StrokeNCT02587585
The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
A study testing Feedback against tailored target and No feedback in people with Stroke, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Feedback against tailored target and No feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Admission for second stroke.
- Subjects who are unable to provide consent due to a cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Zhidao Xia, Dr contact
China1 site, 1 recruiting
- Recruiting
The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
Hefei, Anhui
Yun Dong, Dr, +86 551 6266 5048, dongyun1003@126.com
About this study
Official title: 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.
Read the 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
- Stroke
- Being tested
- Feedback against tailored target, No feedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback against tailored targetBehavioural
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 feedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: No feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
Measured: 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
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.
Measured: 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.
Measured: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
Fatigue
Fatigue Severity Index
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
Change in arm function recovery
Grip dynamometer
Measured: 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.
Measured: 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
Measured: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
Adverse events
Self-reported adverse events
Measured: At three weeks, or discharge if sooner and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised, parallel group, single-blinded, attention and feedback controlled study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University, Oxford International Rehabilitation Foundation and Innovation, University of Warwick
- Responsible party
- Principal investigator, Dr Derick Wade, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Investigators
- Derick T Wade, MD, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587585
- Sponsor's protocol ID
- ChiECRCT-20150034
- Status last verified
- Mar 2017
- First submitted
- 30 Sep 2015
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan
Publications
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.
PubMed 30323946Dong 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.
PubMed 29523170
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Randomized Clinical Trial of Activity Feedback During In-patient Stroke Rehabilitation Enabled by Smart Watches
- ClinicalTrials.gov ID
- NCT02587585
- Acronym / sponsor ID
- ChiECRCT-20150034
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Oxford Brookes University, Oxford International Rehabilitation Foundation and Innovation, University of Warwick
- Study start
- Sep 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised, parallel group, single-blinded, attention and feedback controlled study
| Arm | Type | Receives |
|---|---|---|
| Feedback against tailored target | Experimental | Behavioral: Feedback against tailored targetFor 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 | Sham comparator | Behavioral: No feedbackFor 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Admission for second stroke.
- Subjects who are unable to provide consent due to a cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback against tailored targetParticipants 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. | Behavioural | Feedback against tailored target |
| No feedbackParticipants 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. | Behavioural | No Feedback |
Primary outcome
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
10 secondary outcomes
Activity goal attainment as measured and provided by the smart watch
Time frame: At three weeks, or discharge if sooner
Change in walking mobility
Time frame: 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
Health status on EQ-5D-5L
Time frame: 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)
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
Change in arm function recovery
Time frame: 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
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
Adverse events
Time frame: At three weeks, or discharge if sooner and at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 30323946Lawrie 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.
- Derived from this study: PubMed 29523170Dong 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.
- Individual participant dataSharing planned: Undecided. In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhidao Xia, Dr contact
Derick T Wade, MD principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback against tailored target and No feedback in people with Stroke, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Dong, Dr (+86 551 6266 5048, dongyun1003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587585, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.