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Spinal Cord Injuries clinical trials

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NCT ID: NCT05424172 Recruiting - Clinical trials for Spinal Cord Injuries

Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching

Start date: November 2, 2022
Phase: N/A
Study type: Interventional

The goal of this research is to increase physical activity among individuals with a spinal cord injury (SCI) through a customized, interactive smartphone-based health app and e-coaching using three phases: (1) leading focus groups of potential app users and clinicians to gain information regarding health apps preferences for optimal consumer use, (2) conducting a usability study of the customized app to determine the quality and implement further changes for optimization, and (3) conducting a sequential multiple assignment randomized trial (SMART) to determine the most effective adaptive intervention to improve exercise adherence. A SMART trial will be used to determine when and how to adapt dosage, timing, and delivery to increase adherence and address low-response behaviors. In Stage-I, the investigators will compare outcomes among participants using a generic, non-interactive exercise app (Group 1) to a customized, interactive app that can gain information through frequent Ecological Momentary Assessments (EMA) that will be used to modify each participant's exercise programs (Group 2). After 12 weeks, participants who are not meeting the exercise guidelines at least 50% of the time will also be asked to participate in motivational interviewing-based e-coaching either two or four times per month in addition to their originally assigned intervention (Stage-II). By completing these three phases, this project addresses deficiencies in exercise levels and compliance by implementing an individualized exercise prescription, an adaptive intervention for low responders, a way to address barriers to exercise, and a free smartphone app for broad implementation.

NCT ID: NCT05401734 Recruiting - Clinical trials for SCI - Spinal Cord Injury

Robot Assisted Gait Training in Persons With a Spinal Cord Injury

Start date: February 1, 2012
Phase:
Study type: Observational [Patient Registry]

Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion. What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected. Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted. The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI.

NCT ID: NCT05391308 Recruiting - Clinical trials for Obstructive Sleep Apnea

Overnight Upper Airway Infiltration in Spinal Cord Injury

OUI-SCI
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Obstructive Sleep Apnea (OSA), a common disorder resulting from repetitive pharyngeal collapse during sleep, is multifactorial. Usually, OSA is considered primarily a problem of upper airway anatomy, with the craniofacial structure or neck fat decreasing the size of the pharyngeal airway lumen. Obesity, male sex and genetics are well established pathogenic factors. In the last decade rostral fluid displacement (fluid shift) to explain the pathogenesis of upper airway collapsibility has been increasingly studied. Individuals living with spinal cord injury are at increased risk for OSA, with a prevalence that is three- to fourfold higher than the general population. Individual with acute tetraplegia and undiagnosed or untreated OSA may participate less in rehabilitation due to sleepiness and fatigue and therefore be less engaged in activities that improve quality of life and maintain functioning over time. Intermittent hypoxia, sleep fragmentation and alterations of the autonomous nervous system induced by OSA are thought to delay or limit recovery and in the long term, increase cardio- and cerebrovascular morbi-mortality. Redolfi et al have shown that overnight change in leg fluid volume correlated strongly with the Apnea Hypopnea index (AHI) and the time spent sitting. In SCI patients two mechanisms may underline fluid shift importance in the pathogenesis of OSA: first, time spent sitting is obviously increased in patients with no walking abilities (prolonged sitting position in wheelchair). Secondly, motor deficit lead to the loss of skeletal muscle pumping activity which could promote leg fluid accumulation during the day. In our knowledge, no study has specifically assessed the impact of rostral fluid displacement on upper airway collapsibility among patients with spinal cord injury. Better comprehension of upper airway collapsibility determinants in patients with spinal cord injury is mandatory to identify new therapeutic targets (diuretics, contention…) especially since CPAP, the first line treatment for severe OSA, continue to pose adherence issues in SCI patients. In the future, phenotyping OSA patients, especially those with SCI, will improve personalized management. The main objective is to find if there is a correlation between the apnea-hypopnea index (AHI) and rostral fluid shift overnight, in non-obese spinal cord injured patients. The secondary aim is to find if there is a correlation between AHI and: - Neck circumference - Neck volume - Time spent sitting down

NCT ID: NCT05390853 Recruiting - Clinical trials for Spinal Cord Injury Cervical

Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients

Start date: May 24, 2023
Phase: N/A
Study type: Interventional

Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of the upper limbs, of the hands in particular, represents a priority rehabilitation target. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in addition to the traditional physiotherapy treatment for the functional recovery of the upper limb, in incomplete traumatic tetraplegic subjects in the sub-acute phase after SCI occurrence. Patients hospitalized at the Montecatone Rehabilitation Institute are randomly assigned to Active tDCS or Sham tDCS.

NCT ID: NCT05386537 Recruiting - Clinical trials for SCI - Spinal Cord Injury

Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI

Start date: April 1, 2021
Phase: Early Phase 1
Study type: Interventional

This randomized clinical trial (RCT) is evaluating the usefulness of combining MyoMo robotic orthosis with visual and haptic feedback in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with acute SCI.

NCT ID: NCT05380661 Recruiting - Clinical trials for Spinal Cord Injuries

Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

Start date: July 15, 2022
Phase: N/A
Study type: Interventional

This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).

NCT ID: NCT05360719 Recruiting - Spinal Cord Injury Clinical Trials

Integrated Tele-exercise for Individuals With Spinal Cord Injury

Start date: April 30, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to examine the efficacy of an integrated, participant-centered tele-health physical activity program for individuals with SCI on psychological and social factors through a parallel mixed-methods design approach. We will examine changes in psychological (self-efficacy, self-esteem, exercise outcome expectations, depression, positive affect and well-being, quality of life) and social factors (participation and satisfaction with social roles and activities, activity engagement) following participation in an 8-week integrated group tele-exercise health and wellness physical activity program, with retention assessed at 8-weeks following completion (16 weeks from baseline). We will also complete small group interviews with all participants to understand participant experiences of, response to, and recommendations before and following participation in group tele-exercise program. To date, there is extremely limited evidence for the efficacy of psychological and social well-being of remotely delivered community-based exercise to individuals with SCI. A pilot effectiveness trial of a tele-exercise health and wellness program will be conducted using a mixed methods design with a randomized waitlist control group. Quantitative and qualitative data collection is sequential in nature and other data are collected simultaneously. Individuals with SCI (living with injury 12 months or longer) will be recruited based on existing partnerships locally and nationally. To assess limited effectiveness, we aim to enroll 35 individuals with SCI. Recruitment of these participants will stem from the investigator's ongoing community partnership with local and national partners. The tele-exercise health & wellness program will consist of virtual group class, twice per week, intended to generate physical confidence and strength for individuals living with SCI. Each session will be co-led with by an individual living with SCI.

NCT ID: NCT05351827 Recruiting - Clinical trials for Spinal Cord Injuries

Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries

MIH and AD
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The prevalence of autonomic dysfunction and sleep disordered breathing (SDB) is increased in individuals with spinal cord injury (SCI). The loss of autonomic control results in autonomic dysreflexia (AD) and orthostatic hypotension (OH) which explains the increase in cardiovascular related mortality in these Veterans. There is no effective prophylaxis for autonomic dysfunction. The lack of prophylactic treatment for autonomic dysfunction, and no best clinical practices for SDB in SCI, are significant health concerns for Veterans with SCI. Therefore, the investigators will investigate the effectiveness of mild intermittent hypoxia (MIH) as a prophylactic for autonomic dysfunction in patients with SCI. The investigators propose that MIH targets several mechanisms associated with autonomic control and the co-morbidities associated with SDB. Specifically, exposure to MIH will promote restoration of homeostatic BP control, which would be beneficial to participation in daily activities and independence in those with SCI.

NCT ID: NCT05351333 Recruiting - Clinical trials for Spinal Cord Injuries

Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

Start date: August 3, 2022
Phase: N/A
Study type: Interventional

The use of the conditioning open-label placebo (COLP) paradigm will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The goal is to provide the same level of pain relief with a reduced opioid intake to diminish side effects as well as the risk of addiction associated with opioid treatment.

NCT ID: NCT05343130 Recruiting - Clinical trials for Cervical Spinal Cord Injury

Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The study's main goal is to determine the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.