The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An International Randomized Clinical Trial of Activity Feedback During In-patient Stroke Rehabilitation Enabled by Smart Watches

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Feedback against tailored target
* Behavioral: No feedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised, parallel group, single-blinded, attention and feedback controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback against tailored target<br>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. | Behavioral: Feedback against tailored target<br>* 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.<br>|
| Sham Comparator: No Feedback<br>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. | Behavioral: No feedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation |  | Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity goal attainment as measured and provided by the smart watch | 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 | 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 | Fatigue Severity Index | Baseline, Three weeks or discharge from in-patient rehabilitation if sooner | 
| Health status on EQ-5D-5L | 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) | 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) | 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 | 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 | 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) | 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 | Self-reported adverse events | At three weeks, or discharge if sooner and at 12 weeks |