BridgeMD
New treatment option for SCI - Spinal Cord Injury
Official title Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
ClinicalTrials.gov ID: NCT06650202
What this study is testing
- What it's testing
- 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.
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
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
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. 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.