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Spinal Cord Injuries clinical trials

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NCT ID: NCT03962218 Completed - Clinical trials for Spinal Cord Injuries

Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries

FALMI
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Purpose of the study: To analyse the effectiveness of aquatic physiotherapy on spinal cord injuries (LMi) in the improvement of balance and gait, in the inflammatory profile, and the impact on the quality of life. Main objective: To analyse if there are differences in the recovery of the balance, in incomplete subacute spinal cord injuries, with lesion level T1-L5 and ASIA (American Spinal Injury Association) C and D . Secondary objectives: 1. functional gait 2. To evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait. 3. To study the effect of aquatic therapy on serum markers of systemic inflammation. 4. Quality of life related to health. Design: Crossed, controlled and randomized clinical trial, with blind evaluation of the response variables. Scope of the study: National Hospital of Paraplegics. Toledo (Spain). Population: Subjects with incomplete spinal cord injury ASIA C and D. n = 50 (25 in each arm randomly). Intervention: 6 weeks of specific Aquatic Physiotherapy (3 times a week). Group 1 will perform aquatic physiotherapy at the time of entering the study, and group 2 will perform it 6 weeks later. Outcomes: Static and dynamic balance (Berg test and Time Up and Go). Speed of the gait (test of 10 m.). Gait resistance (6 min. Test). Functional capacity of the gait (WISCI II). Biomechanical analysis (sensorial-dynamic, rhythmic and directional control, and gait test) by posturography. Questionnaires EuroQol-5Dimensions-5Level (EQ-5D-5L) and the Spanish Version of the Quality of Life Index (SV-QLI) in spinal cord injury (SCI). Biomarkers of inflammation: 20 cytokines. Analysis of results: The main outcome measure will be the percentage of patients who have improved. Considering improvement when the difference between the groups is, at least, a 10% of their score in the Berg test between V0 and V1 (with their corresponding 95% confidence intervals). It will be adjusted for confounding and interaction factors with a multivariate analysis using logistic regression. All analyses will be performed according to the intention to treat principle.

NCT ID: NCT03955523 Completed - Clinical trials for Spinal Cord Injuries

Single Exercise Session or Meal vs Control in SCI: Case Series

Start date: January 6, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the immediate effects of a single exercise session or a high fat/high carbohydrate meal on the physical and mental health of people with a spinal cord injury (SCI). Specifically, we want to better understand the responses in people with SCI when they conduct exercise or eat an unhealthy meal, when looking at inflammation levels, the number and function of immune cells, brain function, pain and how one feels (affect). If we can understand these responses, then clinicians, sports practitioners and dieticians can provide better advice to people with SCI.

NCT ID: NCT03949699 Completed - Clinical trials for Spinal Cord Injuries

Resistance Training to Improve Strength and Functional Trunk Stability in Adults With Paraplegia

Start date: November 24, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effectiveness of an 8- week resistance training routine to improve functional trunk strength, muscle activation, and physical functioning in exercise in 30 adults with paraplegic SCI. This study will also examine outcomes of confidence in one's ability to avoid falling during balance challenges, and self-efficacy for participating in exercise activity.

NCT ID: NCT03945110 Completed - Clinical trials for Spinal Cord Injuries

Intravesical Glycosaminoglycan Instillation and Urinary Tract Infection in Acute Spinal Cord Injury

Start date: September 18, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and feasibility of administering glycosaminoglycan (GAG) therapy, iAluRil®, intravesically in individuals with acute spinal cord injury (SCI), commencing within the first ten days of injury, to prevent early urinary tract infections.

NCT ID: NCT03941600 Completed - Clinical trials for Spinal Cord Injuries

Feasibility of Exercise and Spinal Cord Injury

Start date: April 10, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to examine the impact of a community-based exercise intervention (CBEI) for persons with spinal cord injury (PwSCI) on physiological and psychological well-being and identify barriers and facilitators to implementation.

NCT ID: NCT03940274 Completed - Spinal Cord Injury Clinical Trials

Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) is the common leading cause of death among people with spinal cord injury (SCI) and occurs at an early age in people with SCI as compared to able-bodied people. The findings are consistent in demonstrating a high prevalence of CVD among people with SCI. Lack of physical activity and/or prolonged sitting which is observed in people with SCI due to impaired/loss of motor function is associated with increased risk factors of CVD. By doing this study, researchers hope to learn the effects of walking training on cardiovascular health among people with chronic SCI.

NCT ID: NCT03935321 Completed - Clinical trials for Spinal Cord Injury, Acute

NISCI - Nogo Inhibition in Spinal Cord Injury

NISCI
Start date: May 15, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the NISCI trial is to test if an antibody therapy can improve movement and quality of life of tetraplegic patients. A previous trial showed this treatment is safe and well accepted. This is a placebo controlled, randomized, double blind, multicenter, multinational study to assess the safety, tolerability, feasibility and preliminary efficacy of early (within 4-28 days post injury) initiation of treatment with repeated bolus injections of NG-101 in cervical acute SCI patients. The study has 3 phases: screening/baseline Phase, treatment phase, and a follow-up phase. The study design will allow simultaneous enrolment of patients with complete or incomplete SCI. Enrolment and stratification of the patients is based and individualized prediction of upper limb outcomes. For further information please visit NISCI website: https://nisci-2020.eu

NCT ID: NCT03914456 Completed - Clinical trials for Injuries, Spinal Cord

Assessment of Neurorehabilitation in Spinal Cord Injury Using Neuroimage Tools.

Start date: February 2, 2007
Phase: N/A
Study type: Interventional

The sensorimotor cortex may play a role in the functional recovery after Spinal Cord Injury (SCI) through efference generated in the absence of the afference. OBJECTIVE: The purpose of this study was to evaluate the potential reorganization in the sensorimotor cortex in SCI patients after Body Weight Supported Treadmill Training (BWSTT) associated with conventional motor rehabilitation. METHOD: Seven SCI patients with ASIA C and D participated in this study. They were submitted to a motor-task functional magnetic resonance imaging study (fMRI) before and after the rehabilitation treatment.

NCT ID: NCT03908047 Completed - Clinical trials for Spinal Cord Injuries

Functional Changes in the Brain After Tibial Nerve Stimulation: a Pilot Study

Start date: July 15, 2019
Phase:
Study type: Observational

The lower urinary tract is innervated by the autonomous (sympathetic, parasympathetic) and the somatic nervous system. Afferent information from the lower urinary tract (LUT) (e.g. filling state and volume of the urinary bladder) is conducted via the dorsal roots to the sacral spinal cord and from there to the pontine micturition center (PMC) in the brain stem. The PMC has several connections to other cortical areas. These complex interactions with the cortex enable voluntary control of the LUT and are crucial for urinary continence. The integrity of this neuronal circuit is crucial for an undisturbed function. Deterioration of the nerve fibers due to a systemic neurological disease (e.g. spinal cord injury) can affect LUT function. Neurogenic lower urinary tract dysfunction can lead to urgency, urge incontinence, reduced bladder capacity and secondary deterioration of the upper urinary tract (i.e. kidneys). First-line therapy of neurogenic detrusor overactivity contains antimuscarinic treatment. In case of side effects or remaining detrusor overactivity, nerve stimulation (e.g. sacral neuromodulation and in effect nerve tibialis stimulation) is an accepted therapy option. The precise mechanism of action of these neuro-modulatory procedures is still unknown. Utilizing state-of-the-art neuroimaging techniques, we intend to investigate the functional activation pattern after afferent tibialis nerve stimulation as well as the association with the architecture of the sacral roots. We aime to get a better insight into functional neuromodulation and central nervous processing. The study aim is to evaluate the feasibility in healthy subjects as a pilot study for the application of these method in patients with chronic, incomplete spinal cord injury.

NCT ID: NCT03906721 Completed - Clinical trials for Spinal Cord Injuries

Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury

Start date: February 20, 2019
Phase: Phase 2
Study type: Interventional

The use of conditioning open-label placebo (COLP) 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 dose to diminish adverse effects as well as the risk of addiction associated with narcotic treatment.