NCT02587585

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

April 21, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

September 30, 2015

Last Update Submit

April 20, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Activity goal attainment as measured and provided by the smart watch

    At three weeks, or discharge if sooner

  • Change in walking mobility

    Baseline, Three weeks or discharge from in-patient rehabilitation if sooner

  • Fatigue

    Baseline, Three weeks or discharge from in-patient rehabilitation if sooner

  • Health status on EQ-5D-5L

    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)

    Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)

  • +5 more secondary outcomes

Study Arms (2)

Feedback against tailored target

EXPERIMENTAL

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

No Feedback

SHAM COMPARATOR

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

Interventions

Feedback against tailored targetBEHAVIORAL

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.

Feedback against tailored target
No feedbackBEHAVIORAL

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.

No Feedback

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Admission for second stroke.
  • Subjects who are unable to provide consent due to a cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hefei, Anhui, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30323946DERIVED

  • 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.

    PMID: 29523170DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Derick T Wade, MD

    Oxford Brookes University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Dong, Dr

CONTACT

+86 551 6266 5048dongyun1003@126.com

Zhidao Xia, Dr

CONTACT

zhidao.xia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised, parallel group, single-blinded, attention and feedback controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Neurological Rehabilitation

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 27, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2018

Study Completion

August 1, 2018

Last Updated

April 21, 2017

Record last verified: 2017-03

Locations

CN(1)