UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040127
Receipt number R000045755
Scientific Title A prospective observational study examining appropriate training program using ReoGo-J for the upper limb function after paralysis after stroke
Date of disclosure of the study information 2020/04/10
Last modified on 2020/04/23 18:00:41

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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 or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045755


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name