Xo-Motion R Exoskeleton in SCI-Adoption Study

ConditionSpinal Cord Injury

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Alberta

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

SCI AIS A

Trial design

Design model

Single group

Treatments tested in this trial

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,

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: Inpatient SCI GroupOther 1 intervention

Group B: Outpatient SCI GroupOther 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

Functional Independence Measure (FIM)

Time frame

Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR

SCIM III

Time frame

Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR

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.

Time frame

At 6 weeks

Participant Structured Interview

Structured interview to accurately capture the participants overall experience and impressions with the exoskeleton.

Time frame

At 6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Praxis Spinal Cord Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: