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CompletedNCT04102306TMIQUpdated Mar 6, 2020

Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders

An observational study in Temporomandibular Disorder and Motor Imagery, sponsored by Cabinet de Kinesitherapie SCM Saint-Alexandre. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-06.

Sponsored by Cabinet de Kinesitherapie SCM Saint-Alexandre · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
94
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed description

Principal objective:

Assess the validity construct of the Tongue and Mouth Imagery Questionnaire (TMIQ) as compare to the gold-standard Kinesthetic and Visual Imagery Questionnaire (KVIQ - Malouin et al., 2007), both measuring the motor imagery vividness.

Secondary objectives:

  1. Assess the reliability of the TMIQ using a test-retest.
  2. Assess the temporal coupling (i.e., the ratio between imagined and physically practiced movement) and compare these ratios for the TMIQ and KVIQ.
  3. Investigate the effect of TMD by comparing the vividness scores of TMIQ for respectively subject with and with no TMD.
  4. Investigate the effect of TMD by comparing the vividness scores of KVIQ for respectively subject with and with no TMD.
  5. Investigate the effect of TMD by comparing the temporal coupling scores of TMIQ for respectively subject with and with no TMD.
  6. Investigate the effect of TMD by comparing the temporal coupling scores of KVIQ for respectively subject with and with no TMD.
02

Conditions studied

  • Temporomandibular Disorder
  • Motor Imagery

Keywords

  • orofacial myotherapies;
  • physical therapy;
  • assessment;
  • questionnaire validation
03

In context

Temporomandibular Joint Disorders

621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.

This study's enrollment of 94 is close to the median of 90 across 171 observational studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

This is the only study on the registry with Cabinet de Kinesitherapie SCM Saint-Alexandre as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

  • inclusion during the DTM rehabilitation in the physical therapy firm "Cabinet Saint Alexandre".
  • beneficiary of the social security scheme

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
94 participants (actual)
Target follow-up
45 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • Otherreliability and validity construct of the TMIQ

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at study inclusion, i.e day 1

  2. 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

    Time frame: at study inclusion, i.e day 1

  3. 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

    Time frame: at study inclusion, i.e day 1

  4. 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

    Time frame: at study inclusion, i.e day 1

Secondary outcomes

  1. 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

    Time frame: at study completion, between 8 days to 45 days after inclusion

  2. 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

    Time frame: at study completion, between 8 days to 45 days after inclusion

  3. Temporal coupling to imagined movements of the TMIQ for the DTM group

    Computation of ratio between imagined and physically practiced movements measured during the TMIQ for the DTM group

    Time frame: at study completion, between 8 days to 45 days after inclusion

  4. Temporal coupling to imagined movements of the TMIQ for the CTL group

    Computation of ratio between imagined and physically practiced movements measured during the TMIQ for the DTM group

    Time frame: at study inclusion, i.e day 1

  5. Temporal coupling to imagined movements of the TMIQ for the CTL group

    Computation of ratio between imagined and physically practiced movements measured during the TMIQ for the DTM group

    Time frame: at study completion, between 8 days to 45 days after inclusion

Other outcomes

  1. mental representation of the maximal opening of the mouth for the DTM group

    comparison of the score (5-point likert Scale, 1= minimal opening, 5=maximal opening) self-reported by the participant after imagination of maximal mouth opening as compared to the score of the physical therapist after the physical execution of mouth opening by the participant during the TMIQ for the DTM group

    Time frame: at study inclusion, i.e day 1

  2. mental representation of the maximal opening of the mouth for the CTL group

    comparison of the score (5-point likert Scale, 1= minimal opening, 5=maximal opening) self-reported by the participant after imagination of maximal mouth opening as compared to the score of the physical therapist after the physical execution of mouth opening by the participant during the TMIQ for the CTL group

    Time frame: at study inclusion, i.e day 1

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

    Measure the surface of the tongue print after that participant was requested to point as accurately as possible while keeping the tongue sharp against the wood examination stick for the DTM group

    Time frame: at study inclusion, i.e day 1

  4. Accuracy of tongue pointing against the wood examination stick for the CTL group

    Measure the surface of the tongue print after that participant was requested to point as accurately as possible while keeping the tongue sharp against the wood examination stick for the CTL group

    Time frame: at study inclusion, i.e day 1

07

Study locations

1 site
  • Cabinet Saint Alexandre
    Lyon, 69005, France
08

References and documents

Publications

  • 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. PubMed 35220688 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Dec 2019, 15 months.

Of 60 observational studies under Temporomandibular Joint Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 15 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2019
First posted
Sep 25, 2019
StartActual
Sep 26, 2018
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Mar 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04102306
Lead sponsor
Cabinet de Kinesitherapie SCM Saint-Alexandre
Collaborators
University of Lyon, Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Sep 26, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Mar 6, 2020

Study contacts

Caroline Alvarado-Faysse, PT
principal investigator · Cabinet de kinésithérapie Saint Alexandre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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