Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Motor Activity Log - 14, Amount of Use sub scale
研究概览
简要总结
Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.
The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.
ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
- •Ability to lift arm against gravity (>30 degrees flexion or abduction)
- •Ability to don/doff the devices on both wrists independently or with assistance of a caregiver
- •Ability to give informed consent as documented by signature
排除标准
- •Major untreated depression
- •Severe cognitive impairment
- •Suffering from comprehensive aphasia
- •Severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes)
- •Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.)
- •Expected hospitalization during study period
- •Known intolerance to device material
- •Known or suspected non-compliance, drug or alcohol abuse
- •The investigator, his/her family members, employees, and other dependent persons
结局指标
主要结局
Motor Activity Log - 14, Amount of Use sub scale
时间窗: Post-intervention (6 weeks)
Self-reported amount of upper limb use in daily life
次要结局
- Modified Rankin Scale(Follow-up (12 weeks))
- EuroQol five dimensions five levels questionnaire(Follow-up (12 weeks))
- Action Research Arm Test(Follow-up (12 weeks))
- Motor Activity Log - 14, Quality of Movement sub scale(Follow-up (12 weeks))
- Motor Activity Log - 14, Amount of Use sub scale(Follow-up (12 weeks))
- Fugl-Meyer Assessment, Upper Extremity sub scale(Follow-up (12 weeks))