Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643312
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
TPAD for Recovery of Standing After Severe SCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
Status:
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 investigate how standing and sitting balance control is altered after spinal cord injury SCI and how a new type of robotic assistive device may be used to improve muscle function This device is called the Tethered Pelvic Assist Device or TPAD
The main aims are to
1 Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance
2 and 3 Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals
Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury
Group 1
Individuals with SCI that can stand independently
Will receive TPAD training
Will undergo standing posture sitting and stepping assessments
Participation in this group will last about six months
Group 2
Individuals with SCI that cannot stand independently
Will receive TPAD training
Will undergo standing posture sitting and stepping assessments
Participation in this group will last about 6 months
Group 3
Individuals with SCI that can stand independently
Will undergo standing and posture assessments
Participation in this group will last about 2 weeks
Group 4
Individuals with SCI that cannot stand independently
Will undergo standing and posture assessments
Participation in this group will last about 2 weeks
Group 5
Individuals without a SCI
Will undergo standing posture and sitting assessments
Participation in this group will last about 2 weeks
The main aims are to
1 Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance
2 and 3 Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals
Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury
Group 1
Individuals with SCI that can stand independently
Will receive TPAD training
Will undergo standing posture sitting and stepping assessments
Participation in this group will last about six months
Group 2
Individuals with SCI that cannot stand independently
Will receive TPAD training
Will undergo standing posture sitting and stepping assessments
Participation in this group will last about 6 months
Group 3
Individuals with SCI that can stand independently
Will undergo standing and posture assessments
Participation in this group will last about 2 weeks
Group 4
Individuals with SCI that cannot stand independently
Will undergo standing and posture assessments
Participation in this group will last about 2 weeks
Group 5
Individuals without a SCI
Will undergo standing posture and sitting assessments
Participation in this group will last about 2 weeks
Detailed Description:
The investigators will be testing a device called the Tethered Pelvic Assist Device or TPAD The TPAD provides active control and support of the trunk pelvis and knees during training to improve the ability to stand Also the TPAD can be used to safely challenge participants during standing by providing controlled pushes or perturbations that must be corrected for in order to maintain proper posture and upright balance This could be helpful for improving muscle function after spinal cord injury
Methodology
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 50 participants will be enrolled in this study they will be broken into five groups with 10 participants in each All participants will undergo a physical classification of their spinal cord injury to determine eligibility and which group they belong in Group 1 will consist of individuals with SCI that can stand independently and will receive TPAD training and assessments Group 2 will consist of individuals with SCI that cannot stand independently and will receive TPAD training and assessments Group 3 will consist of individuals with SCI that can stand independently and will receive assessments only Group 4 will consist of individuals with SCI that cannot stand independently and will receive assessments only and Group 5 will consist of individuals without a SCI that will receive assessments only Each individual will serve as their own control to reduce variability Motor patterns recorded from the SCI research participants will be also compared to those collected from individuals who do not have a SCI All participants will undergo the Stable Standing Assessment and Postural Perturbation Assessment Groups 1 2 and 5 will additionally perform the Stable Sitting Assessment and Postural Perturbation Assessment in Sitting Only Groups 1 and 2 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system
Methodology
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 50 participants will be enrolled in this study they will be broken into five groups with 10 participants in each All participants will undergo a physical classification of their spinal cord injury to determine eligibility and which group they belong in Group 1 will consist of individuals with SCI that can stand independently and will receive TPAD training and assessments Group 2 will consist of individuals with SCI that cannot stand independently and will receive TPAD training and assessments Group 3 will consist of individuals with SCI that can stand independently and will receive assessments only Group 4 will consist of individuals with SCI that cannot stand independently and will receive assessments only and Group 5 will consist of individuals without a SCI that will receive assessments only Each individual will serve as their own control to reduce variability Motor patterns recorded from the SCI research participants will be also compared to those collected from individuals who do not have a SCI All participants will undergo the Stable Standing Assessment and Postural Perturbation Assessment Groups 1 2 and 5 will additionally perform the Stable Sitting Assessment and Postural Perturbation Assessment in Sitting Only Groups 1 and 2 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