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NCT07669181
Background and Rationale: Traumatic spinal cord injury (SCI) affects approximately 12,400 individuals annually in the USA, predominantly impacting healthy young adults aged 20-40 years. Complete SCI above the lumbar region results in paraplegia or tetraplegia, severely compromising quality of life. Wheelchair-dependent lifestyle and immobilization lead to serious secondary complications including osteoporosis, diabetes mellitus, atherosclerosis, pressure ulcers, depression, and pathological fractures. Robotic exoskeletons have emerged as promising rehabilitation tools since the 2000s, enabling independent walking and stair climbing beyond wheelchair use. Study Objectives: This clinical trial investigates the role of ReWalk lower-limb human exoskeleton in rehabilitation by: Integrating exoskeleton-assisted gait training into rehabilitation protocols and comparing functional and physiological outcomes with conventional conservative treatment in SCI-induced paralysis Examining gastrointestinal and urogenital changes Assessing general well-being and patient compliance Methods: This prospective, controlled study enrolls patients with lower limb paralysis following SCI for minimum 6-month rehabilitation. The control group receives traditional physiotherapy and physical rehabilitation only. All procedures comply with Good Clinical Practice principles and applicable regulations. Inclusion criteria (FDA-approved): Complete SCI below T4 with paraparesis/paraplegia; ≥4 months post-injury; adequate arm/shoulder strength for crutch use; appropriate bone density (hip t-score \>-3.5); intact skeletal system with stable spine; ability to stand safely; good general health; height 160-190cm; weight ≤100kg; adequate lower limb range of motion. Exclusion criteria: Severe neurological diseases beyond SCI; significant concurrent illnesses; severe spasticity (Modified Ashworth 4); unstable spine or limbs; heterotopic ossification; significant contractures; psychiatric/cognitive impairment; pregnancy. Training Protocol: The rehabilitation program consists of five phases: Paravertebral and back muscle strengthening (weeks 1-4): Core strengthening exercises focusing on sitting balance, assessed weekly via trunk control measurement scale Standing, sitting, and device donning (weeks 5-6): Learning independent device application and safe standing balance Gait training (weeks 7-8): Mastering independent device control through various stepping patterns Stair training (weeks 9+): Learning stair negotiation after passing final skill test Follow-up phase (6+ months): Maintenance therapy at reduced frequency (3x/week) Assessment Parameters: Baseline assessments include: ASIA Impairment Scale, bone densitometry, Modified Ashworth Scale, Barthel Index, Functional Independence Measure (FIM), VAS pain/fatigue scales, SF-36, Beck's anxiety/depression inventories. Progress evaluations at major milestones include functional tests (10-meter walk, Timed Up-and-Go, Berg Balance, Spinal Cord Independence Measure) and ReWalk skill assessments. Follow-up assessments (6-month minimum) repeat baseline measures focusing on bone density, functional independence, quality of life, and mental health. Expected Outcomes: Improved bone density with exoskeleton training compared to conventional treatment Improved general well-being and better patient compliance This study aims to confirm previous international findings demonstrating superior outcomes with robotic rehabilitation technology regarding spasticity reduction, bone density preservation, body composition improvement, and gastrointestinal/urogenital/mental health enhancement compared to traditional treatment approaches.
NCT07663266
Just-In-Time Adaptive Interventions (JITAIs) offer a framework for delivering personalized behavioral support using time-varying data to optimize the timing and type of intervention content. This project will develop the foundational components of a JITAI tailored to adults with chronic pain and either MS or SCI by drawing on symptom self-management content from existing programs (PainGuide, MyMSToolkit, and MySCIToolkit). Intervention content and delivery parameters will be refined through stakeholder engagement via structured interviews to ensure relevance, acceptability, and feasibility.
NCT07645144
Spinal cord injuries (SCI) impair neural communication, leading to difficulties in walking due to muscle weakness, altered reflexes, and impaired muscle activation below the injury. Functional electrical stimulation (FES) has been shown to enhance voluntary control, strength, and walking performance when used during gait training. This study aims to assess whether the FES yields superior improvements in walking ability compared to conventional gait training without stimulation.
NCT07641101
This is a single-blind randomized controlled trial for patients with neurogenic bladder after incomplete spinal cord injury. Participants are randomly divided into two groups. The control group receives routine transitional nursing and telephone follow-up, while the intervention group gets 4-week app-supported transitional care including health education, bladder recording and online consultation. After intervention, bladder residual urine, urinary tract infection rate, self-care ability and quality of life are compared between two groups.
NCT07090473
The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement. The main questions it aims to answer are: * is starting electrical stimulation 3 days post SCI safe? * can starting electrical stimulation 3 days post SCI help patients recover movement? This study will be done in two phases. Both phases will be done during the patient's stay in the hospital/intensive care unit (ICU). In the first phase, participants' will undergo several tests before and after a single treatment. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs and feel touch or pin prick * blood and cerebral spinal fluid draws * assessment of their spinal cord function using electrical stimulation * receive a single 60-minute continuous electrical stimulation treatment * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings. In the second phase, researchers will compare active electrical stimulation to sham stimulation to see if active stimulation safely leads to improvement in person's movement ability. In this second phase, participants' will undergo tests before and after electrical stimulation treatment which will be delivered 5 days in the row. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs (every day) and feel touch or pin prick (before and after 5 days of treatment) * blood and cerebral spinal fluid draws (before the first treatment session and before going home) * assessment of their spinal cord function using electrical stimulation (before the first treatment session and before going home) * receive daily 60-minute continuous electrical stimulation treatment for 5 days while in ICU * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.
NCT07380516
After spinal cord injury (SCI), many people lose their ability to walk and do not have access to equipment and assistance that could help them regain functional abilities. Furthermore, many who have the potential to regain function are further hindered by a loss of function in their upper body that limits their ability to use a walker or crutches, thus eliminating options for mobility. This study seeks to determine the safety and feasibility of the XoMotion-R, a self-balancing exoskeleton that allows people with American Spinal Injury Association Impairment Scale (AIS) rating of B-D SCI to walk hands-free in inpatient and outpatient settings. This study will examine how use of the XoMotion-R affects functional outcomes and identify setting-specific barriers and facilitators to clinical adoption. This single-arm feasibility study will recruit 8 SCI inpatients and 8 SCI outpatients whose goal is to improve their walking and incorporate the XoMotion-R into their rehabilitation sessions. Participants will work on a variety of gait tasks tailored to their functional level. The goal is to determine whether early robotic gait training can improve functional outcomes and decrease length of stay, secondary complications, and long-term disability burden.
NCT07213986
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
NCT06463418
The goal of this feasibility trial is to learn if exoskeleton or robotic walking works to reduce nerve (neuropathic) pain after spinal cord injury. This study asks is: * Providing walking practice through use of a robotic device (exoskeleton) three times per week for twelve weeks possible to deliver? * Would people sign up and stick to the programme? * And will it help to reduce neuropathic pain levels after spinal injury? Researchers will compare robotic walking and a relaxation program to see if robotic walking works to reduce neuropathic pain levels after spinal injury. Participants will: * Complete a number of questionnaires and tests related to their pain before the trial. * Complete robotic walking or a relaxation program three times per week for twelve weeks. * Complete the same questionnaires and tests after the trial finishes and 6 months after. * Complete an interview telling researchers about their experiences of the trial.
NCT07457645
This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening/baseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.
NCT04241250
Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent standing and stepping. These current methods require 3-4 highly skilled therapists and may not be feasible in all rehabilitation settings, especially when considering the growing number of SCI patients each year. Therefore, the use of robotic exoskeleton suits combined with direct stimulation of the spinal cord (requiring 1-2 therapists) may offer an alternative rehabilitation approach to overcome their limited abilities to stand and walk. Such improvements may also help to reverse or eliminate other health-related consequences associated with SCI. The pilot work will provide the preliminary evidence required to design future clinical trials for Veterans and civilians with SCI to restore overground mobility.
NCT07550699
The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair gait, including spinal cord injury, acquired brain injury, and multiple sclerosis. The secondary objective is to collect preliminary data on the potential clinical and psychosocial benefits of combining robotic gait assistance with electrical stimulation.
NCT07212725
Brief Summary The goal of this clinical trial is to evaluate whether a neuroscience-informed, peer-led self-management program can promote behavior change and reduce pain interference in adults with spinal cord injury (SCI) and chronic pain. The primary aim is to support participants in developing practical, sustainable strategies for managing chronic pain through education, reflection, and consistent application of self-management tools. The program is designed to shift participants from passive recipients of care to active agents in their own pain management process. Chronic pain is highly prevalent among individuals with SCI, and many report that traditional treatments - primarily pharmacological - provide limited relief and are accompanied by significant side effects. There is a growing need for accessible, non-clinical interventions that empower individuals to manage pain based on the latest neuroscience and behavior change principles. Solving SCI Pain intervention is a 7-week, multi-component program grounded in brain-based pain science, neuroplasticity, and behavior change models. The main questions it aims to answer are: * Does the intervention lead to meaningful changes in behavior that support pain self-management? * Does it reduce pain interference in everyday life? Participants will: * Attend three 2-hour group education sessions focused on the neuroscience of pain, the role of fear-avoidance, pain-related beliefs, and body-based self-regulation tools (e.g., movement, Graston, percussion massage, and red light therapy). * Participate in four individual coaching sessions (up to 1 hour each) designed to help them reflect on their experiences, overcome barriers, and integrate the tools into daily life. * Follow individualized coaching recommendations and provided resources to support each participant's unique engagement with cognitive and body-based tools over the 7-week period, including light journaling, goal setting, and guided reflections. * Complete brief check-ins every four days to monitor progress, engagement, and self-reported outcomes. Group and coaching sessions will be recorded and transcribed to support qualitative analysis, allowing researchers to understand how the intervention is experienced and delivered. This will help refine the program for future implementation and scaling. The study prioritizes accessibility, relevance, and peer involvement to address the real-world needs of individuals living with SCI and chronic pain.
NCT07234903
The EIGER study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support and promote recovery of ambulatory functions, such as walking, in people with subacute and chronic spinal cord injury.
NCT05403606
The investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these variables of seat (bad positioning, prolonged supports etc...) This study will be carried out over a long period of time (1 year), in an ergonomic situation of integration in the daily life of the participants. The main objective of this randomized controlled study is to study the difference in the incidence of pressure sores according to the use or not of this device. A qualitative study of the experience and perceived benefit of its use and a medico-economic study are associated to judge the expected interest in making this type of embedded device more systematically integrated into the classic movement equipment (wheelchair and seat cushion) of people with a spinal cord injury
NCT07473258
The goal of this clinical trial is to learn if a 10-week web-based health promotion program ("DRIV") can improve healthy lifestyle habits and overall well-being in adults living with long-term spinal cord injury (SCI). The main questions it aims to answer are: Does participating in the online course lead to healthier lifestyle behaviors (for example, more physical activity and a better diet) and improved self-reported health for people with SCI? Are any improvements in health habits or well-being maintained six months after completing the program? Researchers will compare participants who take the 10-week DRIV course to those on a waitlist (no intervention during that period) to see if any changes in lifestyle or health outcomes are due to the program (and not just time or other factors). Participants will: Attend a 1-hour group session online (via video) each week for 10 weeks, covering topics like exercise, nutrition, stress management, and goal setting (this is the intervention for the course group; waitlist group has no sessions during this time). Complete health questionnaires at the start of the study and after 10 weeks (all participants), and again 6 months after the course for those who received the intervention, to report on their lifestyle habits, physical and mental health, and goal achievement. Wear a wrist activity monitor (accelerometer) for 7 days at the beginning and 7 days at the end of the 10-week period to objectively measure physical activity levels.
NCT07524491
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic cardiovascular regulation during exercise and recovery in individuals with chronic spinal cord injury (SCI). Participants undergo two experimental conditions (active taVNS and sham stimulation) in a randomized crossover design while performing a standardized exercise protocol. Heart rate variability (HRV) is used as a non-invasive biomarker to assess autonomic nervous system dynamics across different phases (baseline, exercise, and recovery). The aim is to characterize physiological responses to neuromodulation and explore whether taVNS modulates autonomic adaptability in this population. This is a mechanistic physiological study designed to improve the understanding of autonomic regulation in SCI and to explore potential biomarkers of response to neuromodulation.
NCT07507331
This observational study aims to evaluate the cross-cultural adaptation and psychometric properties of the Turkish version of the Neurogenic Bladder Symptom Score Short Form (NBSS-SF) in adults with spinal cord injury or multiple sclerosis who have neurogenic lower urinary tract dysfunction. Neurogenic bladder symptoms, such as urinary incontinence, urgency, and difficulties with urine storage or emptying, may negatively affect daily functioning and quality of life. In this study, the validity and reliability of the Turkish NBSS-SF will be examined, and convergent validity will be assessed through its relationship with the King's Health Questionnaire (KHQ) and the Short Form-12 (SF-12). In eligible participants, the scale will be administered again after 7 to 14 days. The aim of the study is to provide a valid and reliable Turkish patient-reported outcome measure for use in clinical practice and research.
NCT06850363
This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for individuals with traumatic spinal cord injury. The study consists of a baseline evaluation and 1-week training period (Week 0), a 4-week stimulation period (Weeks 1-4), and a follow-up visit (Week 5), for a total expected duration of participation for each subject of six weeks.
NCT07429305
The goal of this clinical trial is to understand how sensory inputs from the lower leg can influence pelvic floor muscle function and urogential function in adults with chronic spinal cord injury (SCI). The main questions it aims to answer are: 1. What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI? 2. What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI? 3. What are the potential effects of combined tibial neuromodulation and standing therapy on reflex excitability and urogential symptoms and quality of life in people with SCI? Participants will be asked complete a series of assessments (questionnaires, electrophysiological testing) before and after a 12-week intervention of combined standing and tibial nerve stimulation therapy.
NCT07511244
This clinical trial aims to evaluate the safety and efficacy of spinal cord stimulation (SCS) in treating patients with urinary and bowel dysfunction after spinal cord injury (SCI). SCI is a highly disabling condition that can lead to sensory, motor, and autonomic nervous system dysfunction below the injury level. Neurogenic bladder and bowel dysfunction are common sequelae of SCI, seriously affecting patients' quality of life. Currently, clinical treatments can only partially alleviate urinary and bowel dysfunction, and more effective therapeutic approaches are still needed. Existing clinical studies have shown that SCS is gradually being applied to treat neurogenic bladder and bowel dysfunction in SCI patients. SCS can significantly improve urinary efficiency, bladder capacity, compliance, and detrusor pressure in SCI patients, thereby enhancing their quality of life. The main questions this study aims to answer include: 1. Can this protocol help patients restore partial urinary and bowel function? 2. Besides the restoration of partial urinary and bowel function , can the SCS therapy could also help patients to restore the walking function. Patients with urinary and bowel dysfunction more than 6 months after spinal cord injury will undergo epidural spinal stimulation electrode implantation surgery two weeks after functional assessment. Then the parameter optimization and rehabilitation will last for 6 months. The follow-up records and assessments will be conducted monthly at 2, 4, and 6 months after surgery.