XoMotion-R Exoskeleton for Spinal Cord Injury

YO
JM
Overseen ByJessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

JM

Jessica M D'Amico, PhD

Principal Investigator

University of Alberta and Alberta Health Services

Are You a Good Fit for This Trial?

This trial is for individuals with a Spinal Cord Injury (SCI) who have an American Spinal Injury Association Impairment Scale rating of B-D. It's aimed at those wanting to improve walking abilities and are either inpatient or outpatient participants willing to use the XoMotion-R exoskeleton during rehabilitation.

Inclusion Criteria

I am currently hospitalized and expected to walk on my own within a year.
I need the XoMotion device to help me walk better.
I have a spinal cord injury classified as AIS C or D if hospitalized, or AIS B-D if not.

Exclusion Criteria

SCI AIS A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Treatment

Inpatient participants receive locomotor therapy with the XoMotion-R for 30-45 minutes, 2-3 times per week, focusing on early weight-bearing and postural control

6 weeks
2-3 visits per week (in-person)

Outpatient Treatment

Outpatient participants receive locomotor therapy with the XoMotion-R for 30-45 minutes, 2-3 times per week, focusing on increased walking distance and community-based ambulation

6 weeks
2-3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • XoMotionR

Trial Overview

The study tests the XoMotion-R, a self-balancing exoskeleton designed for hands-free walking by people with certain levels of SCI. The goal is to see if it can help improve their ability to walk and reduce hospital stay, complications, and long-term disability.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Outpatient SCI GroupExperimental Treatment1 Intervention
Group II: Inpatient SCI GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Praxis Spinal Cord Institute

Collaborator

Trials
5
Recruited
80+