Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647082
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Engaging Kids With Robotic Exoskeletons and Gamification
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Engaging Kids and Improving Rehab Outcomes by Gamification of Robotic Exoskeletons Combined With Proprioceptive Biofeedback
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Conduct a clinical field trial at CHOAs Day Rehab Program using the clinical exoskeleton in conjunction with visual biofeedback with pediatric patients who present with genu recurvatum or crouch gait over 5 rehabilitation visits
Detailed Description:
For children mobility is a crucial activity of daily living and age-appropriate play influencing their independence and overall quality of life However children with physical disabilities often experience participation restrictions especially related to physical activity The ICF International Classification of Functioning Disability and Health notes that participation is a key contributor toward a persons overall quality of life However children with disabilities often experience significant participation restrictions especially related to physical activity with some studies citing that less than half of children with disabilities are physically active Participation in physical activity allows for all the benefits associated with social engagement belonging and autonomy influencing a childs independence and overall development Additionally physical activity provides the benefits of improved health related fitness including strength and flexibility For children with gait impairments lack of independence may hinder development and then compound through further loss of mobility Some of the most encountered pediatric pathologies CP Spina Bifida and TBI impact physical mobility and clinical presentations often present with aberrant motor control of the knee Clinical presentations may vary between genu recurvatum or crouch gaits and can be confounded with various lower limb alignment presentations as well These abnormal walking patterns can lead to detrimental long-term effects including increased stress on soft tissue structures which often leads to permanent joint deformity if left untreated reduced locomotion capability independence increased energy expenditure and pain The investigator team has developed an autonomous bilateral research-grade pediatric knee exoskeleton and the investigators data on N10 children show the investigators have addressed an initial need for an effective pediatric knee exoskeleton from previous work However work is still needed to encourage 1 real-world accessibility and usability of the device in a clinic setting outside of the research laboratory 2 long-term retention of the intervention beyond the immediate therapeutic session and 3 fun and active patient engagement during exoskeleton use In this study the investigators aim to develop and test a clinically friendly pediatric knee exoskeleton integrated with a visual biofeedback video game to improve gait related outcomes and contribute toward improved mobility in children with walking impairment Early intervention to engage children in their rehab along with enjoyable participation may lead to improved long-term outcomes for children and their families
The investigators will conduct a small-scale feasibility study in which N5 patient participants will undergo 5 sessions of experimental therapeutic rehabilitation sessions with the exoskeleton and the visual biofeedback game Participants will use the device for a maximum of 2 hours per session for 5 sessions Sessions will be scheduled as is convenient for the participants schedule with a goal of having one night and no more than 1 week between consecutive sessions Outcomes will be monitored before and after each session
The investigators hypothesize that patient outcomes inclusive of both functional and patient reported metrics will significantly improve from the initial baseline visit to the final evaluation after 5 sessions of therapy Finally the investigators will analyze the device efficacy and familytherapist survey data to implement improvements to the exoskeleton and biofeedback game in the future
The investigators will conduct a small-scale feasibility study in which N5 patient participants will undergo 5 sessions of experimental therapeutic rehabilitation sessions with the exoskeleton and the visual biofeedback game Participants will use the device for a maximum of 2 hours per session for 5 sessions Sessions will be scheduled as is convenient for the participants schedule with a goal of having one night and no more than 1 week between consecutive sessions Outcomes will be monitored before and after each session
The investigators hypothesize that patient outcomes inclusive of both functional and patient reported metrics will significantly improve from the initial baseline visit to the final evaluation after 5 sessions of therapy Finally the investigators will analyze the device efficacy and familytherapist survey data to implement improvements to the exoskeleton and biofeedback game in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None