Temporomandibular DisorderTMIQNCT04102306
Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders
An observational study of Temporomandibular Disorder and Motor Imagery, run by Cabinet de Kinesitherapie SCM Saint-Alexandre at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Motor Imagery
- What is being tested?
- reliability and validity construct of the TMIQ
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2018to 31 Dec 2019
- How long will I take part?
- 45 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 47 participants with DTM 47 participants with no DTM (healthy control) age-matched and gender-matched to participants with DTM.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
- 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.
- Conditions
- Temporomandibular Disorder, Motor Imagery
- Being tested
- reliability and validity construct of the TMIQ
- Keywords
- orofacial myotherapies;, physical therapy;, assessment;, questionnaire validation
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reliability and validity construct of the TMIQOther
comparison of the TMIQ to the gold-standard questionnaire (KVIQ) and test-retest
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: reliability and validity construct of the TMIQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: at study inclusion, i.e day 1
Secondary outcomes (5)
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
Measured: at study completion, between 8 days to 45 days after inclusion
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
Measured: at study completion, between 8 days to 45 days after inclusion
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
Measured: at study completion, between 8 days to 45 days after inclusion
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
Measured: at study inclusion, i.e day 1
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
Measured: at study completion, between 8 days to 45 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start26 Sep 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 45 Days
Sponsor and investigators
- Lead sponsor
- Cabinet de Kinesitherapie SCM Saint-Alexandre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Lyon, Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Caroline Alvarado-Faysse, PT, Principal investigator, Cabinet de kinésithérapie Saint Alexandre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102306
- Sponsor's protocol ID
- TMIQ
- Acronym
- TMIQ
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04102306
- Acronym / sponsor ID
- TMIQ / TMIQ
- Conditions
- Temporomandibular Disorder, Motor Imagery
- Keywords
- orofacial myotherapies;, physical therapy;, assessment;, questionnaire validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cabinet de Kinesitherapie SCM Saint-AlexandreIndustry (pharma, biotech, devices)
- Collaborators
- University of Lyon, Hospices Civils de Lyon
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 45 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular disorder group (TMD) | – | Other: reliability and validity construct of the TMIQPatients 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. |
| Control healthy group (CTL) | – | Other: reliability and validity construct of the TMIQHealthy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 47 participants with DTM 47 participants with no DTM (healthy control) age-matched and gender-matched to participants with DTM.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reliability and validity construct of the TMIQcomparison of the TMIQ to the gold-standard questionnaire (KVIQ) and test-retest | Other | Control healthy group (CTL), Temporomandibular disorder group (TMD) |
Primary outcome
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
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
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
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
5 secondary outcomes
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
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
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
Temporal coupling to imagined movements of the TMIQ for the CTL group
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 35220688Alvarado 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Alvarado-Faysse, PT principal investigator
Cabinet de kinésithérapie Saint Alexandre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder and Motor Imagery, run by Cabinet de Kinesitherapie SCM Saint-Alexandre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vividness score of imagined movements of the TMIQ for the DTM group (time frame: at study inclusion, i.e day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.