Actively Recruiting
TPAD for Recovery of Standing After Severe SCI
Led by Kessler Foundation · Updated on 2024-12-16
50
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
TPAD for Recovery of Standing After Severe SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 spinal cord injury above T10 (Groups 1-4)
- Injury Grade A, B, C, or D (Groups 1-4)
- Ability to stand independently for short periods not exceeding 1 hour (Groups 1 and 3)
- Inability to stand independently (Groups 2 and 4)
You will not qualify if you...
- Unwillingness to wean from anti-spasticity medications
- Untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection
- History of bone disease unrelated to decreased bone mineral density from 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)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
R
Research Manager
CONTACT
G
Gail F Forrest, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
5
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