Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Maximal mouth opening measured in millimeters using a caliper [Срок оценки: Day 30]

Вторичные конечные точки (10)

• Active maximum mouth opening in millimeter using a vernier caliper [Срок оценки: 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 [Срок оценки: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Maxillofacial pain [Срок оценки: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Body weight mass (kilograms) [Срок оценки: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180]
• Orthodontic associated treatment [Срок оценки: 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 [Срок оценки: Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90]
• Orofacial function [Срок оценки: Day-30 ; Day 30 ; Day 90 ; Day 180]
• Maxillofacial quality of life [Срок оценки: Day-30 ; Day 30 ; Day 90 ; Day 180]
• Level of achievement of the goals set by the patient before surgery [Срок оценки: Day-30 ; Day 90 ; Day 180]
• Motor imagery capability [Срок оценки: Day-30 ; Day 90 ; Day 180]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

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

Идентификаторы

NCT: NCT06263374 · 69HCL21_0355

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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