NCT06643312 · Kessler Foundation
TPAD for Recovery of Standing After Severe SCI
What this study 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\.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
- West Orange, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2024 · Source of record for eligibility and locations