Abstract
BackgroundUpper limb dysfunction is common after stroke, posing an important challenge for post-stroke rehabilitation. The clinical efficacy of acupuncture for the recovery of post-stroke upper limb function has been previously demonstrated. Mirror therapy (MT) has also been found to be effective. However, the effects of acupuncture and MT have not been systematically compared. This trial aims to elucidate the synergistic effects of acupuncture and MT on upper limb dysfunction after stroke.MethodsA 2 × 2 factorial randomized controlled trial will be conducted at the rehabilitation hospitals affiliated with Fujian University of Traditional Chinese Medicine. A total of 136 eligible subjects will be randomly divided into acupuncture treatment (AT), MT, combined treatment, and control groups in a 1:1:1:1 ratio. All subjects will receive conventional treatment. The interventions will be performed 5 days per week for 4 weeks. AT, MT, and combined treatment will be performed for 30 min per day (combined treatment: AT 15 min + MT 15 min). The primary outcomes in this study will be the mean change in scores on both the FMA and WMFT from baseline to 4 weeks intervention and at 12 weeks follow-up between the two groups and within groups. The secondary outcomes are the mean change in the scores on the Visual Analogue Scale, Stroke Impact Scale, and modified Barthel index. Medical abstraction of adverse events will be assessed at each visit.DiscussionThe results of this trial will demonstrate the synergistic effect of acupuncture and MT on upper limb motor dysfunction after stroke. In addition, whether AT and MT, either combined or alone, are more effective than the conventional treatment in the management of post-stroke upper limb dysfunction will also be determined.Trial registrationChinese Clinical Trial Registry: ChiCTR-IOR-17011118. Registered on April 11, 2017. Version number: 01.2016.09.1.
Highlights
Upper limb dysfunction is common after stroke, posing an important challenge for post-stroke rehabilitation
The incidence of upper limb dysfunction caused by stroke can reach up to 66% [23]
Approximately 70–80% of new patients lose their ability to work to varying degrees and cannot take care of themselves, placing a heavy burden on patients, families, and society [24]
Summary
Study design and setting This trial will use a 2 × 2 factorial randomized controlled study to explore the clinical efficacy of AT combined with MT for improving the upper limb motor function of stroke patients It will be performed in the Rehabilitation Hospitals Affiliated with Fujian University of Traditional Chinese Medicine (FJTCM). During the 6- and 12-week follow-up periods (10 weeks and 16 weeks after intervention), participants will be referred for clinical evaluation to assess their functional status, including upper limb function, quality of life, and ADL. The WMFT is the preferred scale for assessing mandatory exercise therapy for improving upper limb functions It can either assess the quality of the patient’s completion of each activity or determine the time required for the patient to do so. The CRF questionnaire will be submitted to the investigator via the clinical examiner for data auditing, and the investigator should reply as soon as possible thereafter
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