NCT05977270已完成不适用
Evaluation of the Effects of Lifebloom One on Physical Activity After Acquired Brain Injury: A Single-Case Experimental Study
Lifebloom2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Assessment of daily time spent standing change
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of Lifebloom One in people who have suffered a stroke or a traumatic brain injury.
The main questions to be answered are:
- Does Lifebloom One allow users to spend more time standing each day?
- Does Lifebloom One allow users to improve their balance and gait?
Participants will use Lifebloom One during 8 weeks.
For each participant, gait and balance are compared either with and without Oxilio or before and after Lifebloom One intervention.
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
- •Stroke or traumatic brain injury more than 2 months old
- •Unable to walk without assistance
- •Expected length of stay equal to or greater than 4 months
排除标准
- •Anthropometric incompatibility with Oxilio
- •Unable to walk prior to brain injury
- •No functional upper limb
- •Complete sensory deficit in the lower limb(s)
- •Degenerative impairment (tumor, neurodegenerative disease, etc.)
结局指标
主要结局
Assessment of daily time spent standing change
时间窗: Change from baseline to intervention phase
次要结局
- 10 meter walk test change(Change from baseline to intervention phase)
- Berg Balance Scale change(Change from baseline to intervention phase)
- Psychosocial Impact of Assistive Device Scale (F-PIADS)(at immediate post-intervention)
- Barthel Index (BI)(Before baseline, twice during the intervention phase, at immediate post-intervention)
- Stroke Specific Quality of Life Scale(Before baseline, at immediate post-intervention)
- Patient Health Questionnaire - 9(Before baseline, at immediate post-intervention)
- Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)(at immediate post-intervention)
- Fatigue Severity Scale change(Change from baseline to intervention phase)
- Functional Ambulation Categories (FAC) change(Change from baseline to intervention phase)
- 6 minutes walk test(From the beginning and until the end of the intervention phase (during 8 weeks, one time per week))
研究者
研究点 (2)
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