Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650202
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
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:
The purpose of this study is to understand how standing and sitting balance control is altered after spinal cord injury and how a new type of robotic assistive device may be used with spinal stimulation to improve muscle function The investigators will be testing a device called the Tethered Pelvic Asist Device or TPAD in this study The TPAD may be helpful in two ways It can be used to help control and support of the trunk pelvis and knees during stand training Also the TPAD can be used as a training tool by providing controlled pushes or perturbations that must be corrected by the person with spinal cord injury in order to maintain proper posture and upright balance This could be helpful for improving muscle function after spinal cord injury
Participants will be placed into one of two groups based on availability and preference Group 1 will receive TPAD training with stimulation and assessments with and without stimulation Participation in this group lasts approximately 4 months Group 2 will only receive assessments with and without stimulation Participation in this group last approximately 3 weeks
Participants will be placed into one of two groups based on availability and preference Group 1 will receive TPAD training with stimulation and assessments with and without stimulation Participation in this group lasts approximately 4 months Group 2 will only receive assessments with and without stimulation Participation in this group last approximately 3 weeks
Detailed Description:
The aims of the proposed study are to a examine the muscle activation patterns generated during stable and perturbed standing in spinal cord injured individuals using spinal cord epidural stimulation scES and robotic TPAD-assistance or self-assistance for balance and b and c to examine the effectiveness of TPAD-assisted stand training in the improvement of postural control during stable and perturbed standing and sitting in spinal cord injured individuals using spinal cord epidural stimulation scES
The Tethered Pelvic Assist Device TPAD is a light-weight cable-driven robotic stand trainer that i can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area and ii can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing
A total of 20 spinal cord injured participants who were previously implanted with a scES unit will be enrolled in this study They will be split into two groups with 10 participants in each All participants will undergo a physical examination and classification of their spinal cord injury to determine eligibility criteria which are the same for both groups Participants will then be placed into one of the two groups based on their availability and preference to be enrolled in a longer or shorter study Group 1 will consist of individuals with SCI and an scES implant that will receive TPAD training with stimulation and assessments with and without stimulation Group 2 will consist of individuals with SCI and an scES implant that will only receive assessments with and without stimulation
Each individual will serve as their own control to reduce variability All participants will undergo the Stable Standing Assessment Postural Perturbation Assessment Stable Sitting Assessment and Postural Perturbation Assessment in Sitting Only Group 1 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system
The Tethered Pelvic Assist Device TPAD is a light-weight cable-driven robotic stand trainer that i can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area and ii can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing
A total of 20 spinal cord injured participants who were previously implanted with a scES unit will be enrolled in this study They will be split into two groups with 10 participants in each All participants will undergo a physical examination and classification of their spinal cord injury to determine eligibility criteria which are the same for both groups Participants will then be placed into one of the two groups based on their availability and preference to be enrolled in a longer or shorter study Group 1 will consist of individuals with SCI and an scES implant that will receive TPAD training with stimulation and assessments with and without stimulation Group 2 will consist of individuals with SCI and an scES implant that will only receive assessments with and without stimulation
Each individual will serve as their own control to reduce variability All participants will undergo the Stable Standing Assessment Postural Perturbation Assessment Stable Sitting Assessment and Postural Perturbation Assessment in Sitting Only Group 1 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system
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