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Spinal Cord Injuries clinical trials

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NCT ID: NCT05934968 Not yet recruiting - Depression Clinical Trials

Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes

Start date: September 2023
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) and multiple sclerosis (MS) are both conditions characterized by chronic inflammation as indicated by elevated levels of circulating pro-inflammatory cytokines. These cytokines can have a wide array of negative impacts such as increasing the risk of depression and the intensity and frequency of neuropathic pain. Recent work in the investigator's laboratory has shown that a 3-month anti-inflammatory diet is not only effective in reducing pro-inflammatory cytokines, but also in reducing depression and neuropathic pain, by approximately 55% and 40%, respectively. However, a one-year follow-up study from the investigator's lab showed such adherence to be very challenging and therefore, strategies are required to address barriers to healthy eating in those with neurological disability. Accordingly, the investigators have developed a modified anti-inflammatory diet (Mad Dog diet) that is more palatable, less expensive and less demanding, as well as a 2-part pre-diet consultation that effectively increased self-efficacy for dietary adherence, and actual adherence one month post-consult. Still, participant feedback suggests that further efforts are needed to help ensure long term adherence to anti-inflammatory diets for those with neurological disability. As such, the investigators have developed the 6-week Mad Dog cooking series. This series consists of a once-weekly cooking class and educational session where a group of individuals with neuromuscular disability can come together to learn about the health benefits of an anti-inflammatory diet, receive instruction on how to cook selected anti-inflammatory recipes, and experiment with various pieces of accessible kitchen equipment that may increase their meal preparation skills. The purpose of this study is to test the 6-week Mad Dog cooking series in individuals with neuromuscular disability to gauge consumer satisfaction and make preliminary measures on self-efficacy for adhering to the Mad Dog anti-inflammatory diet, as well as actual adherence 6 months after the series has been completed. The investigators will also determine if the series has any effect on depressive symptoms.

NCT ID: NCT05926843 Recruiting - Clinical trials for Spinal Cord Injuries

Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury

NeuroSCS
Start date: April 19, 2023
Phase: N/A
Study type: Interventional

Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with spinal cord injury (SCI). The investigators will enroll ten research participants with clinically incomplete/complete SCI (patients with paraplegia or severe paraparesis) who will undergo SCS subsequently assisted by motor rehabilitation training for restoring motor function at IRCCS Ospedale San Raffaele, Milan, Italy. The main goal of the project is to evaluate the improvement in motor function generated by the combination of SCS and locomotor training. In line with recently published studies, the investigators propose that daily locomotor training in the presence of SCS with continuous stimulation parameters setting will enable the SCI individuals to stand and step independently while bearing full weight.

NCT ID: NCT05926596 Not yet recruiting - Spinal Cord Injury Clinical Trials

Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function in people with movement disorders. The study investigates the effects of wearing the device during a set of experiments including leg stretching, treadmill walking and overground walking in muscle activity, joint motion, and gait performance. The goal is to develop an effective lower-limb strategy to restore lost leg function (e.g., range of motion) and gait ability, and improve quality of life in people with movement deficits following a neurological disorder.

NCT ID: NCT05926310 Recruiting - Clinical trials for Spinal Cord Injuries

Safety and Feasibility of TWIICE Rise

Start date: July 25, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury. This study is done in two phases: The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with 5 patients over 6 sessions in clinic. The second phase is being conducted with TWIICE Rise 1.0. This version has potentially improved functionalities based on feedback from Phase 1. Safety and feasibility will be assessed with 10 patients over 24 sessions in different settings (clinic, home, and community environment).

NCT ID: NCT05921487 Enrolling by invitation - Obesity Clinical Trials

Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) causes paralysis and muscle atrophy and leads to weight gain and obesity. Obesity directly contributes to functional impairment and cardiometabolic dysfunction. There is a critical need to reduce the growing prevalence of obesity and cardiometabolic disease after SCI. My overall objective in this project is to gather crucial feasibility data on time restricted eating (TRE), a novel form of intermittent fasting. TRE is a straightforward method to induce weight loss without the need for calorie counting. TRE allows individuals to eat all their daily calories in a time restricted window and fast outside that window. A growing body of literature supports the safety and efficacy of TRE. Given the feasibility, high adherence, and substantial benefits of TRE in able-bodied individuals, it is important to test TRE to determine its feasibility in Veterans with SCI. The investigators will first test this intervention in Veterans with thoracic paraplegia, who are at greatest risk of muscle-joint upper body injury given the need to support body weight during activity. The investigators will determine adherence to a TRE window for 6-weeks duration in a convenience sample of Veterans with thoracic paraplegia and obesity. Based on the expected outcomes of good adherence, this study will lay the groundwork for future work by informing the design of a randomized controlled trial to test the efficacy of TRE to facilitate weight loss and improve function.

NCT ID: NCT05921175 Not yet recruiting - Spinal Cord Injury Clinical Trials

tSCS + EksoGT in SCI Patients

Start date: October 2023
Phase: N/A
Study type: Interventional

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic paraplegia. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord paraplegia. 6 subjects will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.

NCT ID: NCT05919563 Active, not recruiting - Clinical trials for Spinal Cord Injuries

LTFU Study of Subjects Who Received GRNOPC1

Start date: October 6, 2011
Phase:
Study type: Observational

This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.

NCT ID: NCT05908175 Enrolling by invitation - Clinical trials for Spinal Cord Injuries

FES-assisted Gait Intervention in People With Spinal Cord Injury - Pilot Study

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities such as walking. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Locomotor training with FES may be a promising method to improve gait function. The primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. Secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

NCT ID: NCT05906056 Recruiting - Stroke Clinical Trials

Continuous Passive Motion Versus Heterotopic Ossification

CPMversusHO
Start date: May 12, 2023
Phase: N/A
Study type: Interventional

The investigators hypothesize that Heterotopic Ossification (HO) formation can be suppressed if the application of a Continuous Passive Motion (CPM) device can be performed for a substantial amount of time. The investigators will use the following study design: a pilot study with 10 ICU patients receiving CPM and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. The comparison between the treatment and referent groups of the outcomes will prove the prophylactic power of CPM against HO.

NCT ID: NCT05904600 Recruiting - Clinical trials for Spinal Cord Injuries

Respiratory Muscle Training in Adults With Spinal Cord Injury

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

The purpose of this study is to investigate the effectiveness of a programme based on inspiratory and expiratory muscle training to improve respiratory muscle strength, functional capacity and avoid pulmonary complications in adults with cervical or high dorsal spinal cord injury (C5-D5) in acute phase.