Recruiting

Robotic Trainer & Epidural Stimulation

Sponsor:

Kessler Foundation

Code:

NCT06650202

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The Tethered Pelvic Assist Device (TPAD)

Study Details

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.

Conditions

SCI - Spinal Cord Injury

Study ID

NCT06650202

Start date

Nov 1, 2024

Status verified date

Oct, 2024

Completion date

Jan, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

The Tethered Pelvic Assist Device (TPAD)

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.

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) ]
  • Sitting Assessment [ Time Frame: On average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times. ]
  • Standing Assessment [ Time Frame: On average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times. ]

Central Contacts and Locations

Central contacts

Research Manager

9733243557LMartinez@KesslerFoundation.Org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Research Manager

9733243557LMartinez@KesslerFoundation.Org

More Information

Sponsor

Kessler Foundation

Last update posted

Apr 30, 2025

Last verified

Oct, 2024

Keywords

  • TPAD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-04-30.