UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055986 |
|---|---|
| Receipt number | R000063643 |
| Scientific Title | Long-term effectiveness of a prosthetic walking program in combination with Virtual Reality |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2024/10/30 00:03:29 |
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Basic information
Public title
Long-term effectiveness of a prosthetic walking program in combination with Virtual Reality
Acronym
Long-term effects of Virtual Reality on prosthetic walking program
Scientific Title
Long-term effectiveness of a prosthetic walking program in combination with Virtual Reality
Scientific Title:Acronym
Long-term effects of Virtual Reality on prosthetic walking program
Region
| Japan |
Condition
Condition
Healthy adult men and women aged 18 and over enrolled at Hiroshima University
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the observation of subjective gait images using Virtual Reality and in- situ foot-step movements in accordance with the images are effective for the acquisition of prosthetic gait
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10 m walking time
Both pre- and post-measurements (four weeks after the pre-measurement) are carried out three times each and the average of the three measurements is calculated. During walking, an assistant is attached to the side of the simulated prosthesis to ensure safety with light assistance.
Key secondary outcomes
Body centre of gravity acceleration during 10 m walking time measurement.
Timed up and go test
Measurement of centre-of-gravity sway
Degree of immersion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The VR video viewing group wears a simulated prosthetic leg and performs in-situ stepping movements on the parallel bars for five minutes each time, twice a week for four weeks. The participants are asked to perform the stepping movements in accordance with the gait in the VR video, while viewing the images taken subjectively of walking with a prosthetic leg in the VR space.
Interventions/Control_2
The control group wears a simulated prosthetic leg and performs in-situ stepping movements in the parallel bars for five minutes each time, twice a week for four weeks. The control group, unlike the VR video viewing group, does not watch the video.
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
(i) Healthy adult men and women aged 18 years or older at the time consent is obtained.
(ii) Persons whose consent to participate in this study can be obtained in writing
(iii) Persons who are able to wear a simulated prosthetic leg.
Key exclusion criteria
(i) Persons who are in a vulnerable position as a research subject because the principal investigator or research assistant and the research subject are in a teacher-student relationship and the student is attending a lecture given by the research officer
(ii) Persons who are prone to VIMS
(iii) Other persons deemed inappropriate by the person in charge of the research.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Maeda |
Organization
Hiroshima University
Division name
Department of Sports Rehabilitation, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-257-5410
norimmi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Maeda |
Organization
Hiroshima University
Division name
Department of Sports Rehabilitation, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-257-5410
Homepage URL
norimmi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.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
| 2024 | Year | 10 | Month | 30 | 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
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063643
