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

Study Overview
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Brief Summary
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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 (explained further below) 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.

Official Title
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Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Procedure: Body Weight Supported Treadmill Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into one of 4 intervention groups, based around if and when additional walking training is given following injury
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Intervention<br>Additional training will begin no more than 60 days following spinal cord injury | Procedure: Body Weight Supported Treadmill Training<br>* For 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.<br>* Other names: BWSTT;|
| Active Comparator: Sub-acute Intervention<br>Additional training will occur 3 months following spinal cord injury | Procedure: Body Weight Supported Treadmill Training<br>* For 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.<br>* Other names: BWSTT;|
| Active Comparator: Chronic Intervention<br>Additional training will occur 6-12 months following SCI | Procedure: Body Weight Supported Treadmill Training<br>* For 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.<br>* Other names: BWSTT;|
| No Intervention: Standard of Care<br>This group only receives standard of care treatment but is assessed at the same time points as the other groups | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 Meter walk test | Used to assess walking speed, time taken to walk 10 meters at fastest pace | 1-5 days Following Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk test | Used to assess distance traveled during a 6 minute walking test at a self selected pace | 1-5 days Following Intervention | 
| Walking Index for spinal cord injury | Assessment to determine the physical assistance and assistive devices needed to walk 10 meters | 1-5 days following intervention | 
| Daily step counts | Step counts from a waist worn activity tracker | 2 weeks following baseline, 3-, 6-, 9-, and 12- month assessments |