Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery

Official title

Effect of Maxillofacial Physiotherapy With Addition of Motor Imagery vs Sham on the Recovery of Mobility, Jaw Function, and Quality of Life After Orthognathic Surgery: A Single-Blind Randomized Controlled Study

Overview

Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or Sudoku grid\] to maxillofacial physiotherapy.

Interventions

• Behavioral Motor imagery of the jaw
  Fifty individuals who have undergone orthognathic surgery of the mandible alone or concurrently with the maxilla will be randomly assigned to the experimental group, which involves practicing motor imagery in addition to a self-rehabilitation program and physiotherapy. Patients will be guided to visualize three sets of jaw movements three times a day. Adherence to the program will be monitored by the physiotherapist. The program has been standardized across all participating centers as the study
• Behavioral Control task (Sudoku or Crossword puzzle)
  Fifty individuals who have undergone orthognathic surgery of the mandible alone or concurrently with the maxilla will be randomly assigned to the control group, which involves practicing a control task (completion of Sudoku or crossword puzzles) in addition to a self-rehabilitation program and physiotherapy. Patients will be instructed to engage in the task for approximately 10 minutes per day, equivalent to the duration of motor imagery practice in the group 1. Adherence to the program will be

Primary outcome measures

• Maximal mouth opening measured in millimeters using a caliper [Time frame: Day 30]

Secondary outcome measures (10)

• Active maximum mouth opening in millimeter using a vernier caliper [Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Active jaw range of motion (ROM) other than maximal opening [Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Maxillofacial pain [Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Body weight mass (kilograms) [Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Orthodontic associated treatment [Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Compliance with physiotherapy and intervention [Time frame: Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90]
• Orofacial function [Time frame: Day-30 ; Day 30 ; Day 90 ; Day 180]
• Maxillofacial quality of life [Time frame: Day-30 ; Day 30 ; Day 90 ; Day 180]
• Level of achievement of the goals set by the patient before surgery [Time frame: Day-30 ; Day 90 ; Day 180]
• Motor imagery capability [Time frame: Day-30 ; Day 90 ; Day 180]

Eligibility criteria

Inclusion criteria

• Volunteer after orthognathic surgery of the mandible alone or concurrently with the maxilla.
• Consent to participate to the study after receiving clear, loyal and appropriate information.
• Aged ≥ 18 years.
• Health care beneficiary

Exclusion criteria

• Patient who has undergone maxillary surgery alone (e.g., LeFort I) or genioplasty. Indeed, both of these surgeries typically have a favorable and rapid recovery without the need for maxillofacial physiotherapy.
• Patient unable to imagine a maximum mouth opening movement (i.e., score = 1, no mental image / no sensations) on the 5-point Likert scale used during the administration of the Tongue Month Imagery Questionnaire (TMIQ).
• Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias.
• Patients not undergoing rehabilitation in the study centers.
• Patients under guardians, curators, or legal protection.
• Pregnant or lactating patients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

France · 3 centers

• Cabinet Bataille — Lyon
• Cabinet de kinésithérapie Saint Alexandre — Lyon
• Hôpital Henry Gabrielle — Saint-Genis-Laval

Identifiers

NCT: NCT06263374 · 69HCL21_0355

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗