Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery

NCT06263374 | Not Yet Recruiting

• 1 other identifier: 69HCL21_0355
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Keywords

Motor imagery; Maxillofacial physiotherapy; Orthognathic surgery

Outcome Measures

Primary Outcomes (1)

• Maximal mouth opening measured in millimeters using a caliper

  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.

  Day 30

Secondary Outcomes (10)

• Active maximum mouth opening in millimeter using a vernier caliper

  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

  Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180

• Maxillofacial pain

  Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180

• Body weight mass (kilograms)

  Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180

• Orthodontic associated treatment

  Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180

Study Arms (2)

Physiotherapy with self-rehabilitation including motor imagery

EXPERIMENTAL

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.

Behavioral: Motor imagery of the jaw

Physiotherapy with self-rehabilitation including control task

SHAM COMPARATOR

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.

Behavioral: Control task (Sudoku or Crossword puzzle)

Interventions

Motor imagery of the jaw 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 motor imagery

Control task (Sudoku or Crossword puzzle) 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.

Physiotherapy with self-rehabilitation including control task

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Cabinet Bataille

Lyon, 69003, France

Location

Cabinet de kinésithérapie Saint Alexandre

Lyon, 69005, France

Location

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location

MeSH Terms

Conditions

Maxillofacial Abnormalities

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sébastien MATEO

CONTACT

0478865066; sebastien.mateo@chu-lyon.fr

Pierre MD BOULETREAU

CONTACT

0478861934; pierre.bouletreau@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomization list will be centrally generated by an independent methodologist for each center and integrated into the electronic case report form. The physiotherapist will disclose the allocation to the participant during the inclusion visit, following clear, transparent, and appropriate information, and obtaining the participant's consent to participate in the study. This disclosure occurs after all measurements have been completed. The inclusion visit is scheduled 30 days ± 8 before the surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centric randomized controlled trial

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)