Study design and participants
post-stroke, spasticity, cognitive impairment, chronic stroke, stroke, peripheral polyneuropathy, dementia, neurological diseases, aphasia
STROKE, NEUROLOGICAL DISEASE
This study was a single-blinded, randomized controlled trial to investigate whether using mirror therapy as a priming strategy would augment therapeutic effects of robot-assisted therapy on motor function, daily function, and self-efficacy in chronic stroke survivors (ClinicalTrials.gov Identifier: NCT03917511, registered on 17/04/2019). The institutional review boards of Chang Gung Memorial Hospital approved the trials (IRB No. 201801025B0C603), and all participants provided written informed consent before participating. All methods were performed in accordance with relevant guidelines and regulations. The sample size of this study was estimated based on the systematic review and meta-analysis of robot-assisted therapy on upper limb recovery after stroke, which showed medium to large effect sizes measured by Fugl-Meyer AssessmentParticipants were recruited from medical centers in Taiwan, who attended for post-stroke rehabilitation between December 2018 and April 2021. The inclusion criteria included: (1) unilateral stroke ≥ 3 months prior to study enrollment; (2) Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score < 60; (3) without excessive spasticity in any of the UE joint (modified Ashworth scale ≤ 3); (4) Mini Mental State Exam (MMSE) score > 24, indicating no serious cognitive impairment; and (5) between the ages of 20 and 75 years. The exclusion criteria included: (1) histories of other neurological diseases such as dementia and peripheral polyneuropathy; (2) difficulties in following and understanding instructions such as global aphasia; (3) enroll in other rehabilitation or drug studies simultaneously; (4) receiving Botulinum toxin injections within 3 months. The research design and flow process are shown in Fig. Flow diagram illustrating the flow of participants through each stage of the study.