UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016799
Receipt number R000019373
Scientific Title Clinical study on improvement of upper extremity function in hemiplegic patients in the chronic stage with a simple training-assistance robot
Date of disclosure of the study information 2015/03/15
Last modified on 2019/03/08 17:07:23

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Basic information

Public title

Clinical study on improvement of upper extremity function in hemiplegic patients in the chronic stage with a simple training-assistance robot

Acronym

Clinical study on improvement of the upper extremity function with MA2

Scientific Title

Clinical study on improvement of upper extremity function in hemiplegic patients in the chronic stage with a simple training-assistance robot

Scientific Title:Acronym

Clinical study on improvement of the upper extremity function with MA2

Region

Japan


Condition

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim is to reveal whether a simple training-assistance robot improves the upper extremity function in hemiplegic patients in the chronic stage

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fugl-Meyer Assessment, Modified Ashworth Scale

Key secondary outcomes

Range of motion, Motor Activity Log, Stroke Impact Scale, Burden of training


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

THe robot group undergoes a 20-minute session of upper extremity training per day, 2 sessions per week, for 12 weeks, 24 sessions in total.

Interventions/Control_2

The control group undergoes a 20-minute session of usual care including group exercises 2 sessions per week, for 12 weeks, 24 sessions in total.

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

40 years-old <=

Age-upper limit

89 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Stroke hemiplegic patients
2)Six or more than 6 months since the onset
3)Brunnstrom recovery stage for the upper extremity III, IV or V
4)Understand the purpose of this MA2-assisted training
5)Agree to join the study voluntarily

Key exclusion criteria

1)Bilateral hemiplegia
2)Main symptom is ataxia, rigidity or sensory disturbance
3)Severe speech disturbance
4)Dementia
5)Neurological diseases affecting MA2-assisted training except hemiplegia
6)Cardio-respiratory disease affecting MA2-assisted training
7)Musculoskeletal diseases affecting MA2-assisted training

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Hachisuka

Organization

Moji Medical Center, Kyushu Rosai Hospital, Japn Labour Health and Welfare Organization

Division name

Director Room

Zip code


Address

3-1 Higashiminatomachi, Moji-ku, Kitakyushu

TEL

093-331-3461

Email

khachi@mojih.rofuku.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Ono

Organization

University of Occupational and Environmental Health

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu

TEL

093-691-7266

Homepage URL


Email

ono-a@med.uoeh-u.ac.jp


Sponsor or person

Institute

Univeristy of Occupational and Environmental Health

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Scinece and Culture

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


Address


Tel


Email



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

2015 Year 03 Month 15 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

2014 Year 11 Month 26 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 04 Month 30 Day

Date trial data considered complete

2017 Year 07 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 03 Month 14 Day

Last modified on

2019 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019373