UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056816 |
|---|---|
| Receipt number | R000064913 |
| Scientific Title | Development of an evaluation method based on a dual task during walking using mixed reality technology. |
| Date of disclosure of the study information | 2025/01/25 |
| Last modified on | 2025/01/25 16:41:48 |
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Basic information
Public title
Development of an evaluation method based on a dual task during walking using mixed reality technology.
Acronym
Development of a dual task assessment method for walking using mixed reality technology.
Scientific Title
Development of an evaluation method based on a dual task during walking using mixed reality technology.
Scientific Title:Acronym
Development of a dual task assessment method for walking using mixed reality technology.
Region
| Japan |
Condition
Condition
Cerebrovascular disorders, higher brain dysfunction, locomotive syndrome, sarcopenia, geriatric syndromes
Classification by specialty
| Geriatrics | Orthopedics | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fall prevention is an important issue in a super-aged society.One of the causes of falls is a decline in the ability to perform the double task of walking, which is related to attentional function.
This research aims to develop a new tool for quantitative and detailed evaluation of walking double task performance using Mixed Reality (MR) technology, which allows a wide variety of virtual objects that are difficult to place in the real world to be placed in a three-dimensional space in conjunction with the real world.The aim is to develop an evaluation method that combines existing attention function evaluation methods such as the Trail Making Test (TMT) with walking in a space reproduced by MR technology, and to realise a fall risk prediction evaluation that enables factor analysis classified by motor function and attention function.
This testing method can also be applied to create efficient rehabilitation protocols according to the subject's individual physical and cognitive functional level, and can be applied to the assessment and treatment of patients with motor dysfunction and higher brain dysfunction.
Basic objectives2
Others
Basic objectives -Others
The elements of the TMT, which are widely used in written tests on paper to assess attention disorders, are incorporated into a three-dimensional space using MR technology, and an element of gait is added to develop a behavioural test method that combines motor and cognitive function aspects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TMT-J Part A, Part B
Key secondary outcomes
CAT,MMSE-J,Timed Up & Go Test,FIM
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
As [MR treatment group], MR treatment is carried out at least twice a month for 30 minutes each time.
Interventions/Control_2
The exercises that are usually performed twice a week should be continued as [normal exercises group].
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Older people (65 years and over) living in the area who can walk at least 50 metres on their own.
Key exclusion criteria
Subjects who need assistance in walking, etc.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Kojima |
Organization
Okayama Healthcare Professional University
Division name
Faculty of Health Sciences Department of Physical Therapy
Zip code
700-0913
Address
3-2-18, Daiku, Kitaku, Okayama, Okayama
TEL
086-233-8020
kojima@opu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Kojima |
Organization
Okayama Healthcare Professional University
Division name
Faculty of Health Sciences Department of Physical Therapy
Zip code
700-0913
Address
3-2-18, Daiku, Kitaku, Okayama, Okayama
TEL
086-233-8020
Homepage URL
kojima@opu.ac.jp
Sponsor or person
Institute
Okayama Healthcare Professional University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Healthcare Professional University
Address
3-2-18, Daiku, Kitaku, Okayama, Okayama
Tel
086-233-8020
kojima@opu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064913
