Actively Recruiting
Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
Led by Kessler Foundation · Updated on 2025-04-30
20
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Stable medical condition
- Spinal cord injury caused by trauma lasting at least one year and not worsening
- Implanted spinal cord epidural stimulation unit eligible for software upgrade from a previous study
- Unable to stand independently with epidural stimulation turned off
You will not qualify if you...
- Unwilling to discontinue anti-spasticity medications
- Untreated painful problems with joints, muscles, or bones
- Unhealed fracture
- Pressure sore or urinary tract infection
- History of bone disease (except decreased bone mineral density due to spinal cord injury)
- Ongoing drug abuse
- Untreated psychiatric disorders or clinical depression
- Botox injections in lower extremities within prior six months
- Heart or lung disease interfering with assessments
- Untreated severe problems regulating blood pressure, heart rate, body temperature, or other automatic functions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
R
Research Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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