TPAD for Recovery of Standing After Severe Spinal Cord Injury
This study is investigating a new robotic device called the Tethered Pelvic Assist Device (TPAD) to help people with spinal cord injury (SCI) improve their standing and sitting balance. The TPAD is a lightweight device that can assist you by applying gentle forces to your trunk and pelvis, or it can challenge you with controlled "pushes" to help strengthen your muscles. Researchers want to see how the TPAD affects muscle activity and whether it can improve your ability to control your posture while standing and sitting. You might be able to join if you are at least 18 years old, have a stable medical condition, and had a traumatic SCI above T10 at least one year ago. The study aims to enroll 50 participants.
- Study design
- This interventional study plans to enroll 50 participants, divided into five groups of 10. The study will test the Tethered Pelvic Assist Device (TPAD).
- What's involved
- You would undergo a physical classification of your spinal cord injury. Assessments of sitting, neuromuscular recovery, and standing will be done at the beginning and end of the study (around 6 months), with some repeated during training (up to 4 times).
- Compensation
- Not stated in the trial record.
- Follow-up
- Assessments will be completed at the end of the study, which is on average 6 months after the beginning.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
TPAD for Recovery of Standing After Severe SCI
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Gail F Forrest, PhD · PRINCIPAL_INVESTIGATOR · Kessler Foundation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Sitting AssessmentOn 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).
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.
- Neuromuscular Recovery Scale (NRS)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).
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.
- Standing AssessmentOn 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).
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.