An interventional study of The Tethered Pelvic Assist Device (TPAD) in SCI - Spinal Cord Injury, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Supportive care
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:
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:
Group 2:
Group 3:
Group 4:
Group 5:
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 50 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
* 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
Device: The Tethered Pelvic Assist Device (TPAD)
* 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
Device: The Tethered Pelvic Assist Device (TPAD)
* Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks
* Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks
* Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks
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.
Sitting Assessment
Research participants will sit on a padded table and perform tasks to challenge their balance control (reaching/shifting weight in multiple directions). Assistance for sitting will be provided at the trunk by the TPAD or by the trainer. EMG and kinematic analysis will be performed on the lower extremities, trunk and upper extremities during sitting. The trunk force and position controller data from the TPAD will be also collected; these data will be synchronized with EMG and kinematic data. Muscle activation patterns will be evaluated recording EMG from different muscle groups. The TPAD/trainer will then generate controlled loss of balance during sitting. EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance will be compared. EMG mean and integrated amplitudes from each muscle will be compared before and after training. Relationships between these parameters will also be calculated and compared with non-disabled data.
Time frame: On average 4 hours to complete. Done at the beginning of the study for groups 1, 2, and 5. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Neuromuscular Recovery Scale (NRS)
Research participants will undergo a series of tasks to test the level of muscle activation and amount of assistance required during standing and stepping in a body-weight supported treadmill environment, as well as overground motor tasks. Arm, trunk/leg movement recovery and independency will be measured by the NRS using 14 motor tasks (sit, reverse sit up, sit up, sitting truck extension, overhead press, forward reach and grasp, door pull and open, can open and manipulation, sit to stand, stand, walking, stand adaptability, step retraining, and step adaptability) and combined with EMG, kinematic, and kinetic analyses on the upper and lower extremities and/or trunk. Based on the performance across categories, 4 phase scores can be assigned:1- greatest impairment relative to normal movement patterns (non-ambulatory), 2- begins to stand and weight support independently, 3- walking with varying skill levels, and 4- normal locomotor and transfer performance with adaptability.
Time frame: On average, 2 hours to complete. Groups 1 and 2 will complete the NRS at the beginning of the study and at the end (on average 6 months).
Standing Assessment
Participants will stand as long as possible and undergo a series of standing tasks. Electromyography (EMG), kinematic and kinetic analysis will be performed on the lower extremities and trunk during standing. The pelvic, trunk and knee force and position controller data from the TPAD will be collected and synchronized. Muscle activation patterns will be evaluated recording EMG from different muscle groupings. When appropriate, ground reaction forces will be measured. Blood pressure and heart rate will be measured. The TPAD will then generate controlled loss of balance during standing. Participants will regain balance with/without grasping a fixed object. Investigators will compare EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance if applicable. EMG mean and amplitudes from each muscle will be compared before and after training. The relationship between these parameters will also be calculated and compared with non-disabled data.
Time frame: On average 4 hours to complete. Done at the beginning of the study for all groups. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Plan to share: No — All Individual Participant Data (IPD) will be kept with the study research team at Kessler Foundation. IPD will be de-identified and may be shared with the device research team at Columbia University, the FDA, Kessler Foundation Institutional Review Board, the Department of Health and Human Services, and collaborators at the Kentucky Spinal Cord Injury Research Center.
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