跳至主要内容
临床试验/NCT07380516
NCT07380516尚未招募不适用

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

University of Alberta1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2027年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
试验地点
1
主要终点
SCI Standing and Walking Assessment (SWAT)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • SCI AIS A

研究组 & 干预措施

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.

干预措施: XoMotionR- assisted locomotor training (Device)

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.

干预措施: XoMotionR- assisted locomotor training (Device)

结局指标

主要结局

SCI Standing and Walking Assessment (SWAT)

时间窗: 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)

时间窗: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR

10-m Walk Test (10MWT) (Outpatient Group)

时间窗: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR

Modified Timed Up and Go (mTUG) (Outpatient Group)

时间窗: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR

Berg Balance Scale (BBS) (Outpatient Group)

时间窗: Baseline and completion of 6 weeks of locomotor therapy with the XoMotionR

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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