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TPAD for Recovery of Standing After Severe SCI

Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

1. At least 18 years of age at the time of enrollment;
2. stable medical condition
3. at least one year post-spinal cord injury (Groups 1-4)
4. non-progressive, traumatic SCI above T10 (Groups 1-4)
5. Injury Grade A, B, C or D (Groups 1-4)
6. ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3)
7. inability to stand independently (Groups 2 and 4)

Exclusion Criteria:

1. unwillingness to wean from anti-spasticity medications;
2. untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
3. history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
4. ongoing drug abuse
5. untreated psychiatric disorders or clinical depression
6. received botox injections in lower extremities in the prior six months
7. Cardiopulmonary disease that may interfere with assessments
8. Untreated severe and persistent dysautonomia
9. Neurological injury or disease (Group 5)
10. Orthopedic injury or condition (Group 5)

About the study

The purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD.

The main aims are to:

1\. Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance

2 and 3. Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals.

Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury:

Group 1:

* Individuals with SCI that can stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about six months

Group 2:

* Individuals with SCI that cannot stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about 6 months

Group 3:

* Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks

Group 4:

* Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks

Group 5:

* Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks

What is being tested

• The Tethered Pelvic Assist Device (TPAD) (device)

Sponsor: Kessler Foundation · Participants: 50 · Started: Oct 22, 2024

Contact the study team

• Research Manager · Phone: 9733243557
• Gail F Forrest, PhD · Phone: 9733243518

Official record on ClinicalTrials.gov — NCT06643312

Locations in the U.S.

Conditions

• Spinal Cord Injuries

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.