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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016799
Receipt No. 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

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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
Institute Univeristy of Occupational and Environmental Health
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019373

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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