A reminder incentive system promotes the functional recovery of stroke patients with hemiplegia: A large-sample, single-blind, randomized controlled trial

Abstract

Background and objectives: Acupuncture and physical rehabilitation training have been shown to promote recovery in stroke patients with hemiplegia. Many patients are unable to consistently complete rehabilitation training because of a variety of factors. The aim of this study was to investigate the effects of wearing a wrist watch with versus without a rehabilitation training-reminder incentive system on locomotor function in stroke patients with hemiplegia. Participants and methods: This large-sample, single-blind, randomized controlled trial will be performed at the Second Affiliated Hospital of Anhui University of Chinese Medicine, Oxford International Rehabilitation Foundation Limited, and Oxford Brookes University. A total of 200 stroke patients with hemiplegia will be randomly divided into a test group and a control group. The two groups of patients will receive routine medication, acupuncture, and rehabilitation training. Patients in the test group will wear a smart watch with a reminder incentive system that encourages them to complete a set amount of personalized physical exercise tasks, and patients in the control group will wear a watch without a reminder incentive system. This study was approved by the Medical Ethics Committee of the Chinese Clinical Trial Registry on June 16, 2015 (approval No. ChiECRCT-20150034). Study protocol: 1.0. Participants will provide written informed consent. Results: The primary outcome measure of this study is the differences in the Barthel index measured 3 weeks after discharge (i.e., after 6 weeks of treatment). The secondary outcome measures include neurological deficit scores, National Institutes of Health stroke scale score, Rivermead mobility index, Montreal Cognitive Assessment score, blood pressure, body weight, grip strength, Timed Up and Go Test score, exercise level, EuroQol five dimensions questionnaire score, and adverse events before treatment, after 3 weeks of treatment, and 3 weeks after discharge (after 6 weeks of treatment). In a pilot study, 60 stroke patients with hemiplegia received acupuncture and incentive rehabilitation training. The results showed that in stroke patients with hemiplegia who received elongated needle acupuncture at antagonistic muscles combined with muscle balance exercises, Barthel index and Fugl-Meyer Assessment scale scores increased and Modified Ashworth Scale scores decreased compared with those who received elongated needle acupuncture at antagonistic muscles alone. Conclusion: We will perform a study involving 200 stroke patients to evaluate whether stroke patients with hemiplegia who receive acupuncture combined with rehabilitation training while wearing a smart watch with a reminder incentive system exhibit better recovery of locomotor function compared with those who receive similar interventions but are not exposed to a reminder incentive system. These experimental data will support the implementation of functional smart device-assisted rehabilitation medical programs. Trial registration: This study was registered with Chinese Clinical Trial Registry on August 8, 2015 (registration number: ChiCTR-IOR- 15007179).