TPAD for Recovery of Standing After Severe SCI

Recruiting now · Not applicable

Conditions studied: SCI - Spinal Cord Injury

In brief

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

Key facts

Study ID

NCT06643312

Run by

Kessler Foundation

People needed

50

Starts

2024-10-22

Expected to finish

2028-01-01

Last updated by the study team

2024-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Kessler Foundation — West Orange, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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