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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04102306
Other study ID # TMIQ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 26, 2018
Est. completion date December 31, 2019

Study information

Verified date September 2019
Source Cabinet de Kinesitherapie SCM Saint-Alexandre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
reliability and validity construct of the TMIQ
comparison of the TMIQ to the gold-standard questionnaire (KVIQ) and test-retest

Locations

Country Name City State
France Cabinet Saint Alexandre Lyon

Sponsors (3)

Lead Sponsor Collaborator
Cabinet de Kinesitherapie SCM Saint-Alexandre Hospices Civils de Lyon, University of Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 at study inclusion, i.e day 1
Other 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 at study inclusion, i.e day 1
Other 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 at study inclusion, i.e day 1
Other 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 at study inclusion, i.e day 1
Primary 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
Primary 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
Primary 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
Primary 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 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 completion, between 8 days to 45 days after inclusion
Secondary 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 completion, between 8 days to 45 days after inclusion
Secondary 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 at study completion, between 8 days to 45 days after inclusion
Secondary 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 at study inclusion, i.e day 1
Secondary 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 at study completion, between 8 days to 45 days after inclusion
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