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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name