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

Recruiting

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Feedback of daily activity Behavioral
    Intervention Desc: Participants will wear a smart watch every weekday during in-patient rehabilitation to monitor activity levels while receiving their usual care. Augmented feedback will be provided by the smart watch
    ARM 1: Kind: Experimental
    Label: Activity Feedback
    Description: Feedback
  • Feedback against tailored target Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Feedback against tailored target
    Description: 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.
  • No feedback Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: No Feedback
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 discharge from in-patient rehabilitation (3 weeks) No
Secondary Activity goal attainment as measured and provided by the smart watch Baseline, Three Weeks or discharge from in-patient rehabilitation (3 weeks) No
Secondary Change in walking mobility Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Barrier to physical activity Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Change in Health-Related Quality of Life as measured using the EQ-5D-3L Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Change in functional mobility as measured by Rivermead Mobility Index Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Change in cognitive function as measured by The Montreal Cognitive Assessment Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Change in arm function recovery Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Change in performance of activities of daily living as measured by Barthel Index Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Change in disability as measured by WHODAS Baseline, Three weeks or discharge from in-patient rehabilitation (3 weeks), 3 and 6 months follow-up No
Secondary Fatigue Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
Secondary Health status on EQ-5D-5L Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
Secondary Change in functional mobility as measured by Rivermead Mobility Index (RMI) Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
Secondary Change in cognitive function as measured by The Montreal Cognitive Assessment (MoCA) Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
Secondary Change in performance of activities of daily living as measured by Barthel ADL Index Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
Secondary Change in disability as measured by WHO Disability Assessment Scale (12 item version) Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
Secondary Adverse events At three weeks, or discharge if sooner and at 12 weeks

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