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TPAD for Recovery of Standing After Severe SCI

RecruitingNAAges 18 Years - anyAllKessler Foundation
NCT06643312 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 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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. At least 18 years of age at the time of enrollment; 2. stable medical condition 3. at least one year post-spinal cord injury (Groups 1-4) 4. non-progressive, traumatic SCI above T10 (Groups 1-4) 5. Injury Grade A, B, C or D (Groups 1-4) 6. ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3) 7. inability to stand independently (Groups 2 and 4) Exclusion Criteria: 1. unwillingness to wean from anti-spasticity medications; 2. untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection 3. history of bone disease unassociated with decreased bone mineral density due to spinal cord injury 4. ongoing drug abuse 5. untreated psychiatric disorders or clinical depression 6. received botox injections in lower extremities in the prior six months 7. Cardiopulmonary disease that may interfere with assessments 8. Untreated severe and persistent dysautonomia 9. Neurological injury or disease (Group 5) 10. Orthopedic injury or condition (Group 5)
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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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