UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044696
Receipt number R000051049
Scientific Title Effectiveness of N-back tasks as a new intervention strategy to promote rehabilitation effects
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/29 10:04:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effectiveness of N-back tasks as a new intervention strategy to promote rehabilitation effects

Acronym

N-back tasks

Scientific Title

Effectiveness of N-back tasks as a new intervention strategy to promote rehabilitation effects

Scientific Title:Acronym

N-back tasks

Region

Japan


Condition

Condition

stroke

Classification by specialty

Neurology Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to perform an N-back task in patients with acute stroke before performing rehabilitation, evaluate the effect by cognitive function, upper limb function, and activities of daily living, and to improve the conditioning effect of the brain. It is to verify the usefulness.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fugl Meyer Assessment Set
(Evaluate immediately after the start of intervention and re-evaluate at the final evaluation)

Key secondary outcomes

Near infrared spectroscopy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

N-back task

Interventions/Control_2

control

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1 Patients with mild to moderate motor paralysis in one upper limb due to initial cerebral infarction
2 Patients who can hold a sitting position

Key exclusion criteria

1 Patients with impaired consciousness
2 Patients with dementia or intellectual disability who have difficulty understanding aphasia or N-back issues

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Wataru
Middle name
Last name Mitsunaga

Organization

Nagasaki University Hospital

Division name

Rehabilitation department

Zip code

852-8102

Address

1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture

TEL

095-819-7200

Email

wataru-mitsunaga@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Wataru
Middle name
Last name Mitsunaga

Organization

Nagasaki University Hospital

Division name

Rehabilitation department

Zip code

8528102

Address

1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture

TEL

095-819-7200

Homepage URL


Email

wataru-mitsunaga@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital

Address

1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture

Tel

095-819-7200

Email

wataru-mitsunaga@nagasaki-u.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

2021 Year 07 Month 01 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

Preinitiation

Date of protocol fixation

2021 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2021 Year 09 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 29 Day

Last modified on

2021 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name