Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque

NCT ID: NCT05109871

Last Updated: 2025-05-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-08-02

Brief Summary

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This study will investigate the reliability and validity of an inline 'pull-type' dynamometer for measuring peak knee extensor torque. For the reliability study, healthy volunteers will be assessed by two assessors (inter-rater) at the index testing session, with testing repeated by one assessor one week later (test-retest). Validity will be investigated against isometric electromechanical dynamometry (gold standard) in patients following anterior cruciate ligament (ACL) reconstruction.

Detailed Description

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This is a prospective, cross sectional study using a within-participant, repeated measures design. The inter-rater and test-retest reliability of the KForce Link (pull-type dynamometer) will be determine using 50 healthy subjects. The validity of the KForce Link will be determined using 52 post-operative ACL reconstruction patients against the gold standard of isometric electromechanical dynamometry (Cybex). All testing will be performed isometrically with the knee positioned at 60 degrees knee flexion. Assessors and participants will be blinded to the scores until testing is complete.

Conditions

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Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Kforce Link

Group Type EXPERIMENTAL

KForce Link

Intervention Type OTHER

Traction (pull-type) dynamometer

Interventions

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KForce Link

Traction (pull-type) dynamometer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.

Exclusion Criteria

* For the ACL reconstruction participant cohort: diagnosed with ACL injury that was managed with ACL reconstruction surgery, with or without additional meniscal surgery. If medicated, stable dose of current regular medication for at least 4 weeks prior to study entry.
* For the healthy control participant cohort: no current or previous history of significant lower limb injury, or a history of previous minor injury that is symptomatic at the time of recruitment. No previous lower limb surgery. No course of medication, whether prescribed or over the counter, other than vitamins and mineral supplements or, for females, oral contraceptives.


* Unable to provide written consent to study participation, or there are contraindications to maximal force testing, including the following:

* History of chronic disease or disorder that may put the participants at risk because of participation in the study including non-united fractures, epilepsy, cardiac insufficiency, severe peripheral vascular disease, aneurysms, anticoagulant therapy, recent (\<3 months) radiotherapy or chemotherapy, long term steroid use (\>3 months), pregnancy, neurological disorders (e.g., Parkinson's disease), skin conditions at point of force testing, severe osteoporosis, malignancy, rheumatoid arthritis.
* Conditions or symptoms that may influence the result of the study, or the participant's ability to participate in the study including pain, limited range of motion, knee effusion, or anaemia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Norris, BSc

Role: PRINCIPAL_INVESTIGATOR

Aintree University Hospital

Locations

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Aintree University Hospital

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

References

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Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.

Reference Type BACKGROUND
PMID: 21570036 (View on PubMed)

Whiteley R, Jacobsen P, Prior S, Skazalski C, Otten R, Johnson A. Correlation of isokinetic and novel hand-held dynamometry measures of knee flexion and extension strength testing. J Sci Med Sport. 2012 Sep;15(5):444-50. doi: 10.1016/j.jsams.2012.01.003. Epub 2012 Mar 15.

Reference Type BACKGROUND
PMID: 22424705 (View on PubMed)

Bohannon RW, Bubela DJ, Wang YC, Magasi SR, Gershon RC. Adequacy of belt-stabilized testing of knee extension strength. J Strength Cond Res. 2011 Jul;25(7):1963-7. doi: 10.1519/JSC.0b013e3181e4f5ce.

Reference Type BACKGROUND
PMID: 21399535 (View on PubMed)

Kelln BM, McKeon PO, Gontkof LM, Hertel J. Hand-held dynamometry: reliability of lower extremity muscle testing in healthy, physically active,young adults. J Sport Rehabil. 2008 May;17(2):160-70. doi: 10.1123/jsr.17.2.160.

Reference Type BACKGROUND
PMID: 18515915 (View on PubMed)

Hansen EM, McCartney CN, Sweeney RS, Palimenio MR, Grindstaff TL. Hand-held Dynamometer Positioning Impacts Discomfort During Quadriceps Strength Testing: A Validity and Reliability Study. Int J Sports Phys Ther. 2015 Feb;10(1):62-8.

Reference Type BACKGROUND
PMID: 25709864 (View on PubMed)

Sinacore JA, Evans AM, Lynch BN, Joreitz RE, Irrgang JJ, Lynch AD. Diagnostic Accuracy of Handheld Dynamometry and 1-Repetition-Maximum Tests for Identifying Meaningful Quadriceps Strength Asymmetries. J Orthop Sports Phys Ther. 2017 Feb;47(2):97-107. doi: 10.2519/jospt.2017.6651.

Reference Type BACKGROUND
PMID: 28142362 (View on PubMed)

Almeida GPL, Albano TR, Melo AKP. Hand-held dynamometer identifies asymmetries in torque of the quadriceps muscle after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2019 Aug;27(8):2494-2501. doi: 10.1007/s00167-018-5245-3. Epub 2018 Oct 30.

Reference Type BACKGROUND
PMID: 30377716 (View on PubMed)

Suzuki T. Reliability of measurements of knee extensor muscle strength using a pull-type hand-held dynamometer. J Phys Ther Sci. 2015 Mar;27(3):967-71. doi: 10.1589/jpts.27.967. Epub 2015 Mar 31.

Reference Type BACKGROUND
PMID: 25931771 (View on PubMed)

Norris R, Morrison S, Price A, Pulford S, Meira E, O'Neill S, Williams H, Maddox TW, Carter P, Oldershaw RA. Inline dynamometry provides reliable measurements of quadriceps strength in healthy and ACL-reconstructed individuals and is a valid substitute for isometric electromechanical dynamometry following ACL reconstruction. Knee. 2024 Jan;46:136-147. doi: 10.1016/j.knee.2023.12.006. Epub 2023 Dec 23.

Reference Type DERIVED
PMID: 38142660 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SP0558

Identifier Type: -

Identifier Source: org_study_id

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