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NCT06882460
The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.
NCT06003686
The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.
NCT06596369
Transcutaneous electrical stimulation (tcES) of the spinal cord has shown great promise in restoring upper extremity function after spinal cord injury (SCI). More recently, the use of invasive, epidural electrical stimulation of the spinal cord has also demonstrated promise in restoring upper extremity function post-stroke. However, the effect of stimulation parameters such as electrode configuration and stimulation frequency on excitability of the nervous system remains unknown preventing the opportunity to fully exploit this noninvasive stimulation paradigm. Additionally, the utility of noninvasive tcES in the stroke population remains unexplored. This project utilizes a comprehensive set of neurophysiological techniques, in combination with carefully chosen motor tasks, to directly link and assess the effects of stimulation parameters on neural excitability and upper extremity function during and following the delivery of cervical tcES in individuals with SCI and stroke. The fundamental knowledge gained from this project will ultimately improve the implementation of this novel and non-invasive neuromodulatory tool through an improved understanding of how tcES can facilitate recovery of function.
NCT04668326
People with spinal cord injuries (SCI) are particularly prone to complications from excessive sitting, because many are not able to stand without support. Excessive sitting after SCI is believed to contribute to pressure injuries, pain, osteoporosis, joint stiffness, spasticity, and worsening bowel and bladder function. The VA has developed, patented, and licensed a mobile manual standing wheelchair (MMSW), and the investigators believe the key feature of being able to wheel around while in a standing position will dramatically change how paralyzed Veterans function in their home and community. If this expanded utility is realized, persons with SCI may naturally spend more time standing and less time sitting. To test these ideas, Veterans with SCI will be randomized to using one of two manual standing wheelchairs at home and in the community for two months.
NCT05432999
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Common symptoms include spasms and stiffness, and can occur more than once per hour in many people with SCI. Spasticity can have a negative impact over many quality of life domains, including loss of functional independence, activity limitations, and even employment. Its impact on health domains is also pronounced, with many people who have spasticity reporting mood disorders, depression, pain, sleep disturbances, and contractures. Spasticity can interfere with post-injury rehabilitation and lead to hospitalization. There are many treatments for spasticity in this population. However, many do not have long-term efficacy, and, if they do, they are often pharmacological in nature and carry side effects that could limit function or affect health. The goal of this pilot, randomized-controlled study is to investigate the potential efficacy and safety of a non-invasive treatment with a low side effect profile, extracorporeal shockwave therapy (ESWT). ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects. Thirty individuals with chronic, traumatic SCI will be recruited. Fifteen will be provided with ESWT while the other fifteen will be given a sham treatment. Clinical and self-report measures of spasticity and its impact on quality of life will be collected, as well as quantitative ultrasound measures of muscle architecture and stiffness. The ultimate goal of this pilot project is to collect the data necessary to apply for a larger randomized-controlled trial. Conducting a larger trial will allow for a more powerful estimation of safety and efficacy of ESWT as a treatment for spasticity in people with SCI.
NCT05563103
The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury.
NCT04881565
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.
NCT06521723
The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury of different age groups.
NCT05777941
The new training device, the eccentric arm-crank, will be examined for its training effects in athletes with a spinal cord injury (SCI) by this project. That the training device can be used in patients with paraplegia in the future, the so-called "testing of the applicability of this concept" will be carried out during this study. Fourteen volunteer, healthy athletes with SCI are first tested for their upper body performance, followed by a training phase over 20 trainings and at the end the performance data is collected again. The training intensity and duration is continuously increased during the training phase.
NCT07386522
The goal of this pilot study is to design and feasibility test a mobile phone text messaging (SMS) self-management intervention for persons with spinal cord injury (PwSCI). The project will focus on providing a 16-week text messaging intervention on the secondary health conditions of bowel/bladder management, pain, pressure injury, and psychosocial health. Our hopes are to reduce the impact of secondary health conditions (SHC) for PwSCI. The project hopes to test whether the developed self-management program will be feasible and superior to a control group. determine the feasibility and efficacy of the SMS intervention main questions the study aims to answer are: Participants will: Complete an initial assessment Participate in a 16-week text messaging program using their mobile phones Complete 4-week check-ins Complete a post assessment The main question\[s\] it aims to answer \[is/are\]: \[primary hypothesis or outcome measure 1\]? \[primary hypothesis or outcome measure 2\]? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
NCT06726954
The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with spinal cord injury.
NCT05645003
The aim of our study is to investigate the effect of high-frequency Repetitive Transcranial Magnetic Stimulation(rTMS) therapy applied to the dorsolateral PFC (DLPFC) area on neuropathic pain in patients with spinal cord injury. In this area, there are very few studies on the effectiveness of rTMS treatment added to medical treatment in neuropathic pain. In addition, the number of studies comparing the effect of rTMS therapy applied to the DLFPC area is very few.
NCT07210411
The purpose of this research is to learn about how the participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.
NCT06514950
The goal of this interventional study is to understand how regular yogic breathing practice, particularly a slow resistive yogic breathing technique called Ujjayi, would benefit individuals between the ages of 18 and 60 with spinal cord injuries. Previously yogic breathing has shown to improve respiratory function and sleep- we'd like to explore this further. The main questions this study aims to answer are: * How does Ujjayi breathing affect breathing patterns in individuals with spinal cord injuries? * How does Ujjayi breathing affect lung function in individuals with spinal cord injuries? * How does Ujjayi breathing affect the part of the nervous system responsible for ventilatory control in individuals with spinal cord injuries? * How does Ujjayi breathing affect ventilatory perfusion (how well air and blood flow match in the lungs for efficient gas exchange) in individuals with spinal cord injuries? * How does Ujjayi breathing affect sleep quality in individuals with spinal cord injuries? Participants will undergo six weeks of training in Ujjayi breathing. Before and after this period, they will visit the lab for measurements of blood pressure, pulse, blood oxygen levels, and breathing. They will also perform several tests: * Pulmonary function testing to assess lung capacity and respiratory muscle strength. * Pace breathing frequency to four pre-recorded audio files at various breathing rates. * Breathing exercises involving higher levels of carbon dioxide for a short time. * Breathing exercises involving lower levels of oxygen for a short time. * At-home sleep evaluation. Between the two laboratory testing sessions, participants will practice yogic resistance breathing (Ujjayi breathing) for six weeks.
NCT04748835
People with SCI are at higher risk of obesity and chronic diseases, such as hypertension, high cholesterol, diabetes and cardiovascular disease, than the general population. Researchers currently lack data on factors that influence weight gain among people with SCI. During this one-year observational study, study staff will enroll 60 individuals with SCI while they are inpatients at Baylor Scott \& White Institute for Rehabilitation (BSWIR). Data will be collected at 3 time periods (before discharge and 6 and 12 months after discharge) in order to better understand factors that affect weight gain over the first 12 months following discharge from inpatient rehabilitation, such as nutritional intake, environmental access, psychosocial factors, energy requirements and risk factors for metabolic syndrome. These data will be used to inform future interventions for people with SCI.
NCT04288245
Texas Biomedical Device Center at UT Dallas has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, an early feasibility study and an independent, double-blind, placebo-controlled study in chronic stroke participants indicate that VNS is safe in participants with upper limb deficits, and yields a clinically-significant three-fold increase in neural connections during rehabilitation exercises. Given the track record of safety and potential for VNS to enhance recovery of upper limb motor function in spinal cord injured individuals, the purpose of this double blind randomized placebo controlled optional open-label extension study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with SCI. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial. Participants may undergo additional sessions of training with VNS.
NCT06242873
Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions. Aim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation. Aim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies.
NCT06003712
The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI
NCT07440459
The goal of this observational study is to assess the course of motor and functional gait recovery induced by Lokomat robot-assisted gait rehabilitation in patients with spinal cord injury. The main question it aims to answer is: How does gait motor and functional multilevel recovery progress over time in patients with spinal cord injury? Assessmets will be conducted at four time points: pre-intervention, mid-intervention, post-intervention, and at 1-month follow-up after the completion of robot-assisted gait rehabilitation. Data will be collected at multiple levels, including: * Clinical tests * Three-dimensional gait analysis with kinematic, kinetic, and electromyographic measurements * Maximum isometric strength * Nerve conduction parameters
NCT07153536
This study plans to use systems that have been developed by Medtronic to investigate the use of cervical spinal cord stimulation to treat adults with upper limb hemiparesis resulting from a stroke. The spinal cord stimulation (SCS) will be combined with physical training to improve arm and hand motor control. The study is divided into three phases. In the first phase, after baseline assessments, participants will undergo a Physical Training Protocol (PTP) for 6 weeks including 3 sessions of 90 mins/session per week. After receiving the Medtronic implantable system, in Phase 2, they will then repeat the same PTP program in combination with spinal cord stimulation during the entirety of each of the rehabilitation sessions. Finally, in Phase 3, participants will go home, will not be able to use the stimulation at home but will participate in monthly assessments in the laboratory in which the functionality of the Medtronic system and their motor performances will be assessed for up to 6 months.