The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
2017年4月20日 更新者：Dr Derick Wade、The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
An International Randomized Clinical Trial of Activity Feedback During In-patient Stroke Rehabilitation Enabled by Smart Watches
The amount of activity completed by individuals within rehabilitation programs, even when units are well staffed, is often far below that required for optimal stroke rehabilitation, and is not individually adapted on a day-to-day basis.
Daily feedback on their activity levels may motivate stroke survivors to engage in greater skills practice and thus outcome after stroke.
To date only a few trials suggests that augmented feedback may be effective.
There is a need for a large pragmatic trial to explore the impact of augmented activity feedback on top of their standard care.
The purpose of this study is to determine the effect of augmented activity feedback by smart watches to support in-patient stroke rehabilitation.
研究概览
详细说明
This study had a feasibility and pilot development phase from September 2015 to April 2016, and then moved into the main study with some changes in design and execution occurring in the light of experience. Its execution has also been constrained by external factors beyond control.
It is in essence asking whether wearing a Smart Watch which gives feedback on activity every two hours, with a specific target tailored to the patient's performance 24 hours earlier will be associated with a higher rate of physical activity than seen in people wearing the same watch without and feedback been given.
The intervention only lasts unto 21 days, but earlier discharge will terminate that patient's participation sooner. A telephone interview at 12 weeks after entry collect data on mobility.
Outcome measures will assess mobility, activity, and health status.
研究类型
介入性
注册 (预期的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Anhui
-
Hefei、Anhui、中国
- 招聘中
- The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
-
接触：
- Yun Dong, Dr
- 电话号码：+86 551 6266 5048
- 邮箱：dongyun1003@126.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Admission for acute/sub-acute in-patient neurorehabilitation of a first stroke at the 2nd affiliated hospital of Anhui University of Traditional Medicine and Acupuncture, Hefei, China.
- Time from onset of stroke to admission for rehabilitation <16 weeks.
- Ability to follow a two stage command; pick up an object, put object on table.
- Independent in mobility prior to admission. Subjects can use any type of assistive device and brace needed.
- Able to understand and repeat information related to the Informed Consent.
Exclusion Criteria:
- Admission for second stroke.
- Subjects who are unable to provide consent due to a cognitive impairment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Feedback against tailored target
For each two hour epoch, the watch calculate the level of activity for the same epoch the day before, and adds 5% as the new target to be achieved.
|
Participants will wear a smart watch every weekday for nine hours during in-patient rehabilitation to monitor activity levels while receiving their usual care.
In the active group, the watch will summate activity movement in two hour epochs and the target for the day for that epoch is the activity in the same epoch 24 hours earlier, plus 5%.
During an epoch the patient is shown progress towards the target at at the end of an epoch, they will see their final process towards target for that epoch.
|
|
假比较器：No Feedback
For participants assigned to the control group, the smart watch will not provide any activity feedback against a target; it simply shows which two hour epoch a person is in.
|
Participants will wear a smart watch every weekday for nine hours during in-patient rehabilitation to monitor activity levels while receiving their usual care.
However the watch face will simply show which epoch a person is in.
The watch will collect the activity in exactly the same way over the day.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
大体时间：Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
|
Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Activity goal attainment as measured and provided by the smart watch
大体时间：At three weeks, or discharge if sooner
|
Participants in feedback group receive a preset activity goal based on their previous activity levels at baseline.
The smart watch will then provide graduated encouragement by increasing their activity goal by about 5%.
Every 10-15 minutes the screen lights up and participants can see their activity progress expressed by activity bars (representing 0-100%).
Participants reaching their activity goal is used to measure goal attainment.
|
At three weeks, or discharge if sooner
|
|
Change in walking mobility
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
Change in walking speed and spatio-temporal characteristics of walking as measured by an inertial sensor on the lower trunk during a 10m walk test.
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Fatigue
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
Fatigue Severity Index
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Health status on EQ-5D-5L
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
This scale is used a measure for health status and compromises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
|
Change in functional mobility as measured by Rivermead Mobility Index (RMI)
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
This scale assesses functional mobility in gait, balance and transfers after stroke
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
|
|
Change in cognitive function as measured by The Montreal Cognitive Assessment (MoCA)
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
This is a screening instrument for to measure mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Change in arm function recovery
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
Grip dynamometer
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Change in performance of activities of daily living as measured by Barthel ADL Index
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
This scale is used to record what the participant undertakes in personal activities, to establish a degree of independence from any help, physical or verbal.
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
|
|
Change in disability as measured by WHO Disability Assessment Scale (12 item version)
大体时间：Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
|
This scale provides a global measure of disability covering 6 domains: cognition, mobility, self-care, getting along, life activities, and participation
|
Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
|
|
Adverse events
大体时间：At three weeks, or discharge if sooner and at 12 weeks
|
Self-reported adverse events
|
At three weeks, or discharge if sooner and at 12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Derick T Wade, MD、Oxford Brookes University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lawrie S, Dong Y, Steins D, Xia Z, Esser P, Sun S, Li F, Amor JD, James C, Izadi H, Cao Y, Wade D, Mayo N, Dawes H; Smart Watch Activity Feedback Trial Committee (SWAFT). Evaluation of a smartwatch-based intervention providing feedback of daily activity within a research-naive stroke ward: a pilot randomised controlled trial. Pilot Feasibility Stud. 2018 Oct 6;4:157. doi: 10.1186/s40814-018-0345-x. eCollection 2018.
- Dong Y, Steins D, Sun S, Li F, Amor JD, James CJ, Xia Z, Dawes H, Izadi H, Cao Y, Wade DT; Smart watch activity feedback trial committee (SWAFT). Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial. Trials. 2018 Mar 9;19(1):177. doi: 10.1186/s13063-018-2476-z.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (预期的)
2018年1月1日
研究完成 (预期的)
2018年8月1日
研究注册日期
首次提交
2015年9月30日
首先提交符合 QC 标准的
2015年10月23日
首次发布 (估计)
2015年10月27日
研究记录更新
最后更新发布 (实际的)
2017年4月21日
上次提交的符合 QC 标准的更新
2017年4月20日
最后验证
2017年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.