UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on improvement of upper extremity function in hemiplegic patients in the chronic stage with a simple training-assistance robot
Title of the study (Brief title)	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	Kenji Hachisuka
Organization	Moji Medical Center, Kyushu Rosai Hospital, Japn Labour Health and Welfare Organization
Division name	Director Room
Address	3-1 Higashiminatomachi, Moji-ku, Kitakyushu
TEL	093-331-3461
Email	khachi@mojih.rofuku.go.jp

Public contact
Name of contact person	Akiko Ono
Organization	University of Occupational and Environmental Health
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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