UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038469
Receipt No. 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 2019/11/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email t-fujiwara@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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 Enrolling by invitation
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
2022 Year 08 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
2019 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043836

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.