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Starting soon Not applicable

Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery

NCT06263374 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-03-01
Last updated
2024-02-16

Condition(s) studied

Maxillofacial Abnormalities

Investigational drug(s) / intervention(s)

Motor imagery of the jawControl task (Sudoku or Crossword puzzle)

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 is multicentric.

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 monitored by the physiotherapist. The program has been standardized across all participating centers, as the study is multicentric.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Maximal mouth opening measured in millimeters using a caliper — Day 30
    Active range of motion for maximum mouth opening in millimeters measured using a caliper between the maxillary and mandibular incisors on the midline. This measure has an excellent reliability (Best et al., 2013), including in case of orthognathic surgery (Ellis et al., 1989) (Ueki et al., 2008). The minimum clinical change is 5 mm for patients experiencing a reduction in maximum mouth opening due to pain (Kropmans et al., 1999). This measurement will be performed by an evaluator blinded to the randomization group.

Trial sites (3)

FacilityCityRegionStatus
Cabinet Bataille Lyon France
Cabinet de kinésithérapie Saint Alexandre Lyon France
Hôpital Henry Gabrielle Saint-Genis-Laval France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06263374 on ClinicalTrials.gov ↗ ← All trials in France