Tokyo, Nov. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061644) titled 'Development and Usability Evaluation of a Novel Pneumatic Digital Hand Dynamometer' on Nov. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Okayama University Hospital

Condition: Condition - Examiners performing handgrip strength measurements in clinical settings (Physical Therapists, Occupational Therapists) Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 22 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 Size - 16

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 25 Day Anticipated trial start date - 2026 Year 07 Month 30 Day Last follow-up date - 2026 Year 08 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070532

Disclaimer: Curated by HT Syndication.