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

NCT ID: NCT02587585

Last Updated: 2017-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-08-31

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomised, parallel group, single-blinded, attention and feedback controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The patients wear identical watches; one gives no feedback on activity levels and one gives feedback on a two-hourly basis, with progress against a target derived from activity 24 hours earlier.

Study Groups

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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.

Group Type EXPERIMENTAL

Feedback against tailored target

Intervention Type BEHAVIORAL

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.

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.

Group Type SHAM_COMPARATOR

No feedback

Intervention Type BEHAVIORAL

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.

Interventions

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Feedback against tailored target

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.

Intervention Type BEHAVIORAL

No feedback

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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford Brookes University

OTHER

Sponsor Role collaborator

Oxford International Rehabilitation Foundation and Innovation

UNKNOWN

Sponsor Role collaborator

University of Warwick

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Dr Derick Wade

Professor in Neurological Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derick T Wade, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford Brookes University

Locations

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The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yun Dong, Dr

Role: CONTACT

+86 551 6266 5048

Zhidao Xia, Dr

Role: CONTACT

Facility Contacts

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Yun Dong, Dr

Role: primary

+86 551 6266 5048

References

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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.

Reference Type DERIVED
PMID: 30323946 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29523170 (View on PubMed)

Other Identifiers

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ChiECRCT-20150034

Identifier Type: -

Identifier Source: org_study_id

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