NCT06643312 TPAD for Recovery of Standing After Severe SCI
| NCT ID | NCT06643312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | SCI - Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-10-22 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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)
Contact & Investigator
Gail F Forrest, PhD
PRINCIPAL INVESTIGATOR
Kessler Foundation
Frequently Asked Questions
Who can join the NCT06643312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SCI - Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06643312 currently recruiting?
Yes, NCT06643312 is actively recruiting participants. Contact the research team at LMartinez@KesslerFoundation.Org for enrollment information.
Where is the NCT06643312 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT06643312 clinical trial?
NCT06643312 is sponsored by Kessler Foundation. The principal investigator is Gail F Forrest, PhD at Kessler Foundation. The trial plans to enroll 50 participants.