- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102306
Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders (TMIQ)
Assessing Motor Imagery Using the Tongue and Mouth Imagery Questionnaire (TMIQ) in Patients With Temporomandibular Disorder and Healthy Control Subjects: a Reliability and Construct Validity Study
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Assess the reliability of the TMIQ using a test-retest.
- Assess the temporal coupling (i.e., the ratio between imagined and physically practiced movement) and compare these ratios for the TMIQ and KVIQ.
- Investigate the effect of TMD by comparing the vividness scores of TMIQ for respectively subject with and with no TMD.
- Investigate the effect of TMD by comparing the vividness scores of KVIQ for respectively subject with and with no TMD.
- Investigate the effect of TMD by comparing the temporal coupling scores of TMIQ for respectively subject with and with no TMD.
- Investigate the effect of TMD by comparing the temporal coupling scores of KVIQ for respectively subject with and with no TMD.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69005
- Cabinet Saint Alexandre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
comparison of the TMIQ to the gold-standard questionnaire (KVIQ) and test-retest
|
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. |
comparison of the TMIQ to the gold-standard questionnaire (KVIQ) and test-retest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vividness score of imagined movements of the TMIQ for the DTM group
Time Frame: at study inclusion, i.e day 1
|
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
Time Frame: at study inclusion, i.e day 1
|
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
Time Frame: at study inclusion, i.e day 1
|
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
Time Frame: at study inclusion, i.e day 1
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vividness score of imagined movements of the TMIQ for the DTM group
Time Frame: at study completion, between 8 days to 45 days after inclusion
|
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
|
vividness score of imagined movements of the TMIQ for the CTL group
Time Frame: at study completion, between 8 days to 45 days after inclusion
|
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
|
Temporal coupling to imagined movements of the TMIQ for the DTM group
Time Frame: at study completion, between 8 days to 45 days after inclusion
|
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
|
Temporal coupling to imagined movements of the TMIQ for the CTL group
Time Frame: at study inclusion, i.e day 1
|
Computation of ratio between imagined and physically practiced movements measured during the TMIQ for the DTM group
|
at study inclusion, i.e day 1
|
Temporal coupling to imagined movements of the TMIQ for the CTL group
Time Frame: at study completion, between 8 days to 45 days after inclusion
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mental representation of the maximal opening of the mouth for the DTM group
Time Frame: at study inclusion, i.e day 1
|
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
|
mental representation of the maximal opening of the mouth for the CTL group
Time Frame: at study inclusion, i.e day 1
|
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
|
Accuracy of tongue pointing against the wood examination stick for the DTM group
Time Frame: at study inclusion, i.e day 1
|
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
|
Accuracy of tongue pointing against the wood examination stick for the CTL group
Time Frame: at study inclusion, i.e day 1
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Caroline Alvarado-Faysse, PT, Cabinet de kinésithérapie Saint Alexandre
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMIQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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