Clinical trial NCT06176833: Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
Official title: Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Baylor Scott and White Health
name: University of Florida
First posted: 2023-12-20
Enrollment: 108
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of 4 intervention groups, based around if and when additional walking training is given following injury
Primary purpose: TREATMENT

Brief summary: 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: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 10 Meter walk test
timeFrame: 1-5 days Following Intervention
Secondary outcomes:
measure: 6 Minute Walk test
timeFrame: 1-5 days Following Intervention
measure: Walking Index for spinal cord injury
timeFrame: 1-5 days following intervention
measure: Daily step counts
timeFrame: 2 weeks following 3-, 6-, 9-, and 12- month assessments
measure: Gait Deviation idex
timeFrame: Baseline, 3-, 6-, 9-, and 12- month assessments
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The Shirley Ryan AbilityLab
state: Illinois
city: Fort Worth
country: United States
facility: Baylor Scott and White Institute for Rehabilitation
state: Texas
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Milap Sandhu, PhD
role: PRINCIPAL_INVESTIGATOR
References: