What this study is
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
What's being tested
- The Tethered Pelvic Assist Device (TPAD)
Intervention · DEVICE
a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
Study details
- Official title
- Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
- Sponsor
- Kessler Foundation
- Conditions
- SCI - Spinal Cord Injury
- Enrolling
- 50 people
- Starts
- 2024-10-22
- Est. completion
- 2028-01
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openKessler Foundation
West Orange, New Jersey, United States
- Research Manager · Contact973-324-3557LMartinez@KesslerFoundation.Org
Recruiting
Study team
Sponsor
Kessler Foundation
Study ID R-1232-23
Principal investigator
Gail F Forrest, PhD
Kessler Foundation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.