Measuring the Potential Effects of Mirror Therapy Added to the Gold Standard Facial Neuromuscular Retraining in Patients With Chronic Peripheral Facial Palsy: Protocol for a Randomized Controlled Trial

Abstract

Background Facial neuromuscular retraining (fNMR) is a noninvasive physical therapy widely used to treat peripheral facial palsies. It consists of different intervention methods that aim to reduce the debilitating sequelae of the disease. Recently, the use of mirror therapy in the acute facial palsy and postsurgical rehabilitation contexts has shown promising results, suggesting its use as an adjunct to fNMR in treating patients with later stages of paralysis, such as the paretic, early, or chronic synkinetic. Objective The main aim of this study is to compare the efficacy of an added mirror therapy component with fNMR in patients with peripheral facial palsy (PFP) sequelae in 3 different stages. The specific objectives of this study are to measure the effects of combined therapy compared to fNMR alone on (1) participants’ facial symmetry and synkinesis, (2) quality of life and psychological aspects of the participants, (3) motivation and treatment adherence, and (4) different stages of facial palsies. Methods This study is a randomized controlled trial that compares the effect of fNMR combined with mirror therapy (experimental group: n=45) with fNMR alone (control group: n=45) in 90 patients with peripheral facial palsy presenting with sequelae 3-12 months after onset. Both groups will receive 6 months of rehabilitation training. Facial symmetry and synkinesis; participants’ quality of life; and their psychological factors, motivation, and compliance will be assessed at baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) postintervention. Outcome measures are (1) changes in facial symmetry and synkinesis assessed with facial grading tools, (2) quality of life changes with patient questionnaires, and (3) therapy motivation with a standardized scale, as well as adherence to treatment with metadata. Changes in facial symmetry and synkinesis will be judged by 3 assessors blinded to group assignment. Mixed models and Kruskal-Wallis, chi-square, and multilevel analyses will be conducted according to the appropriate variable type. Results Inclusion will start in 2024 and is anticipated to be completed in 2027. The 12-month follow-up will be completed with the last patient in 2028. We expect patients included in this study to experience improvement in facial symmetry, synkinesis, and quality of life, regardless of group assignments. A potential benefit of mirror therapy for facial symmetry and synkinesis could be noted for patients in the paretic phase. We hypothesize better motivation and adherence to treatment for the mirror therapy group. Conclusions The results of this trial may provide new guidelines for PFP rehabilitation with patients dealing with long-term sequelae. It also fills the need for robust evidence-based data in behavioral facial rehabilitation. International Registered Report Identifier (IRRID) PRR1-10.2196/47709