Clinical trial NCT06263374: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maxillofacial Abnormalities
Keywords: Motor imagery
Maxillofacial physiotherapy
Orthognathic surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centric randomized controlled trial
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Maximal mouth opening measured in millimeters using a caliper
timeFrame: Day 30
Secondary outcomes:
measure: Active maximum mouth opening in millimeter using a vernier caliper
timeFrame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
measure: Active jaw range of motion (ROM) other than maximal opening
timeFrame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
measure: Maxillofacial pain
timeFrame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
measure: Body weight mass (kilograms)
timeFrame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
measure: Orthodontic associated treatment
timeFrame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
measure: Compliance with physiotherapy and intervention
timeFrame: Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90
measure: Orofacial function
timeFrame: Day-30 ; Day 30 ; Day 90 ; Day 180
measure: Maxillofacial quality of life
timeFrame: Day-30 ; Day 30 ; Day 90 ; Day 180
measure: Level of achievement of the goals set by the patient before surgery
timeFrame: Day-30 ; Day 90 ; Day 180
measure: Motor imagery capability
timeFrame: Day-30 ; Day 90 ; Day 180
Other outcomes:
Locations:
city: Lyon
country: France
facility: Cabinet Bataille
city: Lyon
country: France
facility: Cabinet de kinésithérapie Saint Alexandre
city: Saint-Genis-Laval
country: France
facility: Hôpital Henry Gabrielle
Study officials:
References: