UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056117
Receipt number R000064120
Scientific Title Effect of Delayed Naming Initiation on Naming Training for aphasia
Date of disclosure of the study information 2025/01/18
Last modified on 2024/11/11 12:49:32

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Basic information

Public title

Effect of Delayed Naming Initiation on Naming Training for aphasia

Acronym

Effect of Delayed Naming Initiation on Naming Training for aphasia

Scientific Title

Effect of Delayed Naming Initiation on Naming Training for aphasia

Scientific Title:Acronym

Effect of Delayed Naming Initiation on Naming Training for aphasia

Region

Japan


Condition

Condition

Effect of Delayed Naming Initiation on Naming Training for aphasia

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A core symptom in persons with aphasia (PWA) is word-finding difficulty, which significantly hinders everyday conversation. In conversations with PWAs, it is recommended to wait for their verbal response when word-finding difficulty is observed. However, in cases of severe aphasia, waiting for a verbal response often does not lead to word retrieval, and the scientific basis for 'waiting for a verbal response' remains unclear. In speech-language therapy, naming training is recommended to achieve functional improvement. Recently, there has been growing interest in the influence of temporal factors on the initiation of naming during naming training. However, there is no consistent view on whether it is better to prompt naming as quickly as possible or to allow a delay before naming (Conroy et al., 2018; Martin et al., 2019; Evans et al., 2020). These studies have not sufficiently controlled for aphasia types or the severity of naming difficulties, and the time for naming initiation is often uniformly set, lacking consideration for the individuality of aphasia symptoms.
This study aims to clarify the training effect of conducting naming training with delayed naming initiation over a certain period by comparing it with standard naming training.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Error response time, correct naming counts in immediate naming training and delayed naming training (trained and untrained words)

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Individuals who provided informed consent
2. Right-handed individuals with a left cerebral hemisphere lesion due to cerebrovascular disease, diagnosed with aphasia
3. Demonstrated naming difficulties on the Standard Language Test for Aphasia (SLTA), with SLTA naming scores ranging from 15/20 to 5/20
4. No issues with intellectual functioning (within -1 standard deviation on the Raven's Colored Progressive Matrices test)
5. Currently receiving speech-language therapy (at least 40 minutes per day)
6. Aged between 20 and 75 years (the upper limit of 75 years was set to preclude suspected cognitive decline)

Key exclusion criteria

None in particular.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name tomohiro
Middle name
Last name omori

Organization

International University of Health and Welfare

Division name

Department of Speech and Hearing Sciences School of Health Sciences at Narita

Zip code

286-8686

Address

4-3 Kozunomori, Narita City Chiba

TEL

0476-28-7701

Email

tomohiroomori@iuhw.ac.jp


Public contact

Name of contact person

1st name tomohiro
Middle name
Last name omori

Organization

International University of Health and Welfare

Division name

Department of Speech and Hearing Sciences School of Health Sciences at Narita

Zip code

286-8686

Address

4-3 Kozunomori, Narita City Chiba

TEL

0476207793

Homepage URL


Email

tomohiroomori@iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

International University of Health and Welfare

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

International University of Health and Welfare

Address

4-3 Kozunomori, Narita City Chiba

Tel

0476207793

Email

tomohiroomori@iuhw.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

2025 Year 01 Month 18 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

2025 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2025 Year 01 Month 10 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None in particular


Management information

Registered date

2024 Year 11 Month 11 Day

Last modified on

2024 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064120