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

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status: Unknown

Conditions: Stroke

Treatments: Behavioral: No feedback; Behavioral: Feedback against tailored target

Study type: Interventional

Funder types: Other

Identifiers

NCT02587585

ChiECRCT-20150034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Feedback against tailored target

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback against tailored target

No Feedback

Sham Comparator group

Description:

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.

Treatment:

Behavioral: No feedback