An International Randomized Clinical Trial of Activity Feedback During In-patient Stroke Rehabilitation Enabled by Smart Watches
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Feedback against tailored target (Behavioral)
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.
Intervention: No feedback (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in disability as measured by WHO Disability Assessment Scale (12 item version)(Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks)
- Change in walking mobility(Baseline, Three weeks or discharge from in-patient rehabilitation if sooner)
- Change in arm function recovery(Baseline, Three weeks or discharge from in-patient rehabilitation if sooner)
- 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))
- Adverse events(At three weeks, or discharge if sooner and at 12 weeks)
- Change in cognitive function as measured by The Montreal Cognitive Assessment (MoCA)(Baseline, Three weeks or discharge from in-patient rehabilitation if sooner)
- Activity goal attainment as measured and provided by the smart watch(At three weeks, or discharge 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 performance of activities of daily living as measured by Barthel ADL Index(Baseline, Three weeks or discharge from in-patient rehabilitation if sooner)
Investigators
Dr Derick Wade
Professor in Neurological Rehabilitation
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine