UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061644 |
|---|---|
| Receipt number | R000070532 |
| Scientific Title | Development and Usability Evaluation of a Novel Pneumatic Digital Hand Dynamometer: An Exploratory Clinical Study Comparing with a Mercury Hand Dynamometer |
| Date of disclosure of the study information | 2026/11/15 |
| Last modified on | 2026/05/20 20:07:43 |
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Basic information
Public title
Development and Usability Evaluation of a Novel Pneumatic Digital Hand Dynamometer
Acronym
Pneumatic Digital Hand Dynamometer Usability Study
Scientific Title
Development and Usability Evaluation of a Novel Pneumatic Digital Hand Dynamometer: An Exploratory Clinical Study Comparing with a Mercury Hand Dynamometer
Scientific Title:Acronym
Pneumatic Digital Hand Dynamometer Clinical Trial
Region
| Japan |
Condition
Condition
Examiners performing handgrip strength measurements in clinical settings (Physical Therapists, Occupational Therapists)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on the automatic pre-pressurization feature of a newly developed pneumatic digital hand dynamometer. It aims to evaluate its clinical usability by comparing it with a conventional manual mercury hand dynamometer to determine whether it significantly shortens pre-pressurization time and reduces examiners' subjective workload and psychological stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-pressurization time (seconds) required to set the cuff pressure to 20 mmHg
Method: The time from the start signal until the cuff pressure reaches the specified pre-pressurization level (20 mmHg) and stabilizes is measured using a stopwatch via visual confirmation (mercury column or digital display).
Key secondary outcomes
Examiners' subjective workload and psychological margins (evaluated by a 7-point Likert scale)
Domains: 1) Psychological burden such as keeping the patient waiting; 2) Physical burden involved in the series of pre-pressurization steps; 3) Safety-monitoring burden such as keeping an eye on the patient; 4) Margin for communication/conversation time with the patient.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
In a randomized crossover design (within-subject comparison), each participant performs the pre-pressurization operation once under the following two conditions:
1.Conventional device condition: The cuff pressure is inflated to 20 mmHg using a manual pump (rubber bulb), and finely adjusted manually while visually monitoring the mercury column.
2.New device condition: The cuff pressure is automatically set to 20 mmHg via button operation using the automatic pre-pressurization feature of the pneumatic digital hand dynamometer.
In both conditions, the time required to reach and stabilize at the specified pressure (20 mmHg) is measured as the primary outcome. Immediately after the procedures, a questionnaire survey (7-point Likert scale) regarding subjective workload is administered.
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Physical therapists or occupational therapists currently working at the host institution who have clinical experience and proficiency in using mercury hand dynamometers.
2 Possess adequate visual acuity (including corrected vision) to accurately read the mercury column scale, and sufficient hand function to smoothly perform manual pump inflation.
3 Capable of fully understanding the study details and providing voluntary written informed consent.
Key exclusion criteria
1 Individuals with self-reported acute pain, inflammation, or severe range of motion restriction in the fingers, wrist, or elbow (e.g., tenosynovitis, carpal tunnel syndrome, trauma) that hinders the operation of standard dynamometers.
2 Individuals with visual impairment that precludes accurate reading of the mercury column even with correction.
3 Individuals directly involved in the development of the new device in the past, where potential evaluation bias may occur.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Horita |
Organization
Okayama University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan
TEL
086-235-7752
masahiro.horita@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Fujioka |
Organization
Okayama University Hospital
Division name
Department of Comprehensive Rehabilitation
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan
TEL
086-235-7752
Homepage URL
fjfj1234321@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan
Tel
086-235-6536
rinri@adm.okayama-u.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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 15 | 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
| 2026 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 20 | Day |
Last modified on
| 2026 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070532
