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.
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
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.
Parallel
Body Weight Supported Treadmill Training
Procedure/SurgeryFor these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.
10 Meter walk test
Used to assess walking speed, time taken to walk 10 meters at fastest pace
6 Minute Walk test
Used to assess distance traveled during a 6 minute walking test at a self selected pace
Walking Index for spinal cord injury
Assessment to determine the physical assistance and assistive devices needed to walk 10 meters
Daily step counts
Step counts from a waist worn activity tracker
Gait Deviation idex
A measure of gait quality by quantifying joint angles during a gait cycle. This data is recorded via a marker-less motion capture system
Click on the lead sponsor to view all of their trials.
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
