Clinical Trials Logo

Spinal Dysraphism clinical trials

View clinical trials related to Spinal Dysraphism.

Filter by:

NCT ID: NCT05726591 Recruiting - Cerebral Palsy Clinical Trials

Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Background: People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training. Objective: To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder. Eligibility: People aged 3 to 17 years with a gait disorder involving the knee joint. Design: Participants will be screened. They will have a physical exam. Their walking ability will be tested. Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength. The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy. During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches. During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks. Participants walking ability will be retested after each phase....

NCT ID: NCT05719636 Completed - Spina Bifida Clinical Trials

Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida

Start date: May 13, 2022
Phase: N/A
Study type: Interventional

In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.

NCT ID: NCT05718440 Recruiting - Spinal Dysraphism Clinical Trials

Uronephrological Complications Risk Factors in Spinal Dysraphism

RUD
Start date: November 6, 2023
Phase:
Study type: Observational

Spinal dysraphism consist of congenital malformations resulting of abnormalities in the formation of neural tube and/or surrounding structures during embryogenesis. The aim of this study is to assess if there are specific clinical and paraclinical patterns of pelvic (urinary, bowel, sexual) disorders depending on the dysraphism's type and level of injury. This description will help to determine a prognosis on symptoms and the risk of complication depending on the dysraphism's type and level of injury. It will provide targeted evaluation and cares: identifying patients who will be at risk of complications and needing acute monitoring or preventing cares on the symptoms' onset. Pelvic disorders have an important impact on morbi-mortality (urinary dysfunction is the first cause of mortality in adults by renal failure or infection) and also on patients' quality of life.

NCT ID: NCT05711355 Completed - Clinical trials for Meningomyelocele/Spina Bifida

the Effects of Platelet-Rich Plasma on Postoperative Complications After Meningomyelocele

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

Introduction: Meningomyelocele is a common congenital neural tube defect. To reduce complications, early surgery and a multidisciplinary approach is needed. In this study, the investigators administered platelet-rich plasma (PRP) to newborns with meningomyelocele following corrective surgery to minimize cerebrospinal fluid (CSF) leakage and accelerate the healing of the immature pouch tissue. The investigators compared these with a control group that did not receive PRP. Patients and Methods: Of the 40 newborns who were operated on with the diagnosis of meningomyelocele, 20 patients received PRP after surgical repair, and 20 were followed up without PRP. In the PRP group, 10 of the 20 patients underwent primary defect repair, the other 10 underwent flap repair. In the group that did not receive PRP, primary closure was performed in 14 patients and flap closure in six.

NCT ID: NCT05672849 Recruiting - Neural Tube Defects Clinical Trials

Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.

NCT ID: NCT05615402 Recruiting - Cerebral Palsy Clinical Trials

Intervention on Bone Health in Wheelchair Users

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

The low mechanical loading of bones among wheelchair users leads to an increased risk of bone fractures and associated complications due to low bone mineral density (BMD). Adding mechanical loading through physical activity in combination with optimizing nutrition may counteract these negative consequences in wheelchair users and thereby provide positive impact for bone health, as well as for physical and mental health. In this project, a multidisciplinary team will tailor a bone-specific exercise and nutrition program to increase BMD in sport active and non-active wheelchair users with initial low BMD.

NCT ID: NCT05587634 Active, not recruiting - Cerebral Palsy Clinical Trials

Virtual Peer Health Coaching for Adolescents With Disabilities

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

Participation in physical activity (PA) confers clear physical and psychosocial benefits. Yet, many adolescents with physical disabilities such as cerebral palsy and spina bifida do not engage in regular PA, putting them at increased risk for the detrimental impact of sedentary lifestyles such as high rates of obesity/overweight - adverse health trends that continue into adulthood. To address this PA gap, a feasibility pilot randomized controlled trial is proposed evaluating the utility of a peer health coach intervention to promote PA participation and to improve outcomes related to self-autonomy, self-efficacy, and quality of life in adolescents with physical disabilities. Peer health coaches will themselves be young adults with disabilities, trained in concepts of motivational interviewing and self-determination theory, enabling them to meet participants "where they are at" in their understanding of PA and readiness to change PA behaviors. This study will be novel given that: 1) for the first time, an adult peer health coaching model targeting PA will be adapted to the needs of adolescents with disabilities, 2) the study will employ text messaging and other social media platforms that are highly relevant to an adolescent population, and 3) the study will assess PA participation with use of ActiGraph activity trackers, designed to monitor both duration and intensity of PA in individuals with mobility impairment. The results of this study will be used to inform the design of a future, definitive RCT evaluating the efficacy of a peer health coaching intervention to create meaningful change in physical and psychosocial outcomes. By empowering adolescents with disabilities to take control of their own physical and psychosocial health, this work has the potential to impact the well-being and quality of life of participants for many years to come.

NCT ID: NCT05562713 Completed - Neurogenic Bladder Clinical Trials

CIC Behavioral Economics in Children With Spina Bifida

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

The purpose of the study is to develop a comprehensive program to increase early initiation of self-catheterization in children with Spina Bifida. This will be a prospective open label randomized control trial. Patients and caregivers/guardians in the intervention arm will be enrolled in a comprehensive program that utilizes behavioral economic theory to incentivize initiation of independent CIC. The study population will be patients aged 4 to 12 years old with diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10). This study will look at behavioral interventions. There are no additional physical risks to participation in the study. Patient demographics will be reported using descriptive statistics. Study team will use Kaplan-Meier curves to demonstrate and compare the probability of achieving independent CIC over time between the study arms.

NCT ID: NCT05500690 Recruiting - Clinical trials for Environmental Exposure

Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies

Start date: October 8, 2023
Phase: N/A
Study type: Interventional

Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure. In this study, the investigators will evaluate how DNA methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. In addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.

NCT ID: NCT05473676 Active, not recruiting - Cerebral Palsy Clinical Trials

Robotic Walking for Children Who Cannot Walk

RoWaCaWa
Start date: July 4, 2022
Phase: N/A
Study type: Interventional

A common problem among children with nervous system disorders is difficulty walking on their own. This has impacts beyond mobility including short and long-term health conditions associated with physical inactivity and different developmental experiences as a result of the mobility impairments. A robotic trainer can both provide rehabilitation and be an assistive device to help compensate for difficulties. Figuring out how to prescribe it is critical to improve daily life for children with significant disabilities. Preliminary use of robotic trainers have shown many benefits, such as better head control and improved independence in transfers, which greatly increases ability to live independently. Additionally, vital functions that are frequently impaired in those with less physical activity, such as sleep and bowel habits, seem to improve. Finally, these children enjoy using them. This project aims to determine who is most likely to benefit from training with a robotic trainer and investigate key details about the dose of training that is needed. Families that are already using or hope to use robotic training need this data to help improve their access to the intervention. Clinicians need this systematic approach to building evidence to ensure a future multi-centre randomized control trial is well designed. This study is needed to help improve the lives of those who live with significant disabilities. The objective is to evaluate the feasibility and impacts of delivering robotic gait training at home. Integral in this study is capturing the user perspectives. This will both provide preliminary evidence-based advice to potential users, their families, and clinicians as well as provide key metrics to design a definitive multi-centre randomized control trial. The investigators will provide robotic gait trainers, specifically Trexo robotic gait trainers, to participants and their families to use in their home communities for 12 weeks to evaluate the feasibility and impacts of intensive robotic gait training in people who cannot walk independently. Assessments will be completed throughout the duration of study, including before, during, and after the training intervention, with the goal of evaluating a wide range of feasibility considerations and impacts from robotic training.