After spinal cord injury (SCI), many people lose their ability to walk and do not have access to equipment and assistance that could help them regain functional abilities. Furthermore, many who have the potential to regain function are further hindered by a loss of function in their upper body that limits their ability to use a walker or crutches, thus eliminating options for mobility. This study seeks to determine the safety and feasibility of the XoMotion-R, a self-balancing exoskeleton that allows people with American Spinal Injury Association Impairment Scale (AIS) rating of B-D SCI to walk hands-free in inpatient and outpatient settings. This study will examine how use of the XoMotion-R affects functional outcomes and identify setting-specific barriers and facilitators to clinical adoption. This single-arm feasibility study will recruit 8 SCI inpatients and 8 SCI outpatients whose goal is to improve their walking and incorporate the XoMotion-R into their rehabilitation sessions. Participants will work on a variety of gait tasks tailored to their functional level. The goal is to determine whether early robotic gait training can improve functional outcomes and decrease length of stay, secondary complications, and long-term disability burden.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
The XoMotion-R self-balancing exoskeleton will be utilized for locomotor training in both the inpatient and outpatient setting. Inpatient intervention will be focused on promoting early weight-bearing, postural control, and initiation of step cycles. Training includes progressive walking tasks that emphasize symmetrical lower limb loading, upright posture, and engagement of trunk musculature. In addition to forward ambulation, sessions incorporate functional activities such as sit-to-stand transitions, pivot turns, and standing balance tasks which are all possible with the self-balancing XoMotion-R. The intervention is individualized based on tolerance, cardiovascular response, and patient progress, with adjustments made to walking speed, step length, and assistance levels over time. Outpatient intervention will follow a task-specific approach emphasizing increased walking distance, reduced exoskeleton assistance, and advancement toward community-based ambulation goals. In this phase,
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada
SCI Standing and Walking Assessment (SWAT)
The SWAT will be the primary effectiveness outcome for the inpatient group.
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
6min Walk Test (6MT) (Outpatient group)
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
10-m Walk Test (10MWT) (Outpatient Group)
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Modified Timed Up and Go (mTUG) (Outpatient Group)
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Berg Balance Scale (BBS) (Outpatient Group)
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Device-generated metrics (Number of steps taken)
Time frame: Throughout study completion, for an average of 6 weeks
Device-generated metrics (Level of assistance provided)
Time frame: Throughout study completion, for an average of 6 weeks
Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD
CONTACT
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