View clinical trials related to Spina Bifida.
Filter by: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.
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.
For children who use a power wheelchair, a powered wheelchair standing device (PWSD) may be considered for daily use. A PWSD allows a child to electronically move between sitting and standing and can be driven in either position. Existing published PWSD research in pediatrics is limited to boys with Duchenne muscular dystrophy (DMD).(1, 2) While these studies provide some insights into PWSD use in boys with DMD, they do not reflect PWSD use in children with other conditions. The purpose of this exploratory study is to determine the feasibility of a research protocol exploring use of a PWSD in children who have neurodevelopmental conditions other than DMD.
Performing surgery in utero on fetuses with certain birth defects has led to significant improvements in outcomes after birth; however, many of these infants are born preterm which can decrease the effectiveness of these procedures. The investigators aim to understand the effects of surgery on the maternal and fetal immune system and whether immune activation may be causing some of these infants to be born prematurely.
Youth with physical disabilities experience greater limitations to participation in community- based activities than do their average-developing peers, which can result in poor health outcomes. Emerging treatment approaches aimed at improving activity and participation have shifted from focusing only on impaired body functions towards the performance of functionally meaningful activities within the youth's natural environment. It is unclear; however, whether targeting intervention at the activity/participation level can simultaneously result in improvement of personal functional skills (e.g., reaching) and body functions (e.g., range of motion, balance) - components known to worsen with age and, thus, important to address and maintain within the rehabilitation process. Our team has partnered with key community-based stakeholders including youth, clinicians and policy-makers, and together we plan to examine whether engaging in an 8-week self-chosen community-based activity (e.g., sledge hockey, boccia) can lead to a significant improvement in three key body functions: motor, cognitive and affective. Thirty youth with physical disabilities will take part in the study and engage in an activity program of their choice. Changes in their body functions (e.g., movement, attention, mood) will be measured multiple times before, during and after engagement in the chosen activity/program. Findings of this study can guide clinicians, families and policy-makers to select effective approaches that not only promote participation but also facilitate additional motor and mental benefits from one single intervention. Such treatment approaches may also reduce the burden on the healthcare system as well as on the youth and families. Moreover, findings can advance our understanding of methods for testing complex and unique 'real-life' individual-based interventions that are highly relevant to practice.
To fetoscopically use cryopreserved human umbilical cord allografts, named NEOX Cord 1K®, as a spinal cord cover of spina bifida defects. This procedure will be performed to create a watertight seal covering over the spinal cord in order to decrease the incidence rates of postnatal morbidities. For larger skin defects, NEOX Cord 1K® may be used as a skin cover.
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.
The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested. **In response to COVID-19, the 12-week M2M intervention and all assessments have been modified from being delivered in-person at Lakeshore Foundation to being delivered remotely in real-time through videoconferencing technology.**
This three year study explores the feasibility and acceptability of conducting a full randomized controlled trial (RCT) of a promising coaching intervention for improving and sustaining physical activity (PA) and healthy dietary habits in children with physical disabilities (CWPD). Thirty children (ages 10 - 18) will spend 12 months in the study. All will receive usual care and basic printed information about healthy lifestyles. In addition, 15 will receive a coaching intervention for the first six months. Pre-defined success criteria will assess the feasibility of trial processes. Acceptability of trial participation and impact of coaching will be explored qualitatively. Health indicators and psychosocial outcomes will be assessed four times, at the start of the trial, immediately post-intervention and at three and six months post-intervention.
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.