UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040578
Receipt number R000046315
Scientific Title Study on task difficulty setting for upper limb rehabilitation robot
Date of disclosure of the study information 2020/06/01
Last modified on 2021/12/01 09:57:00

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Basic information

Public title

Study on task difficulty setting for upper limb rehabilitation robot in patients with hemiplegia

Acronym

Study on task difficulty setting for upper limb rehabilitation robot

Scientific Title

Study on task difficulty setting for upper limb rehabilitation robot

Scientific Title:Acronym

Study on task difficulty setting for upper limb rehabilitation robot

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 examine the relation between the number of task achievement and the severity of paralysis, and to develop appropriate training methods through task difficulty setting for upper limb rehabilitation robot.

Basic objectives2

Others

Basic objectives -Others

Provision of appropriate training method according to characteristic of hemiplegia after stroke.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of task achievement with upper limb rehabilitation robot

Key secondary outcomes

Stroke Impairment Assessment Set (SIAS)
Fugl Meyer Assessment Scale (FMA)
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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

The intervention for the subjects are the training with upper limb rehabilitation robot (ReoGo-J).
The intervention is one time and there are 9 tasks. The evaluation is the number of each task achievement.

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 more than 180 mmHg or diastolic blood pressure more than 120 mmHg or resting heart rate more than 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

100


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

4748511

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

4748511

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

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

Tel

0562-46-2311

Email

rehab@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

2020 Year 06 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

2020 Year 05 Month 01 Day

Date of IRB

2020 Year 04 Month 17 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2025 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

By November 30, 2021, the measurements of 32 patients and 11 young healthy subjects were completed. The distribution of SIAS is 0: 0, 1: 1 and 2: 5. The number of patients was 3: 6, 4: 9, and 5:11, and there are many cases of mild motor paralysis. In the future, we would like to secure a wide range of cases, including cases with moderate to severe motor paralysis.


Management information

Registered date

2020 Year 05 Month 29 Day

Last modified on

2021 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046315


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name