Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol

Abstract Background Many therapeutic interventions are performed by physiotherapists to improve upper extremity function and/or activities of daily living (ADL) in stroke patients. Mirror therapy (MT) is a simple technique that can be self-administered by the patients with intact cognition following patient education by a skilled physiotherapist. However, the effectiveness of self-administered MT in post-stroke patients in upper extremity function remains unclear. Therefore, the objective of this study is to examine the effectiveness of MT in improving upper extremity function and recovery in acute stroke patients. Methods This study is a single-center, prospective, randomized, open-label, controlled trial with blinded outcome evaluation (PROBE design), in which a total of 36 eligible acute stroke patients will be randomly assigned to control (n=18) and experimental group (n=18). Participants in the control group will receive regular rehabilitation interventions whereas participants in the experimental group will receive MT education in addition to their regular interventions for 4 weeks. Study outcome The primary outcome measure will be upper extremity function that will be measured using the Fugl-Meyer Assessment scale and the Wolf Motor Function Test. The secondary outcome measure will be behaviors related to ADL as estimated using the Modified Barthel Index. Outcome measures will be assessed at baseline and at 4 weeks post-rehabilitation intervention/MT. Results A two-way repeated analysis of variance (ANOVA) with time and group effects will be used to analyze between-group differences. The level of significance will be set at P < 0.05. Conclusion The results of the study will provide critical information to include self-administered MT as an adjuvant to regular interventions and may facilitate recovery of the upper extremity function of stroke patients. Trial registration ClinicalTrials.gov NCT04542772 . Registered on 9 September 2020. Protocol version: Final 1.0