Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury (PROPEL-SCI)

Milap Sandhu

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Procedure: Body Weight Supported Treadmill Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06176833

STU00219541

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 4 patient groups

Early Intervention

Active Comparator group

Description:

Additional training will begin no more than 60 days following spinal cord injury

Treatment:

Procedure: Body Weight Supported Treadmill Training

Sub-acute Intervention

Active Comparator group

Description:

Additional training will occur 3 months following spinal cord injury

Treatment:

Procedure: Body Weight Supported Treadmill Training

Chronic Intervention

Active Comparator group

Description:

Additional training will occur 6-12 months following SCI

Treatment:

Procedure: Body Weight Supported Treadmill Training

Standard of Care

No Intervention group

Description:

This group only receives standard of care treatment but is assessed at the same time points as the other groups