Spinal Cord InjuryNCT07380516
Xo-Motion R Exoskeleton in SCI-Adoption Study
A study testing XoMotionR- assisted locomotor training in people with Spinal Cord Injury, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- XoMotionR- assisted locomotor training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2027to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- SCI AIS A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD contact
Yoshino Okuma, Clinical Research Specialist, BScRN, MSc contact
Canada1 site
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G0B7
Jessica M D'Amico, Scientific Program Lead, Assistant Professor, PhD, 780-203-9478, damico1@ualberta.ca
Yoshino Okuma, Clinical Research Specialist, BScRN, MSc, yokuma@ualberta.ca
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury
- Being tested
- XoMotionR- assisted locomotor training
- Keywords
- exoskeleton, rehabilitation, locomotion, SCI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XoMotionR- assisted locomotor trainingDevice
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: XoMotionR- assisted locomotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCI Standing and Walking Assessment (SWAT)
The SWAT will be the primary effectiveness outcome for the inpatient group.
Measured: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
6min Walk Test (6MT) (Outpatient group)
Measured: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
10-m Walk Test (10MWT) (Outpatient Group)
Measured: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Modified Timed Up and Go (mTUG) (Outpatient Group)
Measured: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Berg Balance Scale (BBS) (Outpatient Group)
Measured: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
Secondary outcomes (2)
Device-generated metrics (Number of steps taken)
Measured: Throughout study completion, for an average of 6 weeks
Device-generated metrics (Level of assistance provided)
Measured: Throughout study completion, for an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Mar 2027 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Praxis Spinal Cord Institute
- Responsible party
- Sponsor
- Investigators
- Jessica M D'Amico, PhD, Principal investigator, University of Alberta and Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380516
- Sponsor's protocol ID
- Pro00159509
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoption of the Xo-Motion R in the Subacute and Chronic SCI Populations at the Glenrose Rehabilitation Hospital
- ClinicalTrials.gov ID
- NCT07380516
- Acronym / sponsor ID
- Pro00159509
- Conditions
- Spinal Cord Injury
- Keywords
- exoskeleton, rehabilitation, locomotion, SCI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Praxis Spinal Cord Institute
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient SCI Group | Other | Device: XoMotionR- assisted locomotor trainingDuring 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. |
| Outpatient SCI Group | Other | Device: XoMotionR- assisted locomotor trainingThrough 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- SCI AIS A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XoMotionR- assisted locomotor trainingThe 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, | Device | Inpatient SCI Group, Outpatient SCI Group |
Primary outcome
SCI Standing and Walking Assessment (SWAT)
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
The SWAT will be the primary effectiveness outcome for the inpatient group.
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
Berg Balance Scale (BBS) (Outpatient Group)
Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR
2 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD contact
Yoshino Okuma, Clinical Research Specialist, BScRN, MSc contact
Jessica M D'Amico, PhD principal investigator
University of Alberta and Alberta Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XoMotionR- assisted locomotor training in people with Spinal Cord Injury, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica M D'Amico, Scientific Program Lead and Assistant Professor, PhD (780-203-9478, damico1@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCI Standing and Walking Assessment (SWAT) (time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.