UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038469 |
|---|---|
| Receipt number | R000043836 |
| Scientific Title | Home-based Virtual Reality Rehabilitation for the Upper Extremity in Chronic Stroke (Randomized-control trial) |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2024/01/16 10:18:48 |
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Basic information
Public title
Home-based Virtual Reality Rehabilitation for the Upper Extremity in Chronic Stroke
Acronym
Home-based VR rehabilitation for stroke
Scientific Title
Home-based Virtual Reality Rehabilitation for the Upper Extremity in Chronic Stroke (Randomized-control trial)
Scientific Title:Acronym
Home-based VR rehabilitation for stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of home-based virtual reality rehabilitation with using RAPAEL Smart Glove for the upper Extremity and quality of life in chronic stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Fugl-Meyer assessment
Key secondary outcomes
Number of times of executing home program during 4 weeks intervention term
Jebsen-Taylor hand function test
Box & Block Test
Motor Activity Log
Stroke Impact Scale
Modefied Ashworth Scale
Questionnaire about exercise
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
home program with using VR Smart Glove for 30 min a day, 5 days in a week, for 4 weeks
Interventions/Control_2
home program without using VR Smart Glove for 30 min a day, 5 days in a week, for 4 weeks
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
1) Age 20 and older
2) Diagnosis of stroke at least three months prior to enrollment
3) Unilateral upper extremity functional deficit after stroke
4) Manual Muscle Testing of wrist flexion/extension, forearm pronation/supination or finger flexion/extension are 2 or more.
5) Able to provide informed consent
6) Able to provide themselves own written subscription by their own volition after informed consent about this investigation
Key exclusion criteria
1) Predisposing psychological disorders which could impede participation
2) Severe aphasia resulting in communication difficulties
3) Severe pain impeding upper extremity rehabilitation
4) Pre-existing neurological disorder that causes motor deficits
5) Existence of contraindication for RAPAEL Smart Glove
6) Individual who is evaluated inadequacy to enroll this study by lead principal investigator of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Fujiwara |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
t-fujiwara@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Fujiwara |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
t-fujiwara@juntendo.ac.jp
Sponsor or person
Institute
Juntendo 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
Juntendo University Hospital Ethical Review management Unit
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
（Juntendo University Hospital (Tokyo)）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043836
