Xo-Motion R Exoskeleton in SCI-Adoption Study

Adoption of the Xo-Motion R in the Subacute and Chronic SCI Populations at the Glenrose Rehabilitation Hospital

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: XoMotionR- assisted locomotor training

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD; Phone Number: 780-203-9478; Email: damico1@ualberta.ca
• Study Contact Backup: Name: Yoshino Okuma, Clinical Research Specialist, BScRN, MSc; Email: yokuma@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5G0B7
      • Glenrose Rehabilitation Hospital
      • Principal Investigator: Jessica M D'Amico, PhD
      • Contact: Yoshino Okuma, Clinical Research Specialist, BScRN, MSc; Email: yokuma@ualberta.ca
      • Contact: Jessica M D'Amico, Scientific Program Lead, Assistant Professor, PhD; Phone Number: 780-203-9478; Email: damico1@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inpatient SCI Group; 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.	Device: XoMotionR- assisted locomotor training; 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,
Other: Outpatient SCI Group; 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.	Device: XoMotionR- assisted locomotor training; 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Praxis Spinal Cord Institute
• Investigators: Principal Investigator: Jessica M D'Amico, PhD, University of Alberta and Alberta Health Services

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; SCI; exoskeleton; locomotion
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: Pro00159509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No