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Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation

RecruitingNAAges 18 Years - anyAllKessler Foundation
NCT06650202 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * At least 18 years old * Stable medical condition. * Has a spinal cord injury caused by trauma (fall, car accident, etc.) for at least one year that is not getting worse over time * Has an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study. * Unable to stand independently with epidural stimulation turned off. Exclusion Criteria: * unwilling to discontinue from anti-spasticity medications * Untreated painful problems with joints, muscles or bones. * Unhealed fracture. * Pressure sore or urinary tract infection. * History of bone disease (except for decreased bone mineral density due to spinal cord injury). * Ongoing drug abuse. * Untreated psychiatric disorders or clinical depression. * Received Botox injections in the lower extremities in the prior six months. * Heart or lung disease that may interfere with assessments. * Untreated severe and persistent problems regulating blood pressure, heart rate, body temperature or other automatic functions.
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What it tests

  • The Tethered Pelvic Assist Device (TPAD)
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Where

1 site
Kessler Foundation
West Orange, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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