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Maxillofacial AbnormalitiesMAXIMANDNCT06263374

Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery

A study testing Motor imagery of the jaw in people with Maxillofacial Abnormalities, run by Hospices Civils de Lyon at 3 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Maxillofacial Abnormalities
What is being tested?
Motor imagery of the jaw
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
3 sitesFrance
Study dates
1 Mar 2024to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France3 sites
  • Cabinet Bataille

    Lyon, 69003

    Guillaume Nainani, 0478011908 ext. +33, guillaume.nainani@gmail.com

  • Cabinet de kinésithérapie Saint Alexandre

    Lyon, 69005

    Caroline Alvarado-Faysse, 0437410332 ext. +33, c.alvarado.faysse@gmail.com

  • Hôpital Henry Gabrielle

    Saint-Genis-Laval, 69230

    Sébastien Matéo, 0478865066 ext. +33, sebastien.mateo@chu-lyon.fr

Other trials in France

About this study

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

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.

Being tested
Motor imagery of the jaw, Control task (Sudoku or Crossword puzzle)
Keywords
Motor imagery, Maxillofacial physiotherapy, Orthognathic surgery
Medical subject headings
Maxillofacial Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor imagery of the jawBehavioural

    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)Behavioural

    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 groups in NCT06263374
Study groupRoleWhat they receive
Physiotherapy with self-rehabilitation including motor imageryExperimentalPatients 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.
Receives: Behavioral: Motor imagery of the jaw
Physiotherapy with self-rehabilitation including control taskSham comparatorPatients 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.
Receives: Behavioral: Control task (Sudoku or Crossword puzzle)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 30

Secondary outcomes (10)
  1. Active maximum mouth opening in millimeter using a vernier caliper

    Compare active maximum mouth opening in millimeter obtained using a vernier caliper between the experimental group (i.e., motor imagery of the maxillofacial region [MI maxillofacial] + maxillofacial physiotherapy) and the control group (control cognitive task [watching a non-emotional content film or filling out a crossword or Sudoku grid] + maxillofacial physiotherapy), taking into account the possibility of orthodontic treatment with prescribed and effectively worn retention elastics.

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

  2. Active jaw range of motion (ROM) other than maximal opening

    Active range of motion for maximum mouth opening in millimeters measured using a caliper between the maxillary and mandibular incisors on the midline. Forward and lateral jaw movements will be measure by the same evaluator blinded to the randomization group.

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

  3. Maxillofacial pain

    Pain at rest and during jaw movements will be assessed using the 0-100mm Visual Analog Scale (VAS) (0=no pain, 100=maximum imaginable pain). In the evaluation of acute pain, the Visual Analog Scale is commonly used as it is a reliable, valid, sensitive, and suitable measurement tool (Sirintawat et al., 2017). Analgesic consumption will be recorded through patient inquiry at each physiotherapy session.

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

  4. Body weight mass (kilograms)

    The patient will be weighed using a scale at the end of each physiotherapy session.

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

  5. Orthodontic associated treatment

    Orthodontic treatment concurrent with physiotherapy will be systematically assessed at each physiotherapy session by questioning the patient, including an inquiry about any prescribed orthodontic measures and the use of retention elastics, as these factors may impact the maximum mouth opening.

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

  6. Compliance with physiotherapy and intervention

    This will include i) the physiotherapy number (n=8) and duration (each session duration = 30 min), ii) the compliance with active movement performed self-rehabilitation (both motor imagery control groups) indicated by the number of movement practiced per day, iii) compliance with intervention (motor imagery or control). The physiotherapist will supervised and verify the patient's compliance all along the study.

    Measured: Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90

  7. Orofacial function

    It will be measured using the Jaw Functional Limitation Scale 8 items. The patient will rate each item from 0 (no discomfort) to 10 (complete limitation). The maximum total score is 80. This scale includes items specifically assessing chewing, vertical jaw mobility, as well as verbal and emotional expression. The questionnaire is reliable (Ohrbach, Larsson, et al., 2008).

    Measured: Day-30 ; Day 30 ; Day 90 ; Day 180

  8. Maxillofacial quality of life

    It will be measure using the Orthognathic Quality of Life Questionnaire with 22 items. Each item is assessed from 0=no discomfort to 4=major discomfort, with a maximum total score of 88. Four sub-domains are evaluated: aesthetics (max subscore=20, items 1, 7, 10-11, 14), function (max subscore=20, items 2-6), awareness of facial deformity (max subscore=16, items 8-9, 12-13), and social impact (max subscore=32; items 15 to 22) (Cunningham et al., 2000).

    Measured: Day-30 ; Day 30 ; Day 90 ; Day 180

  9. Level of achievement of the goals set by the patient before surgery

    We will use the Goal Attainment Scale (Krasny-Pacini et al., 2013). Before surgery, the patient will choose the 3 items that they consider to be the most critical/disturbing among the various domains impacted by dento-maxillary dysmorphosis, The patient will indicate the level of achievement for each of these goals [initial pre-treatment level = -2 ; progress toward the goal without reaching it = -1 ; expected level after treatment = 0 ; "most likely" level after treatment = +1 ; successful goal better than expected = +2]

    Measured: Day-30 ; Day 90 ; Day 180

  10. Motor imagery capability

    Motor imagery capability will be measured by the Tongue Mouth Imagery Questionnaire by the same blind and experienced physical therapist. It consists in scoring the vividness of motor imagery movement using a 5-point Likert scale separating the visual and kinesthetic modalities (1: no image/sensation, 5: image as clear / sensation as intense as during overt movement).

    Measured: Day-30 ; Day 90 ; Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-centric randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06263374
Sponsor's protocol ID
69HCL21_0355
Acronym
MAXIMAND
Status last verified
Feb 2024
First submitted
1 Feb 2024
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motor imagery of the jaw in people with Maxillofacial Abnormalities, run by Hospices Civils de Lyon at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sébastien MATEO (0478865066 ext. +33, sebastien.mateo@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal mouth opening measured in millimeters using a caliper (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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