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Developmental Disability clinical trials

View clinical trials related to Developmental Disability.

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NCT ID: NCT06407219 Recruiting - Physical Disability Clinical Trials

Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

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

Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.

NCT ID: NCT06259201 Recruiting - Clinical trials for Autism Spectrum Disorder

Vagus Nerve Stimulator for Autism and Other Developmental Disorders

VNS
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The goal of this flexible single-subject design vagus nerve stimulation (VNS) study is to examine the behavioral, cognitive, and biorhythmic effects of VNS in children and adults with autism and developmental disabilities. The main aims are: - Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials. - Examine the effects of VNS on a broad range of symptoms. Participants will select between 1, 2, or 3 months of daily VNS treatment and complete study visits each month.

NCT ID: NCT06161168 Recruiting - Stroke Clinical Trials

Bootle Blast: Understanding the Family Experience

Start date: July 7, 2022
Phase: N/A
Study type: Interventional

One in 60 children have a physical disability that can impact activities and participation. Occupational and physical therapies can be of great benefit, but are costly and difficult to access. Working with children, parents and clinicians, the investigators developed a mixed reality video game, Bootle Blast, which children can play to develop motor skills. Using a 3D sensor, Bootle Blast tracks movements and manipulation of real-life objects. Since 2017, Bootle Blast has been used in clinics by Holland Bloorview, Canada's largest children's rehabilitation hospital. Home use of Bootle Blast has resulted in positive clinical outcomes for children with cerebral palsy. Bootle Blast is not yet commercially available and has yet to be trialed in "real-world" contexts. To understand real-world implementation, Bootle Blast will be trialed for 14 weeks in the homes of 60 young people (6 to 17 years) with any motor condition that could be addressed by the Bootle Blast system, regardless of their diagnosis. The investigators will assess feasibility (e.g. independent home setup, ability to set/meet self-directed play time goals), enablers/barriers to use, and perceived value. User experience will inform product, training and resource development. The research team combines expertise in engineering design, medicine, physiotherapy, qualitative methods, commercialization, knowledge translation, and includes young people with lived experience.

NCT ID: NCT05987761 Recruiting - Autism Clinical Trials

PRT for Adolescents With High Functioning Autism

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

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).

NCT ID: NCT05935982 Recruiting - Physical Inactivity Clinical Trials

Virtual Reality Exercise in a Community Highschool for Children With Disabilities

Start date: September 18, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to work with a community engagement group to develop and pilot a protocol for a virtual reality exergaming program for children with special needs at a high school.

NCT ID: NCT05909670 Recruiting - Parenting Clinical Trials

FASTT Telehealth Behavioral Support Service for Caregivers of Children With Developmental Delay or Disability

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

Over 7 million children in the U.S. receive support for a developmental delay or disability (DD). For caregivers of these children, behavior issues that often accompany their child's condition create high levels of stress leading to increased mental and physical health issues and impacts on caregiver-child interactions and family functioning. Although evidence-based practices exist to help caregivers with their child's behavioral development, access to these services is often limited by rigid delivery models requiring in-person visits that can delay support and further increase the burden on families. These barriers are disproportionately higher for families of color and for those in low resource situations: an effect that has been exacerbated by reductions in services due to coronavirus disease 2019 (COVID-19). The overall objective of this project is to develop and implement a telehealth delivery model of rapid-response, evidence-based behavioral support to be provided in conjunction with an existing family navigation program (Undivided) serving parents of children with DD to create a commercially marketable product that will reduce barriers to services in local communities across the country. This project will test the feasibility and acceptability of the Family Advice Text and Telephone (FASTT) support service for caregivers of young children. This Phase 1 application will enable a collaborative process to adapt evidence-based behavioral support to the specific needs of families of children ages birth to 12 with DD and integrate that support within the existing family navigation service. The rationale for the work is that providing effective, personalized support through the widely accessible mediums of text and telephone will get caregivers the help they need when and where they have time to access it and close in time to the behavioral issues they need help with, thus reducing caregiver stress and increasing their sense of competence and positive interactions with their child. Aim 1 determines the feasibility of delivering evidence-based behavioral support to caregivers of children with disabilities using on-demand text messaging. Aim 2 gauges the acceptability of the text-based support service to caregivers. Aim 3 assesses the extent to which text-based support reduces caregiver stress, improves caregiver sense of competence, and builds more positive perceptions of their child's behavior and their relationship with their child.

NCT ID: NCT05849285 Recruiting - Cerebral Palsy Clinical Trials

Evaluation of the Transitional and Lifelong Care Program

Start date: January 3, 2024
Phase:
Study type: Observational

The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a "cliff" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.

NCT ID: NCT05744479 Recruiting - Obesity Clinical Trials

Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

METIDD
Start date: February 28, 2023
Phase: Phase 4
Study type: Interventional

People with IDD (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. While antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with IDD. Exercise and diet interventions have limitations and may not be sufficient, requiring effective adjunctive pharmacological approaches to target obesity and related comorbidities in IDD. However, persons with IDD treated with antipsychotics are systematically excluded from clinical trials hindering development of evidence to help guide safe and effective treatment of these comorbidities. Moreover, evidence from other disorders cannot be extrapolated to IDD given inherent biological differences between disorders. This trial will address the identified gaps, which extend beyond cardiovascular morbidity and negatively impact psychosocial outcomes, in a hugely underserviced population.This is the the first RCT (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with IDD who have experienced antipsychotic-induced weight gain. By generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.

NCT ID: NCT05336955 Recruiting - Clinical trials for Developmental Disability

Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities

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

Roughly 40% of those with intellectual and developmental disabilities (IDD) have mental health needs, which is twice the national average. Nevertheless, there is dearth of evidenced-based mental health treatment for youth and young adults with IDD. The disparity in access to mental health care places those with IDD at greater risk of crisis service use. While telemental health studies demonstrate potential to enhance access to care, little of this research includes those with IDD, or crisis prevention and intervention. This project will refine and evaluate telemental health services for youth and young adults with IDD delivered within START (Systemic, Therapeutic, Assessment, Resources, and Treatment), a national, evidence-based model of crisis prevention and intervention for people with IDD. The study will begin with stakeholder feedback (service recipients, families, and providers) regarding telemental health services (Aim 1). Results will be used to refine the intervention. Our team will then compare telemental health versus in-person START services in a randomized control trial (Aim 2). To our knowledge, this will be the first trial of a telemental health crisis program for the IDD population. The final goal is to understand if outcomes vary across subpopulations (Aim 3) and to identify potential disparities. If found, the investigators will work with service users, families and providers to develop a strategy to address identified disparities in outcomes. The study will be executed by an interdisciplinary team of experts engaged with stakeholder partners. Understanding the benefits of specific telemental health methods has important implications to the design of interventions, within and outside of START. This telemental health study offers promise to address disparities in access to mental health care for people with IDD.

NCT ID: NCT05295277 Recruiting - Clinical trials for Autism Spectrum Disorder

Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort

Start date: November 30, 2020
Phase:
Study type: Observational

The purpose of this research use only (RUO) study is to detect genomic structural variants (SVs) in human DNA by Optical Genome Mapping (OGM) using the Bionano Genomics Saphyr system. SVs are a type of genetic alternation that includes deletions, duplications, and both balanced and unbalanced rearrangements (ex: inversions or translocations), as well as specific repeat expansions and contractions. The results of OGM analysis will be compared to prior clinical genetic test results to determine how OGM compares to current standard of care (SOC) clinical test methods such as chromosomal microarray analysis (CMA), karyotyping, Southern blot analysis, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), and/or next generation sequencing (NGS), etc.