UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025969 |
|---|---|
| Receipt number | R000029854 |
| Scientific Title | Development and evaluation of neurorehabilitation for the temporomandibular disorders |
| Date of disclosure of the study information | 2017/02/04 |
| Last modified on | 2024/02/08 13:09:04 |
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Basic information
Public title
Development and evaluation of neurorehabilitation for the temporomandibular disorders
Acronym
Neurorehabilitation for the temporomandibular disorders
Scientific Title
Development and evaluation of neurorehabilitation for the temporomandibular disorders
Scientific Title:Acronym
Neurorehabilitation for the temporomandibular disorders
Region
| Japan |
Condition
Condition
Temporomandibular disorders
Classification by specialty
| Oral surgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and evaluation of physical therapy for the temporomandibular disorders using neurorehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reaction time and accuracy of mental rotation task
pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Usual care and Mental Rotation training
once a day(About 15 mins), 3months
Interventions/Control_2
Usual care only
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with temporomandibular disorders and healthy adults
Key exclusion criteria
People who have the current and past history of disease in the stomatognathic system other than the temporomandibular disorders.
Psychiatric disease parients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakayama |
Organization
Kio University
Division name
Department of general affairs
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
h.nakayama@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nara Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@kio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
奈良県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Reaction time and accuracy of mental rotation task are compared between patients with temporomandibular disorders and healthy controls
The association between reaction time and accuracy of mental rotation task, and psycosocial aspects in each group are investigated.
The association between the change of reaction time and accuracy of mental rotation task, and the change of symptom and psychosocial aspect are investigated.
Management information
Registered date
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029854
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
