An interventional study of Feedback against tailored target and No feedback in Stroke, sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-21.
Sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 200 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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. 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.
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.
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
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.
Time frame: 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.
Time frame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
Fatigue
Fatigue Severity Index
Time frame: 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
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)
This scale assesses functional mobility in gait, balance and transfers after stroke
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)
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.
Time frame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
Change in arm function recovery
Grip dynamometer
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
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.
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)
This scale provides a global measure of disability covering 6 domains: cognition, mobility, self-care, getting along, life activities, and participation
Time frame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
Adverse events
Self-reported adverse events
Time frame: At three weeks, or discharge if sooner and at 12 weeks
Plan to share: Undecided — In the unlikely event that someone asks, it will probably be shared but so far (March 2017) there is no plan
The record gives a start of Sep 2015, a primary completion of Jan 2018 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine