Patients and interventions
Spasticity, spasticity, cognitive impairment, stroke, apraxia, pain, aphasia, hemorrhage, first‐ever stroke, upper extremity motor function, excessive sensory disturbance, hand hemiplegia, infarct
MULTIPLE ORGAN FAILURE, STROKE, HEMORRHAGE, INFARCT, MALIGNANT DISEASE
This study was a randomized, single‐blind, controlled trial conducted at Huashan Hospital in Shanghai, China. All potential participants were screened by the physicians for eligibility. Each participant signed a written informed consent before participation. This study was approved by the Review Board of Ethics Committee of Huashan Hospital and registered at the Chinese Clinical Trial Registry (ChiCTR‐TRC‐08003005). The study design and protocol are shown in a flow diagram according to CONSORT guidelines (Figure. CONSORT flow diagram of the study designInclusion criteria: (1) first‐ever stroke (infarct or hemorrhage); (2) stroke onset between 3 and 12 months before enrollment for the study; (3) no significant cognitive impairment (Mini‐Mental State Examination ≥ 27); (4) age between 18 and 80 years; (5) unilateral upper limb and hand hemiplegia (Brunnstrom stage ≤ grade IV); and (6) right‐handed before stroke according to the Edinburgh Handedness scale.Exclusion criteria: (1) severe spasticity (Modified Ashworth Spasticity Scale > 2) of the affected upper extremity; (2) significant pain on the affected side (Ten‐point Visual Analog Scale > 4); (3) excessive sensory disturbance, aphasia, neglect, or apraxia; (4) active malignant disease or multiple organ failure; (5) presently enrolled in any other rehabilitation or drug studies.The sample size was calculated before the start of the study using the stepped rules of thumb for pilot trials.All recruited patients were randomly assigned to one of the two groups, that is, the control group (CON group, All patients underwent rehabilitation interventions 5 days a week for 4 weeks. Daily interventions included 3 h of conventional rehabilitation therapy and 30 min of group‐specific treatments; motor imagery training for the MIT group and health education on stroke information or patient–physician consultation for the CON group.All the patients were assessed for upper extremity motor function and activities of daily living by an independent physician blinded to the treatment condition, before and after the 4‐week interventions. The primary outcome measure was the Upper Extremity Fugl‐Meyer score which is a valid and reliable tool for evaluating upper limb motor level within and between raters in stroke survivors,