Xo-Motion R Exoskeleton in SCI-Adoption Study

Official title

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

Overview

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.

Interventions

• 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 trans

Primary outcome measures

• SCI Standing and Walking Assessment (SWAT) [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]
• Berg Balance Scale (BBS) (Outpatient Group) [Time frame: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR]

Secondary outcome measures (2)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Glenrose Rehabilitation Hospital — Edmonton

Identifiers

NCT: NCT07380516 · Pro00159509

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗