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

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT06650202
Status
Recruiting
Apply to this trial

Conditions

  • SCI - Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The Tethered Pelvic Assist Device (TPAD) — DEVICE
    a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
Nov 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Group 1- Training and Assessments
    10 SCI participants with an scES implant that will receive 40-60 TPAD training sessions with stimulation and 5 assessments with and without stimulation.
  • No Intervention: Group 2- Assessments Only
    10 SCI participants with an scES implant that will receive 4 assessments with and without stimulation.

Primary Outcome Measure

Neuromuscular Recovery Scale (NRS) [ Time Frame: On average, 2 hours to complete. Group 1will complete the NRS at the beginning of the study and at the end (on average 4 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Research Manager
[email protected]
9733243557

Find similar trials in West Orange, NJ

By research site
Kessler Foundation· West Orange, NJ

Related Studies