Clinical trial NCT02587585: The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation
Official title: An International Randomized Clinical Trial of Activity Feedback During In-patient Stroke Rehabilitation Enabled by Smart Watches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Oxford Brookes University
name: Oxford International Rehabilitation Foundation and Innovation
name: University of Warwick
First posted: 2015-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, parallel group, single-blinded, attention and feedback controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in activity counts as measured by a triaxial accelerometer from a smart watch from admission to 3 weeks or discharge from rehabilitation
timeFrame: Baseline, Three weeks or at discharge from in-patient rehabilitation if sooner
Secondary outcomes:
measure: Activity goal attainment as measured and provided by the smart watch
timeFrame: At three weeks, or discharge if sooner
measure: Change in walking mobility
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
measure: Fatigue
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
measure: Health status on EQ-5D-5L
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
measure: Change in functional mobility as measured by Rivermead Mobility Index (RMI)
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks (by telephone)
measure: Change in cognitive function as measured by The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
measure: Change in arm function recovery
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
measure: Change in performance of activities of daily living as measured by Barthel ADL Index
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner
measure: Change in disability as measured by WHO Disability Assessment Scale (12 item version)
timeFrame: Baseline, Three weeks or discharge from in-patient rehabilitation if sooner, and 12 weeks
measure: Adverse events
timeFrame: At three weeks, or discharge if sooner and at 12 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The 2nd Affiliated Hospital to Anhui University of Tranditional Chinese Medicine
state: Anhui
Study officials:
affiliation: Oxford Brookes University
name: Derick T Wade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.