UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053291 |
|---|---|
| Receipt number | R000060821 |
| Scientific Title | Effectiveness of physical training using Fully Immersive Virtual Reality for patients with motor and balance dysfunction due to stroke |
| Date of disclosure of the study information | 2024/01/09 |
| Last modified on | 2024/04/04 15:36:35 |
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Basic information
Public title
Effectiveness of physical training using Fully Immersive Virtual Reality for patients with motor and balance dysfunction due to stroke
Acronym
Effectiveness of physical training using Fully Immersive Virtual Reality for patients with motor and balance dysfunction due to stroke
Scientific Title
Effectiveness of physical training using Fully Immersive Virtual Reality for patients with motor and balance dysfunction due to stroke
Scientific Title:Acronym
Effectiveness of physical training using Fully Immersive Virtual Reality for patients with motor and balance dysfunction due to stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the feasibility of rehabilitation training using Fully Immersive Virtual Reality for stroke patients with motor and balance dysfunction and to evaluate its effectiveness in terms of motor paralysis and balance function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BBS (Berg Balance Scale) 2 weeks after the start of rehabilitation training using Fully Immersive Virtual Reality
Key secondary outcomes
DGI(Dynamic Gait Index), TUG(Timed Up and Go test), 10-m walk test, Brunnstrom Stage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rehabilitation training using Fully Immersive Virtual Reality will be provided for 20 minutes per day in combination with conventional physical therapy. This combined training will be conducted 5 days a week for 2 weeks (total of 10 sessions) for continuous intervention.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the Convalescent Rehabilitation Ward of the International University of Health and Welfare Ichikawa Hospital and provided with rehabilitation due to a stroke diagnosis, who meet the following conditions.
1) Patients who have suffered a stroke and present with motor paralysis and balance disorders
2) Able to obtain written consent
3) Able to maintain sitting and standing posture by themselves
4) BBS shows no change for 1 week before intervention entry
5) Patients with a first stroke and a follow-up period of 90 days or less after stroke onset
Key exclusion criteria
1) Patients who have difficulty with even simple conversation due to severe cognitive dysfunction
2) Severe visual impairment
3) Uncontrollable epileptic seizures
4) Complications of orthopedic or internal diseases that limit walking
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kanta |
| Middle name | |
| Last name | Kitabayashi |
Organization
International university of health and welfare Graduate School of Medicine, Department of Clinical Medical Sciences, Rehabilitation Medicine
Division name
Department of rehabilitation
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa city, Chiba prefecture, Japan
TEL
047-375-1111
kanta@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kanta |
| Middle name | |
| Last name | Kitabayashi |
Organization
International university of health and welfare Ichikawa hospital
Division name
Rehabilitation
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa city, Chiba prefecture, Japan
TEL
047-375-1111
Homepage URL
kanta@iuhw.ac.jp
Sponsor or person
Institute
International university of health and welfare Ichikawa hospital, Dep, of rehabilitation
Institute
Department
Personal name
Funding Source
Organization
International university of health and welfare Ichikawa hospital, Dep, of rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Chiba District Ethics Review Board
Address
4-3, Kozunomori, Narita city, Chiba prefecture, Japan
Tel
0476-20-7708
rinri_md@iuhw.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 | 01 | Month | 09 | 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 | 10 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060821
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