An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Box and Blocks Test (BBT)
研究概览
简要总结
The goal of this study is to determine the effectiveness of interactive feedback from a wearable device that senses hand function, the Manumeter, in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients
详细描述
In this randomized controlled trial, the investigators will compare two groups of chronic stroke participants Group 1 of study participants will use the Manumeter with interactive functions to monitor and motivate upper extremity functional activity. Group 2 of study participants will use the Manumeter but receive no feedback and will be given the current standard-of-care, a booklet describing a home exercise program for increasing upper extremity exercise. The investigators hypothesize that study participants who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •Experienced one or multiple strokes at least six months previously
- •Upper Extremity Fugl-Meyer Score < 60 out of 66
- •Absence of moderate to severe upper limb pain (< 3 on the a 10 point visual-analog pain scale)
- •Ability to understand the instructions to operate the device
排除标准
- •80 years of age and above
- •Implanted pacemaker
- •moderate to severe pain in affected arm
- •severe tone in affected arm as measured on a standard clinical scale
- •language problem that would prevent from properly understanding instructions
- •currently pregnant
- •difficulty in understanding or complying with the instructions given by the experimenter
- •inability to perform the experimental task that will be studied
研究组 & 干预措施
Manumeter with interactive feedback
Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities.
干预措施: Manumeter (Device)
Manumeter without interactive feedback
Study participants will receive an experimental manumeter but receive no feedback from the manumeter, and will be given the current standard-of-care for increasing upper extremity exercise booklet to perform at home.
干预措施: Manumeter (Device)
结局指标
主要结局
Box and Blocks Test (BBT)
时间窗: 3 months
To measure unilateral gross manual dexterity
次要结局
- Fugl-Meyer Motor Assessment (FM)(3 months)
- Amount of upper extremity activity(3 months)
- Motor Activity Log (MAL)(3 months)
- Action Research Arm Test (ARAT)(3 months)
研究者
David Reinkensmeyer
Professor
University of California, Irvine