UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033299
Receipt number R000037961
Scientific Title Development of training methods and verification of effectiveness using upper limb rehabilitation robot in patients with hemiplegia
Date of disclosure of the study information 2018/07/05
Last modified on 2019/07/14 07:41:06

* 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

Development of training methods and verification of effectiveness using upper limb rehabilitation robot in patients with hemiplegia

Acronym

Study on upper limb rehabilitation robot in patients with hemiplegia

Scientific Title

Development of training methods and verification of effectiveness using upper limb rehabilitation robot in patients with hemiplegia

Scientific Title:Acronym

Study on upper limb rehabilitation robot in patients with hemiplegia

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 develop the appropriate training methods and to verify the effectiveness with the upper limb rehabilitation robot in hemiplegic patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Simple Test for Evaluating Hand Function (STEF)

Key secondary outcomes

Stroke Impairment Assessment Set (SIAS)
Brunnstrom Stage
Functional Skills Measure After Paralysis (FSMAP)

Functional Independence Measure (FIM)
Quantified Paralysis Performance Assessment (QPPA)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The interventions for the subjects are the training with upper limb rehabilitation robot (ReoGo-J).
The frequency of the interventions for inpatients is 40 minutes a day and six times a week. The period is two weeks. The frequency of the interventions for outpatients is 40 minutes a day, two times a week. The period is six weeks. The times of all the interventions are 12 times.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients with hemiplegia in a rehabilitation ward or outpatient with hemiplegia
The general condition is stable
Patients can keep sitting
Informed-consent has been obtained

Key exclusion criteria

High-blood pressure(systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 120 mmHg or resting heart rate >= 120/min)
Restricted exercise due to heart function or respiratory function disorder
Hearing or visual impairment
Dementia or severe higher brain dysfunction

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Izumi
Middle name
Last name Kondo

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Rehabilitation medicine

Zip code

474-8511

Address

7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan

TEL

0562-46-2311

Email

ik7710@ncgg.go.jp


Public contact

Name of contact person

1st name Izumi
Middle name
Last name Kondo

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Rehabilitation medicine

Zip code

474-8511

Address

7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan

TEL

0562-46-2311

Homepage URL


Email

ik7710@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

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

National Center for Geriatrics and Gerontology

Address

7-430, Moriokachou Obu

Tel

0562-46-2311

Email

ik7710@ncgg.go.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

2018 Year 07 Month 05 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

2015 Year 08 Month 01 Day

Date of IRB

2017 Year 12 Month 07 Day

Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date

2020 Year 03 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

2018 Year 07 Month 05 Day

Last modified on

2019 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037961


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name