UMIN-CTR Clinical Trial

Public title

Establishment of Evidence based swallowing rehabilitation

Acronym

Establishment of Evidence based swallowing rehabilitation

Scientific Title

Establishment of Evidence based swallowing rehabilitation

Scientific Title:Acronym

Establishment of Evidence based swallowing rehabilitation

Region

Japan

Condition

dysphagia

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To establish high evidences for swallowing rehabilitation

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Penetration aspiration score

Key secondary outcomes

Hyodo score
FOIS

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

patients undergo traditional and the purpose training

Interventions/Control_2

patients undergo traditional training

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patient with aspiration pneumonia or patient with high risk of aspiration pneumonia

Key exclusion criteria

patients whose primary illness are uncontrolled

Target sample size

40

Name of lead principal investigator

1st name	Omori
Middle name
Last name	Koichi

Organization

Kyoto University

Division name

Depart. of otolaryngology-head and neck surgery

Zip code

606-8507

Address

54 Kawaharachou, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3346

Email

omori@ent.kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Atsushi
Middle name
Last name	Suehiro

Organization

Kyoto University

Division name

Depart. of otolaryngology-head and neck surgery

Zip code

606-8507

Address

54 Kawaharachou, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3346

Homepage URL

Email

a_suehiro@ent.kuhp.kyoto-u.ac.jp

Institute

AMED

Institute

Department

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

54 Kawaharachou, Shogoin, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

01

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000034894

Publication of results

Unpublished

URL related to results and publications

N/A

Number of participants that the trial has enrolled

40

Results

Recruitment currently suspended due to COVID19 infection outbreak

Results date posted

2022

Year

06

Month

30

Day

Results Delayed

Delay expected

Results Delay Reason

Recruitment currently suspended due to COVID19 infection outbreak

Date of the first journal publication of results

Baseline Characteristics

Patients with aspiration 20 patients in each group (40 total)　
Chronic disease
Experimental group: Only the training method under study
Control group: Traditional training methods only

Participant flow

Request for swallowing training from the main department to the rehabilitation department
Determination of the appropriateness of swallowing training (principal investigator, speech-language pathologist in charge of rehabilitation)
Explanation to patients and their families and obtaining of consent
Registration, contact to the principal investigator, and determination of the indication for participation in the study
Allocation of patients (randomization by principal investigator)

Adverse events

Although the swallowing training in this study is a widely used technique, aspiration pneumonia may be prolonged due to the progression of the underlying disease or inadequate swallowing rehabilitation.

Outcome measures

Penetration aspiration scale (PAS) (during fluoroscopy (VF))
Hyodo score (during endoscopy (VE))
Scoring of the above two items was based on the median value of the video images checked by multiple researchers.
Evaluators are physicians from the Department of Otorhinolaryngology and Head and Neck Surgery, Kyoto University
FOIS score (Dietary pattern)

Plan to share IPD

IPD sharing Plan description

Recruitment status

Suspended

Date of protocol fixation

2018

Year

04

Month

01

Day

Date of IRB

2018

Year

04

Month

26

Day

Anticipated trial start date

2018

Year

04

Month

01

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 related information

Registered date

2017

Year

12

Month

26

Day

Last modified on

2023

Year

12

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034894