Sensor Enhanced Activity Motivation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Variability Measurement
研究概览
简要总结
The goal of this study is to determine the effectiveness of behavioral support and feedback from a wearable device that senses arm movement 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 evaluate two telerehabilitation strategies for increasing arm use at home: a smartwatch app and a psychological intervention. The psychological intervention aims to address ambivalence and enhance motivation, while the smartwatch provides feedback on arm movement variability. The investigators hypothesize that combining the psychological intervention with smartwatch feedback will lead to greater improvements in arm use and upper extremity recovery
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)
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years of age
- •Experienced a single or multiple, ischemic or hemorrhagic stroke, with unilateral weakness, over six months previously
- •An ability to score at least 3 blocks on the Box and Block Test. BBT score of the affected arm is at least 5% worse than that present with the unaffected arm.
- •Absence of major depression, as defined by DSM V criteria or a score on the Geriatric Depression Scale < 10.
排除标准
- •Any substantial decrease in alertness, language reception, or attention
- •Single or multiple, ischemic or hemorrhagic stroke less than 6 months ago
- •Severe muscle tone at the upper extremity (score ≥ 3 on the Modified Ashworth Spasticity scale)
- •Pregnant or lactating
- •Advanced liver, kidney, cardiac, or pulmonary disease
- •Coexistent major neurological disease
- •Coexistent major psychiatric disease
- •Plans to alter any current participation in other rehabilitation therapy in the time period of the study
- •A terminal medical diagnosis consistent with survival < 1 year
- •A history of significant alcohol or drug abuse in the prior 3 years
- •Current enrollment in another study related to stroke or stroke recovery
- •Any other medical contraindication to participation in the study, as evaluated by our team physician.
- •Visual Analog of Pain Scale Score of 7 or greater
结局指标
主要结局
Variability Measurement
时间窗: From enrollment to the end of treatment and follow up measurement (9 weeks)
The amount of variability for the impaired upper extremity will be quantified by the variety of movements performed.
次要结局
- Active Time(From enrollment to the end of treatment and follow up measurement (9 weeks))
- Fugl-Meyer Arm Motor Assessment(Initial Visit, First follow up, Second follow up)
- Box and Blocks Test(Initial Visit, First follow up, second follow up)
- Nine Hole Peg Test(Initial Visit, First follow up, Second follow up)
- Motor Activity Log (MAL)(Initial Visit, First follow up, Second follow up)
- Open Point(Initial Visit, First follow up, Second follow up)
- NIH Stroke Scale(Initial Visit, First follow up, Second follow up)
- Fatigue Severity Scale (FSS)(Initial Visit, First follow up, Second follow up)
- Fugl-Meyer Sensory Assessment: Touch and Proprioception(Initial Visit, First follow up, Second follow up)
- Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation(Initial Visit, First follow up, Second follow up)
研究者
David Reinkensmeyer
Professor
University of California, Irvine