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

April 20, 2017 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Collaborators

Oxford Brookes University
University of Warwick
Oxford International Rehabilitation Foundation and Innovation

Investigators

  • Principal Investigator: Derick T Wade, MD, Oxford Brookes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChiECRCT-20150034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Feedback against tailored target

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe