NCT04102306

Brief Summary

Temporomandibular disorder (TMD) is the symptomatic expression of a muscular or an articular impairment at the manducatory tract. TMD affects between 30 to 65% of the population with a higher prevalence for young women. The patients with DTM report a decrease of their personal, social and professional quality of life. Treatment usually relies on physical therapy. Among the different technics that can be used in physical therapy, there is growing evidence advocating the efficacy of using motor imagery (i.e. imagining a movement with no concomitant physical execution) during rehabilitation. It has also been shown that the benefits of practicing motor imagery depend on the ability (i.e., the higher the ability, the greater the benefits). However, there is no investigation of the motor imagery ability of the tongue and mouth movements conditioning the use of motor imagery during TMD rehabilitation. The objective of the study is to investigate the ability of imagining tongue and mouth movements using the Tongue and Mouth Imagery Questionnaire (TMIQ) as compare to the gold-standard Kinesthetic and Visual Imagery Questionnaire (KVIQ - Malouin et al., 2007).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 6, 2020

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

September 19, 2019

Last Update Submit

March 4, 2020

Conditions

Keywords

orofacial myotherapies;physical therapy;assessment;questionnaire validation

Outcome Measures

Primary Outcomes (4)

  • vividness score of imagined movements of the TMIQ for the DTM group

    Averaged vividness score (using a 5-point likert scale, 1=minimum vividness, 5=maximal vividness) for the TMIQ for the DTM group

    at study inclusion, i.e day 1

  • vividness score of imagined movements of the TMIQ for the CTL group

    Averaged vividness score (using a 5-point likert scale, 1=minimum vividness, 5=maximal vividness) for the TMIQ for the DTM group

    at study inclusion, i.e day 1

  • vividness score of imagined movements of the KVIQ for the DTM group

    Averaged vividness score (using a 5-point likert scale, 1=minimum vividness, 5=maximal vividness) for the KVIQ for the DTM group

    at study inclusion, i.e day 1

  • vividness score of imagined movements of the KVIQ for the CTL group

    Averaged vividness score (using a 5-point likert scale, 1=minimum vividness, 5=maximal vividness) for the KVIQ for the DTM group

    at study inclusion, i.e day 1

Secondary Outcomes (5)

  • vividness score of imagined movements of the TMIQ for the DTM group

    at study completion, between 8 days to 45 days after inclusion

  • vividness score of imagined movements of the TMIQ for the CTL group

    at study completion, between 8 days to 45 days after inclusion

  • Temporal coupling to imagined movements of the TMIQ for the DTM group

    at study completion, between 8 days to 45 days after inclusion

  • Temporal coupling to imagined movements of the TMIQ for the CTL group

    at study inclusion, i.e day 1

  • Temporal coupling to imagined movements of the TMIQ for the CTL group

    at study completion, between 8 days to 45 days after inclusion

Other Outcomes (4)

  • mental representation of the maximal opening of the mouth for the DTM group

    at study inclusion, i.e day 1

  • mental representation of the maximal opening of the mouth for the CTL group

    at study inclusion, i.e day 1

  • Accuracy of tongue pointing against the wood examination stick for the DTM group

    at study inclusion, i.e day 1

  • +1 more other outcomes

Study Arms (2)

Temporomandibular disorder group (TMD)

Patients with temporomandibular disorder coming at the Cabinet Saint Alexandre for orofacial rehabilitation. Test 1: passation of the KVIQ questionnaire, followed by the passation of the TMIQ during a rehabilitation session supervised by the physical therapist (PT) Test 2: passation of the TMIQ during the next rehabilitation session supervised by the same PT(interval between PT session 1 and 2 is a maximum of 45 days). Questionnaires were performed during the course of the patient rehabilitation that was instructed not to perform imagined movement during the interval.

Other: reliability and validity construct of the TMIQ

Control healthy group (CTL)

Healthy individuals with no temporomandibular disorder (i.e., no orofacial medical consultation or rehabilitation) aged-matched and gender-matched to TMD group. Test 1: passation of the KVIQ questionnaire, followed by the passation of the TMIQ during a session supervised by the physical therapist (PT) Test 2: passation of the TMIQ during the next session supervised by the same PT(interval between PT session 1 and 2 is a maximum of 8 days). Questionnaires were performed with no additional rehabilitation and participants were instructed not to perform imagined movement during the interval.

Other: reliability and validity construct of the TMIQ

Interventions

comparison of the TMIQ to the gold-standard questionnaire (KVIQ) and test-retest

Control healthy group (CTL)Temporomandibular disorder group (TMD)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

47 participants with DTM 47 participants with no DTM (healthy control) age-matched and gender-matched to participants with DTM.

You may qualify if:

  • age between 18 and 75 years
  • A voluntary individual who has given informed consent after receiving clear, fair and appropriate information about the study.
  • For DTM group participants
  • beneficiary of the social security scheme

You may not qualify if:

  • The presence of a short tongue brake (Marchesan, 2005)
  • Lingual immaturity evaluated by the Tardieu test (Jouannaud et al. 1972)
  • Patients who had orthognathic surgery within 6 months post- operative, or facial fractures according to the same deadlines
  • The presence of peripheral facial palsy
  • Current participation in another research whose objective would be the evaluation of a therapeutic, drug or not, introducing an experimental bias.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabinet Saint Alexandre

Lyon, 69005, France

Location

Related Publications (1)

  • Alvarado C, Arminjon A, Damieux-Verdeaux C, Lhotte C, Condemine C, Cousin AS, Sigaux N, Bouletreau P, Mateo S. Impaired tongue motor control after temporomandibular disorder: A proof-of-concept case-control study of tongue print. Clin Exp Dent Res. 2022 Apr;8(2):529-536. doi: 10.1002/cre2.549. Epub 2022 Feb 27.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Caroline Alvarado-Faysse, PT

    Cabinet de kinésithérapie Saint Alexandre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
45 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 25, 2019

Study Start

September 26, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 6, 2020

Record last verified: 2019-09

Locations