed a novel exoskeleton to overcome these disadvantages, which is more compact, lighter (9 kg) and easier to use. The primary objective of the study is to investigate the safety, feasibility and usability of the ABLE exoskeleton device in people with spinal cord injury during a four to six weeks gait training in clinical settings. Furthermore, potential effects of the training on walking, general health status, user satisfaction, and quality of life will be assessed.