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

Yun Dong, Dax Steins, Shanbin Sun, Fei Li, James D Amor, Christopher J James, Zhidao Xia, Helen Dawes, Hooshang Izadi, Yi Cao, Derick T Wade, Smart watch activity feedback trial committee (SWAFT), Yuanfeng Peng, Jingjing Xue, Xiaoli Guo, Xuesong Xie, Na Zuo, Xinkui Gao, Lingzhi Wu, Peifang Li, Ying Wang, Chong Chen, Peiyang Sun, Jinji Wang, Feifei Wang, Panfu Hao, Weiwei Wu, Yubao Gao, Xiaoli Sun, Haiyang Wu, Yujie Yang, Yun Dong, Dax Steins, Shanbin Sun, Fei Li, James D Amor, Christopher J James, Zhidao Xia, Helen Dawes, Hooshang Izadi, Yi Cao, Derick T Wade, Smart watch activity feedback trial committee (SWAFT), Yuanfeng Peng, Jingjing Xue, Xiaoli Guo, Xuesong Xie, Na Zuo, Xinkui Gao, Lingzhi Wu, Peifang Li, Ying Wang, Chong Chen, Peiyang Sun, Jinji Wang, Feifei Wang, Panfu Hao, Weiwei Wu, Yubao Gao, Xiaoli Sun, Haiyang Wu, Yujie Yang

Abstract

Background: Practicing activities improves recovery after stroke, but many people in hospital do little activity. Feedback on activity using an accelerometer is a potential method to increase activity in hospital inpatients. This study's goal is to investigate the effect of feedback, enabled by a Smart watch, on daily physical activity levels during inpatient stroke rehabilitation and the short-term effects on simple functional activities, primarily mobility.

Methods/design: A randomized controlled trial will be undertaken within the stroke rehabilitation wards of the Second Affiliated hospital of Anhui University of Traditional Chinese Medicine, Hefei, China. The study participants will be stroke survivors who meet inclusion criteria for the study, primarily: able to participate, no more than 4 months after stroke and walking independently before stroke. Participants will all receive standard local rehabilitation and will be randomly assigned either to receive regular feedback about activity levels, relative to a daily goal tailored by the smart watch over five time periods throughout a working day, or to no feedback, but still wearing the Smart watch. The intervention will last up to 3 weeks, ending sooner if discharged. The data to be collected in all participants include measures of daily activity (Smart watch measure); mobility (Rivermead Mobility Index and 10-metre walking time); independence in personal care (Barthel Activities of Daily Living (ADL) Index); overall activities (the World Health Organization (WHO) Disability Assessment Scale, 12-item version); and quality of life (the Euro-Qol 5L5D). Data will be collected by assessors blinded to allocation of the intervention at baseline, 3 weeks or at discharge (whichever is the sooner); and a reduced data set will be collected at 12 weeks by telephone interview. The primary outcome will be change in daily accelerometer activity scores. Secondary outcomes are compliance and adherence to wearing the watch, and changes in mobility, independence in personal care activities, and health-related quality of life.

Discussion: This project is being implemented in a large city hospital with limited resources and limited research experience. There has been a pilot feasibility study using the Smart watch, which highlighted some areas needing change and these are incorporated in this protocol.

Trial registration: ClinicalTrials.gov, NCT02587585 . Registered on 30 September 2015. Chinese Clinical Trial Registry, ChiCTR-IOR-15007179 . Registered on 8 August 2015.

Keywords: Feedback; Goal setting; Physical activity; Stroke; Technology.

Conflict of interest statement

Ethics approval and consent to participate

Chinese ethics committee (ChiECRCT-20150034)

Registered at clinical trials.gov (NCT02587585) on 30 September 2015

Informed consent will be obtained from all participants before involvement in the study.

Consent for publication

Not applicable.

Competing interests

The smart watch software was developed by the Warwick University research unit (James and Amor) and is in the process of being commercialized by the university. All authors declare that there are no other competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT)-style flow diagram
Fig. 2
Fig. 2
The watch face: blue clock icon showing current 2-hour window and red-green bars showing activity feedback (one group only)
Fig. 3
Fig. 3
Progression of activity completion (top row) and time epoch (below) on the watch face. Note, only the intervention group will see activity feedback
Fig. 4
Fig. 4
Standard protocol items: recommendation for interventional trials (SPIRIT) figure of study timing and activities. ADL, activities of daily living; WHO, World Health Organization

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Source: PubMed

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