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New treatment option for Spinal Cord Injuries
Official title Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
ClinicalTrials.gov ID: NCT06176833
What this study is testing
- What it's testing
- The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 75
You may be able to join if
- History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
- Between the ages of 16-74
- Weight bearing as tolerated in bilateral lower extremities
- Able to tolerate a harness
- Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
You likely can't join if
- Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
- A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
- Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
- Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
- Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and...
- Pregnancy, as confirmed by blood draw
See the full eligibility criteria
- History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
- Between the ages of 16-74
- Weight bearing as tolerated in bilateral lower extremities
- Able to tolerate a harness
- Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
- Able to provide informed consent within 60 days of injury onset
- Able to participate in all study related activities, including 1-year follow up
- Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
- A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
- Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
- Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
- Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation
- Pregnancy, as confirmed by blood draw
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.