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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Maximal mouth opening measured in millimeters using a caliper
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Motor imagery of the jaw (Behavioral)
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.
干预措施: Control task (Sudoku or Crossword puzzle) (Behavioral)
结局指标
主要结局
Maximal mouth opening measured in millimeters using a caliper
时间窗: 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.
次要结局
- 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)
- 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)
- Orthodontic associated treatment(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(Day 7 ; Day 14 ; Day 21 ; Day 30 ; Day 45 ; Day 60 ; Day 75 ; Day 90)
- Orofacial function(Day-30 ; Day 30 ; Day 90 ; Day 180)
- Motor imagery capability(Day-30 ; Day 90 ; Day 180)
- Maxillofacial quality of life(Day-30 ; Day 30 ; Day 90 ; Day 180)
- Level of achievement of the goals set by the patient before surgery(Day-30 ; Day 90 ; Day 180)