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| Name | Class |
|---|---|
| Praxis Spinal Cord Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient SCI Group | Other | During their inpatient rehabilitation, the XoMotionR will be incorporated into their locomotor therapy program for approximately 30-45minutes, 2-3 times per week, up to 6 weeks. 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. |
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| Outpatient SCI Group | Other | Through our Specialized Outpatient Rehabilitation Program or Research Lab in the Courage Centre, SCI outpatients will be recruited and the XoMotionR will be incorporated into their locomotor therapy program for approximately 30-45minutes, 2-3 times per week, up to 6 weeks. 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, the focus shifts toward higher-level gait tasks, including multi-surface walking, obstacle negotiation, and endurance training. Individuals are encouraged to use assistive devices with progressively less support as their neuromuscular control improves. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XoMotionR- assisted locomotor training | Device | 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, |
| Measure | Description | Time Frame |
|---|---|---|
| SCI Standing and Walking Assessment (SWAT) | The SWAT will be the primary effectiveness outcome for the inpatient group. | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR |
| 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR | |
| SCIM III | Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD | Contact | 780-203-9478 | damico1@ualberta.ca | |
| Yoshino Okuma, Clinical Research Specialist, BScRN, MSc | Contact | yokuma@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jessica M D'Amico, PhD | University of Alberta and Alberta Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenrose Rehabilitation Hospital | Edmonton | Alberta | T5G0B7 | Canada |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| System Usability Scale (SUS) |
The SUS is a standard scale used to evaluate a technology. It will be completed by all clinicians who used the device at the end of the study. |
| At 6 weeks |
| Participant Structured Interview | Structured interview to accurately capture the participants overall experience and impressions with the exoskeleton. | At 6 weeks |
| D014947 | Wounds and Injuries |