Evaluation of a Power Assistance Device for Wheelchair-DUO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- ESAT questionnaire
研究概览
简要总结
Power assisted wheelchairs have specific advantages compared to manual propelled or powered Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair can be helped by the device as people propelling the wheelchair with their arms.
Furthermore DUO has an option with a longer assistance (AEP+) which can be preferred by some people.
To be referenced and reimbursed by the French health insurance, DUO has to be compared with an other power assistance device for wheelchairs, already referenced.
The study is a comparative study between DUO and the ALBER E Motion. Each patient is his own control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually propelled, with the E mtion device, with the DUO device and the single push configuration, with the DUO device and the AEP+ configuration.
The main outcome measure will be the user's satisfaction (using 8 items of the ESAT questionnaire)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •with a motor deficiency (of any origin) needing a manual wheelchair
- •propelling his wheelchair with both arms or with one foot and one arm.
- •covered by the French national health insurance.
- •living at less than 30km form the investigation center
排除标准
- •subject of a guardianship or tutelage measure
- •owning already a power wheelchair or a powered assisted wheelchair
- •with cognitive impairments that affect the steering capacity or the understanding of the instructions.
- •Patient unable to use a manual wheelchair indoor without help,
- •Contraindication in keeping a seating position especially the occurrence of ulcers.
结局指标
主要结局
ESAT questionnaire
时间窗: at 12 days
User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire
次要结局
- Success rate during the indoor test (wheelchair skill program)(at 12 days)
- Time run(at 12 days)
- Time to perform the wheelchair skill program(at 12 days)
- Maximal heart rate(at 12 days)
- Effort assessment by the Borg scale(at 12 days)