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

2026年7月27日 更新者: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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

観察的

入学 (実際)

50

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • Boston University - Department of Occupational Therapy

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Finger extensor - muscle force
時間枠:1 hour
Muscle force generated by participant's extensor digitorum muscles (both hands), measured in Newtons.
1 hour

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Pedro Almeida, PhD、Boston University - Department of Occupational Therapy

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年8月1日

一次修了 (実際)

2023年11月30日

研究の完了 (実際)

2023年12月31日

試験登録日

最初に提出

2023年10月10日

QC基準を満たした最初の提出物

2026年7月27日

最初の投稿 (実際)

2026年7月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月28日

QC基準を満たした最後の更新が送信されました

2026年7月27日

最終確認日

2023年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 7053E

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