NCT Number: NCT07380516
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T5G0B7, Canada
Jessica M D'Amico, PhD
PRINCIPAL_INVESTIGATOR
Jessica M D'Amico, Scientific Program Lead, Assistant Professor, PhD
CONTACT
Yoshino Okuma, Clinical Research Specialist, BScRN, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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,
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
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
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Time frame: Throughout study completion, for an average of 6 weeks
Time frame: Throughout study completion, for an average of 6 weeks
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Time frame: At 6 weeks
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.
Time frame: At 6 weeks
Structured interview to accurately capture the participants overall experience and impressions with the exoskeleton.
Contact information is provided by the study sponsor or research team.
Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD
CONTACT
Yoshino Okuma, Clinical Research Specialist, BScRN, MSc
CONTACT
University of Alberta
Other
Adoption of the Xo-Motion R in the Subacute and Chronic SCI Populations at the Glenrose Rehabilitation Hospital
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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