NCT06650202 Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
| NCT ID | NCT06650202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | SCI - Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-11-01 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 stimulation and assessments with and without stimulation. Participation in this group lasts approximately 4 months. Group 2 will only receive assessments with and without stimulation. Participation in this group last approximately 3 weeks.
Eligibility Criteria
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.
Contact & Investigator
Principal Investigator
PRINCIPAL INVESTIGATOR
Kessler Foundation
Frequently Asked Questions
Who can join the NCT06650202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SCI - Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06650202 currently recruiting?
Yes, NCT06650202 is actively recruiting participants. Contact the research team at LMartinez@KesslerFoundation.Org for enrollment information.
Where is the NCT06650202 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT06650202 clinical trial?
NCT06650202 is sponsored by Kessler Foundation. The principal investigator is Principal Investigator at Kessler Foundation. The trial plans to enroll 20 participants.