UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040706
Receipt number R000046468
Scientific Title The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients
Date of disclosure of the study information 2020/06/10
Last modified on 2020/12/19 14:58:23

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Basic information

Public title

The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients

Acronym

The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients

Scientific Title

The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients

Scientific Title:Acronym

The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients

Region

Japan


Condition

Condition

Home Stroke Patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effect of cognitive neurological rehabilitation on upper limb function in home stroke patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fugl-Meyer Assessment upper limb
Motor Activity Log

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

cognitive neuro-rehabilitation

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Home stroke patients undergoing outpatient rehabilitation at our hospital

Key exclusion criteria

Students who have scored less than 24 points on the Mini-Mental State Examination.
A person who presents with severe higher brain function
Those with Central Post Stroke Pain
Those who are unable to give consent to participate in this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Nakagawa
Middle name
Last name Kotaro

Organization

Kawaguchi Neurosurgery Rehabilitation Clinic

Division name

Department of Rehabilitation

Zip code

5730086

Address

9-25-202 Korizono-cho, Hirakata City, Osaka

TEL

0728351010

Email

kawaguchi.ns.reha@gmail.com


Public contact

Name of contact person

1st name Iki
Middle name
Last name Shinya

Organization

Kawaguchi Neurosurgery Rehabilitation Clinic

Division name

Department of Rehabilitation

Zip code

5730086

Address

9-25-202 Korizono-cho, Hirakata City, Osaka

TEL

0728351010

Homepage URL

https://kawaguchi-ns.com/

Email

kawaguchi.ns.reha@gmail.com


Sponsor or person

Institute

Kawaguchi Neurosurgery Rehabilitation Clinic

Institute

Department

Personal name



Funding Source

Organization

none

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

Kawaguchi Neurosurgery Rehabilitation Clinic

Address

9-25-202 Korizono-cho, Hirakata City, Osaka

Tel

0728351010

Email

kawaguchi.ns.reha@gmail.com


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 06 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

8

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

2020 Year 02 Month 21 Day

Date of IRB

2020 Year 02 Month 21 Day

Anticipated trial start date

2020 Year 02 Month 21 Day

Last follow-up date

2020 Year 12 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 09 Day

Last modified on

2020 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name