Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery

NCT ID: NCT06263374

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2028-03-31

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.

Conditions

Maxillofacial Abnormalities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physiotherapy with self-rehabilitation including motor imagery

Patients will undergo maxillofacial rehabilitation, comprising a single 30-minute session per week during the first month post-surgery, followed by one session every two weeks for up to three months. In between these sessions, patients will participate in a self-rehabilitation program at home, involving jaw and tongue movements as well as massages, each lasting 5 minutes, three times a day. Compliance with the program will be monitored by the physiotherapist. The program has been standardized across all centers, ensuring consistency in this multicentric study.

Group Type: EXPERIMENTAL

Motor imagery of the jaw

Intervention Type: BEHAVIORAL

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.

Physiotherapy with self-rehabilitation including control task

Patients allocated to the control group will receive physiotherapy along with self-rehabilitation, incorporating a control task. The delivery of physiotherapy and self-rehabilitation will mirror that of the experimental group. The control task, substituting motor imagery, will involve completing Sudoku or crossword puzzles based on patient preference. (i.e., an equivalent duration to the motor imagery practice of the experimental group). The physiotherapist will ensure adherence to the rehabilitation and intervention protocols.

Group Type: SHAM_COMPARATOR

Control task (Sudoku or Crossword puzzle)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cabinet Bataille

Lyon, , France

Cabinet de kinésithérapie Saint Alexandre

Lyon, , France

Hôpital Henry Gabrielle

Saint-Genis-Laval, , France

Countries

France

Central Contacts

Sébastien MATEO

Role: CONTACT

sebastien.mateo@chu-lyon.fr

0478865066 ext. +33

Pierre MD BOULETREAU

Role: CONTACT

pierre.bouletreau@chu-lyon.fr

0478861934 ext. +33

Facility Contacts

Guillaume Nainani

Role: primary

guillaume.nainani@gmail.com

0478011908 ext. +33

Caroline Alvarado-Faysse

Role: primary

c.alvarado.faysse@gmail.com

0437410332 ext. +33

Sébastien Matéo

Role: primary

sebastien.mateo@chu-lyon.fr

0478865066 ext. +33

Other Identifiers

69HCL21_0355

Identifier Type: -

Identifier Source: org_study_id