Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKessler Foundation

About this trial

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

Qualifiers

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.

Disqualifiers

unwilling to discontinue from anti-spasticity medications

Untreated painful problems with joints, muscles or bones.

Unhealed fracture.

Pressure sore or urinary tract infection.

Trial design

Treatments tested in this trial

  • The Tethered Pelvic Assist Device (TPAD)

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators