Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
This study is looking at how a robotic device called the Tethered Pelvic Assist Device (TPAD) can help improve balance in people with spinal cord injury (SCI) who also have an implanted spinal cord epidural stimulation unit. The TPAD can help support your body while standing and can also gently push you off balance to help you practice regaining your posture. Researchers want to see how using the TPAD with spinal stimulation affects muscle activity and improves your ability to control your balance while sitting and standing. To join, you must be at least 18 years old, have a stable spinal cord injury for at least a year, and have an implanted spinal cord epidural stimulation unit that can be updated. The study plans to enroll 20 participants.
- Study design
- This study is an interventional study with 20 participants who will be split into two groups. The phase of the study is not specified.
- What's involved
- You will undergo physical examinations and assessments of your sitting and standing balance. These assessments can take up to 4 hours each and will be done at the beginning and end of the study, and up to 4 times during training for one group.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your neuromuscular recovery will be measured at the beginning and end of the study (on average, 4 months for one group).
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Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Principal Investigator · PRINCIPAL_INVESTIGATOR · Kessler Foundation
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Neuromuscular Recovery Scale (NRS)On average, 2 hours to complete. Group 1will complete the NRS at the beginning of the study and at the end (on average 4 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.
- Sitting AssessmentOn average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times.
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 between the beginning and end of the study.
- Standing AssessmentOn average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times.
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 the study.