UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study examining appropriate training program using ReoGo-J for the upper limb function after paralysis after stroke
Acronym	A prospective observational study examining appropriate training program using ReoGo-J
Scientific Title	A prospective observational study examining appropriate training program using ReoGo-J for the upper limb function after paralysis after stroke
Scientific Title:Acronym	A prospective observational study examining appropriate training program using ReoGo-J
Region	Japan

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

Objectives
Narrative objectives1	To examine a standard program for ReoGo-J training, which does not depend on the therapist's experience and skills, but is appropriate for upper limb function, each ReoGo-J training was conducted for stroke patients with paralyzed upper limbs. The difficulty of each ReoGo-J training and the ability value of the patient are estimated by evaluating the QOM (Quality of Movement) of the item and applying the item response theory to the score.
Basic objectives2	Others
Basic objectives -Others	From the QOM for a small number of ReoGo-J training items, a model that estimates a training menu suitable for the patient is constructed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOM (Quality of Movement) of MAL (Motor Activity Log) in ReoGo-J test
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Stroke patients with hemiplegic upper limbs (2) Patients who are or are planning to use ReoGo-J for training (3) Patients more than 2 weeks after onset or more than 3 days after admission to convalescent ward (4) Patients aged 20 years or older at the time of obtaining consent (5) Patients who obtained written informed consent for participation in this study
Key exclusion criteria	(1) Cerebellar / brain stem stroke patients (2) Patients with severe aphasia or higher brain dysfunction (3) Patients with extreme upper limb pain (4) Patients who cannot make clear decisions (5) Patients who have already been registered in this study (6) Other patients who were judged inappropriate by the physician in charge of this study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Uchiyama
Organization	Hyogo Medical College
Division name	Department of Rehabilitation Medicine
Zip code	663-8501
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6881
Email	yutti@hyo-med.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Uchiyama
Organization	Hyogo College of Medicine
Division name	Department of Rehabilitation Medicine
Zip code	663-8501
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
TEL	0798-45-6881
Homepage URL
Email	yutti@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Teijin Pharma limited.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee, Hyogo College of Medicine
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo
Tel	0798-45-6066
Email	rinri@hyo-med.ac.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 04 Month 10 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	Open public recruiting
Date of protocol fixation	2020 Year 03 Month 03 Day
Date of IRB	2020 Year 03 Month 03 Day
Anticipated trial start date	2020 Year 04 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2020 Year 04 Month 10 Day
Last modified on	2020 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045755