Spinal Cord Injury
Conditions
Keywords
exoskeleton, rehabilitation, locomotion, SCI
Brief summary
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.
Interventions
DEVICEXoMotionR- assisted locomotor training
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,
Sponsors
University of Alberta
Praxis Spinal Cord Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* SCI (AIS C or D in inpatient setting, AIS B-D in outpatient setting; inclusive of cervical injuries) * inpatients who are preambulatory with predicted probability of walking independently 1year after injury \>50% (Hicks et al., 2017) * outpatients with a functional goal of improved locomotion where the XoMotion is clinically suited to support the achievement of their functional goals
Exclusion criteria
* SCI AIS A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCI Standing and Walking Assessment (SWAT) | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR | The SWAT will be the primary effectiveness outcome for the inpatient group. |
| 6min Walk Test (6MT) (Outpatient group) | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR | — |
| 10-m Walk Test (10MWT) (Outpatient Group) | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR | — |
| Modified Timed Up and Go (mTUG) (Outpatient Group) | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR | — |
| Berg Balance Scale (BBS) (Outpatient Group) | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR | — |
Secondary
| Measure | Time frame |
|---|---|
| Device-generated metrics (Number of steps taken) | Throughout study completion, for an average of 6 weeks |
| Device-generated metrics (Level of assistance provided) | Throughout study completion, for an average of 6 weeks |
Countries
Canada
Contacts
CONTACTJessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD
CONTACTYoshino Okuma, Clinical Research Specialist, BScRN, MSc
PRINCIPAL_INVESTIGATORJessica M D'Amico, PhD
University of Alberta and Alberta Health Services
Outcome results
None listed