Using a robotic device to improve standing after spinal cord injury
Official title: Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
Run by Kessler Foundation · NCT06643312 · Data updated 2026-11-12
This study is testing a robotic device to see if it can help people with spinal cord injuries improve their ability to stand and balance.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Status | Recruiting |
| Started | October 22, 2024 |
| Main results expected | October 2027 |
| Study ends | January 2028 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06643312 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with stable, non-progressive traumatic spinal cord injuries above T10, either able to stand independently or unable to do so.
✕Probably not a fit
Patients with untreated musculoskeletal issues, severe dysautonomia, or those unwilling to discontinue anti-spasticity medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of a robotic assistive device called the Tethered Pelvic Assist Device (TPAD) on standing and sitting balance control in individuals with spinal cord injury (SCI). Participants will be classified into five groups based on their ability to stand independently and will undergo training with the TPAD to enhance muscle function and posture control. The TPAD provides active support and controlled perturbations to challenge participants' balance, aiming to improve their overall standing ability. A total of 50 participants will be enrolled, with assessments conducted over a six-month period.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the ability of individuals with spinal cord injuries to stand and maintain balance, improving their quality of life.
How similar studies have gone: While the use of robotic devices for rehabilitation is an emerging field, this specific approach with the TPAD is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Kessler Foundation
West Orange, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Gail F Forrest, PhD — Kessler Foundation
- Study coordinator: Research Manager
- Email: LMartinez@KesslerFoundation.Org
- Phone: 9733243557
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.