The Effect of Vibrotactile Feedback on Exoskeleton Use in People With Motor Complete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Walking distance covered
研究概览
简要总结
This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI.
详细描述
Rationale: People with motor-complete spinal cord injury (SCI) lack motor function below the lesion level and are, thus, wheelchair-dependent. In recent years, wearable exoskeletons have emerged as potential mobility devices for this population. Although exoskeletons generate the basic motions for ambulation, postural stability must be maintained by the user. People with motor-complete SCI miss essential somatosensory perception, which affects their ability to maintain postural stability. Hence, walking in an exoskeleton is demanding, and crutches are necessary.
When sensory information of a specific system is lost, the lack of sensory information can be substituted by providing feedback to another sensory system. As sensory feedback has been shown to improve postural control in people missing essential sensory information, such sensory substitution may also be effectively incorporated in people with complete SCI using an exoskeleton.
Objective
The study aims to investigate the effect of vibrotactile feedback on exoskeleton use in people with motor-complete SCI.
Study design: The proposed study is an experimental study. The study protocol includes six sessions of 90 minutes spread over three weeks. Sessions one to five are dedicated to training to assess the effect of vibrotactile feedback on exoskeleton motor learning. Session six is dedicated to evaluation to assess the effect of vibrotactile feedback on exoskeleton motor control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •SCI classification American Spinal Injury Association Impairment Scale (AIS) A or B
- •Minimally six months post-injury
- •Prior experience with the ReWalk Exoskeleton, able to walk independently
排除标准
- •Pre-existing somatosensory problems before the SCI
- •Visual or auditory issues that are not resolved with glasses or a hearing device
- •Insufficient mastery of the Dutch language
- •Contraindications related to the ABLE Exoskeleton
结局指标
主要结局
Walking distance covered
时间窗: Up to 3 weeks
Walking distance covered during a 50-second walking trial.
次要结局
- User experience questionnaire(After 3 weeks)
- Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) - only including the eight items related to user satisfaction with the assistive device(After 3 weeks)
- Reach path ratio(Up to 3 weeks)
- Reach time(Up to 3 weeks)