NCT05109871

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

September 21, 2021

Results QC Date

November 23, 2022

Last Update Submit

April 11, 2025

Conditions

Keywords

DynamometerDynamometryHand heldInlineTractionPullValidityReliability

Outcome Measures

Primary Outcomes (1)

  • Peak Knee Extensor Torque Measured in Newton Metres Per kg (Nm/kg)

    Peak knee extensor force (N) multiplied by lever length (m), normalised to body weight (kg)

    30 minutes

Secondary Outcomes (1)

  • Pain During Testing on a Numerical Rating Scale (0-10)

    45 weeks

Study Arms (1)

Kforce Link

EXPERIMENTAL
Other: KForce Link

Interventions

Traction (pull-type) dynamometer

Kforce Link

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aintree University Hospital

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Related Publications (9)

  • 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.

    PMID: 21570036BACKGROUND
  • 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.

    PMID: 22424705BACKGROUND
  • 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.

    PMID: 21399535BACKGROUND
  • 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.

    PMID: 18515915BACKGROUND
  • 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.

    PMID: 25709864BACKGROUND
  • 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.

    PMID: 28142362BACKGROUND
  • 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.

    PMID: 30377716BACKGROUND
  • 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.

    PMID: 25931771BACKGROUND
  • 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.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Results Point of Contact

Title
Richard Norris
Organization
Liverpool University Hospitals NHS Foundation Trust

Study Officials

  • Richard Norris, BSc

    Aintree University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

November 5, 2021

Study Start

September 20, 2021

Primary Completion

August 1, 2022

Study Completion

August 2, 2022

Last Updated

May 1, 2025

Results First Posted

May 1, 2025

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations