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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Maxillofacial Abnormalities
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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
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
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
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
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
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
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
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
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
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.
- First posted16 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06263374
- Acronym / sponsor ID
- MAXIMAND / 69HCL21_0355
- Conditions
- Maxillofacial Abnormalities
- Keywords
- Motor imagery, Maxillofacial physiotherapy, Orthognathic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-centric randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy with self-rehabilitation including motor imagery | Experimental | Behavioral: Motor imagery of the jawPatients 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. |
| Physiotherapy with self-rehabilitation including control task | Sham comparator | Behavioral: Control task (Sudoku or Crossword puzzle)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor imagery of the jawFifty 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. | Behavioural | Physiotherapy with self-rehabilitation including motor imagery |
| 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. | Behavioural | Physiotherapy with self-rehabilitation including control task |
Primary outcome
Maximal mouth opening measured in millimeters using a caliper
Time frame: Day 30
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.
10 secondary outcomes
Active maximum mouth opening in millimeter using a vernier caliper
Time frame: 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
Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
Maxillofacial pain
Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
Body weight mass (kilograms)
Time frame: Day 0 ; Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90 ; Day 180
Orthodontic associated treatment
Time frame: 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
Time frame: Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90
Orofacial function
Time frame: Day-30 ; Day 30 ; Day 90 ; Day 180
Maxillofacial quality of life
Time frame: Day-30 ; Day 30 ; Day 90 ; Day 180
Level of achievement of the goals set by the patient before surgery
Time frame: Day-30 ; Day 90 ; Day 180
Motor imagery capability
Time frame: Day-30 ; Day 90 ; Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
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.