Improving balance for spinal cord injury patients using a robotic device and stimulation
Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
This study is testing whether a robotic device combined with spinal stimulation can help improve balance in people with spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT06650202 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how balance control is affected after spinal cord injury and to evaluate the effectiveness of a robotic assistive device called the Tethered Pelvic Assist Device (TPAD) in conjunction with spinal cord epidural stimulation. Participants will be divided into two groups to receive either TPAD training with stimulation or assessments without stimulation. The TPAD provides support and corrective forces to help improve muscle function and postural control during standing and sitting. A total of 20 spinal cord injured individuals with an implanted stimulation unit will be enrolled and assessed for their eligibility based on specific criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stable spinal cord injuries who have an implanted spinal cord epidural stimulation unit.
Not a fit: Patients with untreated psychiatric disorders, ongoing drug abuse, or those who have recently received Botox injections in the lower extremities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance balance and muscle function in patients with spinal cord injuries.
How similar studies have performed: While the use of robotic devices and spinal stimulation is a growing field, this specific combination of TPAD and spinal cord epidural stimulation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Principal Investigator — Kessler Foundation
- Study coordinator: Research Manager
- Email: LMartinez@KesslerFoundation.Org
- Phone: 9733243557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.