Using a robotic device to improve standing after spinal cord injury
Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
NA · Kessler Foundation · NCT06643312
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kessler Foundation (other) |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT06643312 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with untreated musculoskeletal issues, severe dysautonomia, or those unwilling to discontinue anti-spasticity medications may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
West Orange, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SCI - Spinal Cord Injury, TPAD