UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design]
Acronym	Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design]
Scientific Title	Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design]
Scientific Title:Acronym	Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design]
Region	Japan

Condition
Condition	stroke
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness of voluntary training with TV game for the upper paretic arm in patients with post-stroke hemiparesis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wolf moter function test(WMFT)
Key secondary outcomes	Fugl-Meyer Assessment (FMA), Action Research Arm Test (ARAT), Box and Block test(BBT) range of motion (ROM)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Voluntary upper limb training using video game machines
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	upper limb Br. S 3, 4 or 5 1) Upper paretic extremity after a new, single stroke 2) Unilateral cerebral hemisphere stoke 3) Within 6 months from the onset of stroke, 4) Brunnstrom stage in upper extremity scored 3, 4 or 5 5) Ability to sit on the chair for 15 min
Key exclusion criteria	1)Patients who can not voluntarily train 2) Severe arm contracure 3) Severe arm pain 4) Anesthesia at arm 5) Aphasic, perceptual, apraxic, or cognitive deficits that would prevent adequate study participation 6) Inability to provide informed consent
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Ueno
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Rehabilitation Medicine and Physical Medicine
Zip code
Address	8-35-1, Sakuragaoka, Kagoshima-city, Kagoshima
TEL	0992755339
Email	m-k-t-u@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ueno Makoto
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Rehabilitation Medicine and Physical Medicine
Zip code
Address	8-35-1, Sakuragaoka, Kagoshima-city, Kagoshima
TEL	0992755339
Homepage URL
Email	m-k-t-u@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Hospital
Institute
Department

Funding Source
Organization	Kagoshima University
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
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	2018 Year 03 Month 06 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	2017 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 06 Day
Last modified on	2018 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036092

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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