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NCT07380516
Xo-Motion R Exoskeleton in SCI-Adoption Study
Conditions: Spinal Cord Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: University of Alberta
Location: Glenrose Rehabilitation Hospital Edmonton Alberta
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07380516). StuddyBuddy aggregates publicly available trial information.