Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-75
SponsorMilap Sandhu

About this trial

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.

The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Body Weight Supported Treadmill Training

Treatment groups

108 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Milap Sandhu

Lead sponsor

Shirley Ryan AbilityLab

Sponsor institution

Baylor Scott and White Health

Collaborator

University of Florida

Collaborator

Congressionally Directed Medical Research Programs

Collaborator