UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000063610
Receipt number	R000072800
Scientific Title	Intrarater reliability of neck flexor strength measurement using a hand-held dynamometer and its relationships with tongue pressure and isometric head-lift hold time: a preliminary study in healthy young adults
Date of disclosure of the study information	2026/11/12
Last modified on	2026/11/12 20:10:46

* 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

Intrarater reliability of neck flexor strength measurement using a hand-held dynamometer and its relationships with tongue pressure and isometric head-lift hold time: a preliminary study in healthy young adults

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Young healthy adults

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The suprahyoid muscles involved in swallowing are known to exhibit age-related functional decline, which may increase the risk of aspiration pneumonia. However, few methods are available for easily and quantitatively assessing swallowing-related muscle strength in clinical settings. This study aimed to evaluate the intra-rater reliability of cervical flexion strength measurement using a hand-held dynamometer (HHD) with a cervical attachment, and to examine its associations with tongue pressure and cervical flexion endurance time in healthy young adults, thereby clarifying the fundamental characteristics of this measurement method.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Cervical flexion strength, tongue pressure measurement, and maximum endurance time of an isometric cervical flexion posture.

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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

The study participants were healthy young adult students who received sufficient written and verbal explanations of the study's purpose and procedures, as well as the measures taken to protect their personal information, prior to the start of the study, and who provided written informed consent to participate voluntarily.

Key exclusion criteria

Individuals with a history of cervical disorders, neuromuscular diseases, or dysphagia; those with neck pain or restricted cervical movement; and those deemed unsuitable for participation by the principal investigator.

Target sample size

Research contact person

Name of lead principal investigator

1st name TETSURO

Middle name

Last name SAKAI

Organization

Gunma Paz University

Division name

Department of Speech-Language-Hearing Therapy, Faculty of Rehabilitation,

Zip code

3700006

Address

1-7-1 Toriyamachi, Takasaki City, Gunma

TEL

027-365-3366

Email

t-sakai@paz.ac.jp

Public contact

Name of contact person

1st name TETSURO

Middle name

Last name SAKAI

Organization

Gunma Paz University

Division name

Faculty of Rehabilitation Department of Speech-Language-Hearing Sciences

Zip code

3700006

Address

1-7-1 Toriyamachi, Takasaki City, Gunma

TEL

0273653366

Homepage URL

Email

t-sakai@paz.ac.jp

Sponsor or person

Institute

Gunma Paz University

Institute

Department

Personal name

Funding Source

Organization

Gunma Paz University

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

Gunma Paz University

Address

1-7-1 Toriyamachi, Takasaki City, Gunma

Tel

027-365-3366

Email

t-sakai@paz.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2026 Year 11 Month 12 Day

Related information

URL releasing protocol

The study protocol is not publicly available.

Publication of results

Published

Result

URL related to results and publications

now printting

Number of participants that the trial has enrolled

Results

In 31 healthy young adults, intra-rater reliability was high for neck flexor strength (ICC [1,1] = 0.98, 95% CI: 0.95-0.98) and tongue pressure (ICC [1,1] = 0.93, 95% CI: 0.85-0.96). Neck flexor strength showed moderate positive correlations with tongue pressure (r = 0.448, p < 0.05) and head-lift hold time (rs = 0.494, p < 0.01).

Results date posted

2026 Year 11 Month 12 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

A total of 31 healthy young adults (11 males and 20 females) participated in this study. The mean age was 23.8 +/- 7.06 years. The mean neck flexor strength was 15.4 +/- 5.31 kgf, maximum tongue pressure was 44.7 +/- 9.72 kPa, and maximum isometric head-lift hold time was 151.4 +/- 75.11 seconds. All values are presented as mean +/- standard deviation. Screening using the Seirei Swallowing Questionnaire revealed no symptoms suggestive of dysphagia in any participant.

Participant flow

A total of 31 healthy young adults (11 males and 20 females) provided written informed consent and participated in the study. Screening using the Seirei Swallowing Questionnaire identified no participants who met the exclusion criteria. All 31 participants underwent measurements of neck flexor strength, maximum tongue pressure, and maximum isometric head-lift hold time. All 31 participants were included in the final analysis.

Adverse events

No adverse events related to the study measurements were observed.

Outcome measures

The primary outcome measure was the intra-rater reliability of neck flexor strength measurement using a hand-held dynamometer (HHD), assessed by the intraclass correlation coefficient (ICC [1,1]) and its 95% confidence interval (CI). The intra-rater reliability of maximum tongue pressure measurement was also evaluated. In addition, associations between neck flexor strength and maximum tongue pressure and maximum isometric head-lift hold time were examined using Pearson's or Spearman's correlation coefficients.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2023 Year 06 Month 29 Day

Date of IRB

2023 Year 09 Month 23 Day

Anticipated trial start date

2023 Year 09 Month 23 Day

Last follow-up date

2023 Year 12 Month 23 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

This study is a cross-sectional observational study involving healthy young adults. It aims to evaluate the intra-rater reliability of cervical flexion strength measurements using a hand-held dynamometer (HHD) with a cervical attachment and to examine the associations among cervical flexion strength, tongue pressure, and maximum endurance time of an isometric cervical flexion posture. No therapeutic intervention will be performed.

Management information

Registered date

2026 Year 11 Month 12 Day

Last modified on

2026 Year 11 Month 12 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072800