"Effectiveness of Lumbar Assistive Exoskeleton in Nursing Home Caregivers: Randomized Control Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change from baseline Pain Intensity at 3 months
研究概览
简要总结
A randomized control trial will be conducted, for evaluating the effectiveness of the implementation of a lower back assistive exoskeleton on the caregivers working in nursing homes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators in charge of doing the statistical analysis and assessing the outcome measures (e.g., physical performance tests) will be blinded to group allocation. Due to the characteristics of the study (use of the exoskeleton during working hours) blinding of the participants is not possible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nursing home caregivers
排除标准
- •pregnancy
- •presence of condition that prevents from the use of a lumbar exoskeleton
结局指标
主要结局
Change from baseline Pain Intensity at 3 months
时间窗: At Baseline and at 3 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
Change from baseline Pain Intensity at 6 months
时间窗: At Baseline and at 6 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
Change from baseline Pain Intensity at 9 months
时间窗: At Baseline and at 9 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
Change from baseline Pain Intensity at 12 months
时间窗: At Baseline and at 12 months
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands
次要结局
- Self-reported work ability by Work Ability Index(Baseline, month 3, month 6, month 9, post intervention)
- Usability measured by System Usability Scale(Baseline, month 3, month 6, month 9, post intervention)
- User Satisfaction measured by Quebec User Evaluation of Satisfaction with Assistive Technology(Baseline, month 3, month 6, month 9, post intervention)
- Absenteeism(Baseline, month 3, month 6, month 9, post intervention)
- Musculoskeletal disorders prevalence(Baseline, month 3, month 6, month 9, post intervention)
- Prevalence of Side Effects(Baseline, month 3, month 6, month 9, post intervention)
- Borg's CR-10 scale for perceived physical exertion at work(Baseline, month 3, month 6, month 9, post intervention)
- Muscular resistance of the trunk muscles measured by the "Shirado-Ito" test(Baseline, month 3, month 6, month 9, post intervention)
- Discomfort measured by Body Part Discomfort Scale(Baseline, month 3, month 6, month 9, post intervention)
研究者
Maialen Aiestaran, MsC
Principal Investigator
University of the Basque Country (UPV/EHU)