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Assessing the Feasibility of a Novel Dynamometry Protocol for Measuring Finger Extensor Strength

27. července 2026 aktualizováno: Boston University Charles River Campus

This study aims to evaluate the feasibility and reliability of a novel method for assessing finger extension strength using an adapted dynamometer, addressing the limitation of current hand grasp assessment protocols that focus only on finger flexor muscles. The study will recruit able-bodied adult participants, and a force gauge will be used to obtain precise measures of the strength of their extensor digitorum muscles.

Participants will be seated with their upper extremity supported on an adjustable table and have a force gauge, connected to a custom-made support positioned around their proximal phalanx. The support will be connected to a force gauge, which will measure participants' extensor muscles strength in Newtons (N). To assess the feasibility and reliability of this new setup, three measurements will be collected for each hand, with a one-minute interval between each measurement and a 5-minute break between evaluators, with the order randomized to reduce bias.

The study will recruit participants from BU's Sargent College of Health and Rehabilitation Sciences and will be conducted by independent evaluators trained in muscle assessment and clinical evaluation of the hand and upper extremities. The total participation time should not exceed 30 minutes per participant.

The primary hypothesis is that this novel and accessible device can provide accurate and reliable measurements of participants' finger extensor muscles' strength. Results from this study could have important implications for hand rehabilitation and therapy, particularly for individuals with hand dysfunction due to musculoskeletal disorders or injuries.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

The purpose of this observational study is to measure the strength of independent finger extension for the four middle digits (II-V). Independent extension involves actively extending one finger while keeping the other fingers fully flexed, while dependent extension involves actively extending all the fingers, including the index finger. The study protocol is based on a previous study (Matter-Parrat et al., 2017), where researchers used a similar device to compare dependent and independent finger extension. However, in contrast to the previous study, this study aims to measure extension forces for all fingers, not just the index finger.

To achieve this, the tests will be performed three times, on both hands, by three examiners and compared to determine the intra-examiner reproducibility and the inter-examiner reproducibility. The investigators will measure all fingers on participants' dominant hand first, following by their non-dominant hand. This sequence will be repeated three times for each evaluator. A five-minute interval will be stablished between each evaluator, as well as 1-minute break between each attempt, to minimize the risk of muscle fatigue.

During the test procedures, the participants' upper extremity will be positioned over a height-adjustable table, which will be placed on the side of the participant. This will allow for optimal support and stability during the measurement of finger extension strength. The height of the table will be adjusted to ensure that the participant's shoulder is in abduction, and their elbows are at a 90-degree angle of flexion. The forearms will be placed in a pronated position, while the wrists and metacarpophalangeal joints will be maintained in a neutral position to prevent any unwanted movement during the test. The participants will be seated comfortably with their back supported by a chair with no armrests to avoid any interference with the test procedures. In case active extension of the wrist is observed by an elevation of the metacarpal heads from the stand, the test will be repeated to obtain isolated extension of the fingers.

To measure participants' finger extension strength, a 3D printed support was specifically designed and printed in PLA (Polylactic Acid) on an ENDER 3 printer. Additionally, PLA is a suitable material that can be easily disinfected with 70% ethanol, maintaining hygiene standards between participants. We will print several scaled models of the support, ensuring the support can be tailored to best fit participants' hands. We will select the support whose size comfortably accommodate the dorsum of the participant's proximal phalanx, providing a secure and ergonomic fit. Once the support is connected to the force gauge's M6 Metric attachments, participants will be asked to extend each finger independently as forcefully as possible while keeping the other fingers in full flexion.

Data will be obtained by recording the peak value using the Baoshishan 500N force gauge, a commercially available device used to measure the strength of extensor digitorum muscles. The device, manufactured by Baoshishan Instrument Co., Ltd, China, has a measuring range of 0-500N (0-112.4 lbf) and an accuracy of ±0.5% of full scale. It features a resolution of 0.1N (0.0225 lbf) and a sampling frequency of 2000Hz. The gauge has a large, easy-to-read LCD display that shows force values in Newtons (N) or pounds (lbf). The device is compact and lightweight, measuring 170 x 86 x 38 mm and weighing 0.5 kg. Safety precautions will be followed to ensure participant well-being, including proper handling of the device, avoiding damage to internal components, and keeping it away from water and other liquids. The rechargeable battery will be charged according to the manufacturer's instructions, and the device will be stored in a dry, cool place when not in use.

All data analysis procedures will be performed using SPSS version 27.0 (IBM Corp., Armonk, NY, USA). Continuous data will be presented as mean ± standard deviation, and categorical data will be presented as numbers and percentages. The normality of the distribution will be assessed using the Shapiro-Wilk test and graphically. For all statistical analyses, a significance level of 0.05 will be considered, and confidence intervals will be reported where appropriate.

To assess the reproducibility of the measurements, the intra-class correlation coefficient (ICC) will be calculated. The confidence interval for the ICC will be determined using the bootstrap method with 10,000 replicates. An F-test will be performed to determine if the ICC significantly differs from zero, indicating nil reproducibility. Good intra-examiner and inter-examiner reproducibility will be defined as ICC values above 0.90 and 0.75, respectively.

Mixed linear regression models will be used to compare extension strength between the dominant and non-dominant hands, incorporating a 'subject' random effect to account for within-subject correlation. This analysis will allow us to examine potential differences in finger extension strength between the hands while considering individual variation.

Typ studie

Pozorovací

Zápis (Aktuální)

50

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02215
        • Boston University - Department of Occupational Therapy

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

This study will invite a convenience sample of 50 English-speaking adults with no existing medical condition affecting the motor performance of their upper extremities, such as fractures, joint stiffness, neurological, rheumatological, or musculoskeletal conditions

Popis

Inclusion Criteria:

English-speaking adults No diagnosis or history of conditions affecting their upper extremities mobility.

Exclusion Criteria:

Current or past history of neurologic, rheumatologic, or orthopedic disorders impacting physical performance; A current disorder affecting cognition; Visual, tactile, or perceptual deficits that could prevent full participation in the study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Finger extensor - muscle force
Časové okno: 1 hour
Muscle force generated by participant's extensor digitorum muscles (both hands), measured in Newtons.
1 hour

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Pedro Almeida, PhD, Boston University - Department of Occupational Therapy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. srpna 2023

Primární dokončení (Aktuální)

30. listopadu 2023

Dokončení studie (Aktuální)

31. prosince 2023

Termíny zápisu do studia

První předloženo

10. října 2023

První předloženo, které splnilo kritéria kontroly kvality

27. července 2026

První zveřejněno (Aktuální)

28. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. července 2026

Naposledy ověřeno

1. října 2023

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 7053E

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .