UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000055465
Receipt number R000063378
Scientific Title Effects on cerebral haemodynamics during verbal fluency tasks before and after left-shift prism adaptation
Date of disclosure of the study information 2024/09/09
Last modified on 2024/09/09 17:27:42

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Basic information

Public title

Effects on cerebral haemodynamics during verbal fluency tasks before and after left-shift prism adaptation

Acronym

Effects on cerebral haemodynamics during verbal fluency tasks before and after left-shift prism adaptation

Scientific Title

Effects on cerebral haemodynamics during verbal fluency tasks before and after left-shift prism adaptation

Scientific Title:Acronym

Effects on cerebral haemodynamics during verbal fluency tasks before and after left-shift prism adaptation

Region

Japan


Condition

Condition

healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to determine whether changes in cerebral haemodynamics occurred before and after prismatic adaptation to left shift by performing a verbal fluency task.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Linguistic fluency tasks
Oxy-Hb
Manual Straight Ahead

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Task of wearing prism glasses shifted to the left and repeating the reaching motion to the target 80 times.

Interventions/Control_2

The task is to wear prism glasses shifted to the right and repeat the action of reaching for the target 80 times.

Interventions/Control_3

Task of 80 repetitions of reaching movements to the target wearing unbiased spectacles.

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

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Right-handed healthy adults.

Key exclusion criteria

Significant musculoskeletal impairment with limited range of motion in the upper limb
History of cerebrovascular disease.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Matsuo

Organization

Kumamoto Health Science University

Division name

Department of Rehabilitation

Zip code

861

Address

325 Izumi-machi,kita-ku,kumamoto japan

TEL

09029699212

Email

m.takashi0627@gmail.com


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Matsuo

Organization

Kumamoto Health Science University

Division name

Department of Rehabilitation

Zip code

8615598

Address

325 Izumimachi,Kitaku,Kumamoto to city,Japan

TEL

0962752111

Homepage URL


Email

matsuo-ta@kumamoto-hsu.ac.jp


Sponsor or person

Institute

Kumamoto Health Sciences University

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kumamoto health Science university

Address

325 Izumi-machi, kita-ku, kumamoto

Tel

09029699212

Email

m.takashi0627@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

熊本保健科学大学


Other administrative information

Date of disclosure of the study information

2024 Year 09 Month 09 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

2024 Year 08 Month 12 Day

Date of IRB

2024 Year 09 Month 02 Day

Anticipated trial start date

2024 Year 09 Month 09 Day

Last follow-up date

2026 Year 03 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

2024 Year 09 Month 09 Day

Last modified on

2024 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063378