UMIN-ICDS Clinical Trial

Public title

A study comparing measurements obtained using two neck muscle strength devices in healthy adults

Acronym

Neck Strength Device Comparison Study

Scientific Title

Agreement and test-retest reliability of measurements obtained using two neck muscle strength measurement devices in healthy adults

Scientific Title:Acronym

Neck Strength Measurement Agreement and Reliability Study

Region

Japan

Condition

Healthy young adults

Classification by specialty

Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study aims to compare neck muscle strength measurements obtained using two different devices in healthy adults. It examines the agreement between the devices and the consistency of measurements obtained on different days. The findings are expected to provide basic evidence for comparing measurements across devices and for their potential application in swallowing function assessment.

Basic objectives2

Others

Basic objectives -Others

The objectives of this study are to evaluate the agreement between neck muscle strength measurements obtained using the Cervical Dynamometer C-1 (Anima Corporation) and the Neck Force Dynamometer T.K.K.3359 (SANKA Corporation), and to assess the test-retest reliability of each device in healthy adults. Bland-Altman analysis will be used to examine fixed and proportional biases between the devices. If systematic differences are identified, the feasibility of developing conversion equations between the devices will be explored. The findings are expected to provide fundamental evidence for the standardization of neck muscle strength assessment.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Agreement between two neck muscle strength measurement devices: Agreement between the Cervical Dynamometer C-1 and the Neck Force Dynamometer T.K.K.3359 will be evaluated using Bland-Altman analysis, including mean differences, 95% limits of agreement, fixed bias, and proportional bias.

2. Test-retest reliability of each device: Measurements obtained at baseline and 3-7 days later will be assessed using intraclass correlation coefficients (ICC) for absolute agreement with 95% confidence intervals, standard error of measurement (SEM), minimal detectable change (MDC95), and coefficient of variation.

Key secondary outcomes

Secondary outcomes include correlations between measurements obtained using the two devices, within-session reliability of three repeated measurements for each device, and relationships between devices assessed by regression analysis. The feasibility of converting measurements between devices will also be explored using Deming regression or other appropriate methods. In addition, sex-related differences in measurement trends and the effects of measurement order will be examined.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Students enrolled.
2. Individuals aged 18 years or older at the time of participation.
3. Individuals who understand the study procedures and voluntarily provide written informed consent.
4. Individuals who can understand and follow the examiner's instructions and perform cervical flexion movements.
5. Individuals who can maintain a seated position in a chair with a backrest.
6. Individuals without pain, discomfort, or physical conditions that may interfere with neck muscle strength measurements at the time of participation.

Key exclusion criteria

1. Individuals currently receiving treatment for cervical spine disorders, neurological diseases, neuromuscular diseases, or musculoskeletal disorders.
2. Individuals with a history of cervical surgery or neck injuries that may affect the measurements.
3. Individuals experiencing neck pain, shoulder pain, temporomandibular joint pain, numbness, dizziness, nausea, or other symptoms at the time of measurement.
4. Individuals diagnosed with dysphagia or those with obvious subjective symptoms of swallowing difficulties.
5. Individuals who have been advised by a physician or other healthcare professional to avoid maximal-effort muscle strength testing or cervical flexion movements.
6. Individuals who have difficulty wearing or positioning the measurement devices.
7. Individuals deemed unsuitable for safe measurement by the principal investigator or examiner.

Target sample size

55

Name of lead principal investigator

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

Email

t-sakai@paz.ac.jp

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

Institute

Gunma Paz University

Institute

Department

Personal name

Organization

Gunma Paz University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma Paz University

Address

1-7-1 Toriyamachi, Takasaki City, Gunma

Tel

0273653366

Email

t-sakai@paz.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

2026

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

06

Day

Date of IRB

2026

Year

08

Month

15

Day

Anticipated trial start date

2026

Year

09

Month

01

Day

Last follow-up date

2027

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter, prospective repeated-measures study comparing two neck muscle strength measurement devices in healthy adults. Students at Gunma Paz University will undergo measurements using the Cervical Dynamometer C-1 and the Neck Force Dynamometer T.K.K.3359. The measurement order will be randomized. Three measurements will be performed with each device, and their mean will be used for analysis. Measurements will be repeated under the same conditions 3-7 days after the initial assessment. Agreement between devices will be evaluated using Bland-Altman analysis, and test-retest reliability will be assessed using intraclass correlation coefficients (ICC). Fixed bias, proportional bias, and the feasibility of converting measurements between devices will also be examined. No therapeutic intervention will be performed.

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=R000072804