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New treatment option for SCI - Spinal Cord Injury
Official title TPAD for Recovery of Standing After Severe SCI
ClinicalTrials.gov ID: NCT06643312
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- At least 18 years of age at the time of enrollment;
- stable medical condition
- at least one year post-spinal cord injury (Groups 1-4)
- non-progressive, traumatic SCI above T10 (Groups 1-4)
- Injury Grade A, B, C or D (Groups 1-4)
You likely can't join if
- unwillingness to wean from anti-spasticity medications;
- untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
- history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
- ongoing drug abuse
- untreated psychiatric disorders or clinical depression
- received botox injections in lower extremities in the prior six months
See the full eligibility criteria
- At least 18 years of age at the time of enrollment;
- stable medical condition
- at least one year post-spinal cord injury (Groups 1-4)
- non-progressive, traumatic SCI above T10 (Groups 1-4)
- Injury Grade A, B, C or D (Groups 1-4)
- ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3)
- inability to stand independently (Groups 2 and 4)
- unwillingness to wean from anti-spasticity medications;
- untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
- history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
- ongoing drug abuse
- untreated psychiatric disorders or clinical depression
- received botox injections in lower extremities in the prior six months
- Cardiopulmonary disease that may interfere with assessments
- Untreated severe and persistent dysautonomia
- Neurological injury or disease (Group 5)
- Orthopedic injury or condition (Group 5)
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.