Xo-Motion R Exoskeleton in SCI-Adoption Study

NCT07380516 | Not Yet Recruiting

• 1 other identifier: Pro00159509
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

exoskeleton; rehabilitation; locomotion; SCI

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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 Outcomes (4)

• 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)

  At 6 weeks

Study Arms (2)

Inpatient SCI Group

OTHER

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

Outpatient SCI Group

OTHER

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

Interventions

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,

Inpatient SCI Group; Outpatient SCI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• SCI AIS A

Sponsors & Collaborators

• University of Alberta: lead
• Praxis Spinal Cord Institute: collaborator

Study Sites (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G0B7, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jessica M D'Amico, PhD

  University of Alberta and Alberta Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD

CONTACT

780-203-9478; damico1@ualberta.ca

Yoshino Okuma, Clinical Research Specialist, BScRN, MSc

CONTACT

yokuma@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)