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

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ClinicalTrials.gov Identifier: NCT05109871
Recruitment Status : Completed
First Posted : November 5, 2021
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
Liverpool University Hospitals NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear Other: KForce Link Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective Cross-sectional Study to Determine the Reliability and Validity of Inline 'Pull' Dynamometry for Measuring Peak Knee Extensor Torque in Patients Following Anterior Cruciate Ligament (ACL) Reconstruction: HRA & HCRW Approval Issued.
Actual Study Start Date : September 20, 2021
Actual Primary Completion Date : August 1, 2022
Actual Study Completion Date : August 2, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Kforce Link Other: KForce Link
Traction (pull-type) dynamometer


Outcome Measures
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Primary Outcome Measures :
  1. Peak knee extensor torque measured in Newton metres per kg (Nm/kg) [ Time Frame: 12-156 Weeks ]
    Peak knee extensor force (N) multiplied by lever length (m), normalised to body weight (kg)


Secondary Outcome Measures :
  1. Pain during testing on a numerical rating scale (0-10) [ Time Frame: 12 weeks ]
    Numerical rating scale of pain with 0 indicating no pain and 10 indicating worst pain possible


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • No contraindications to maximal force testing (see 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05109871


Locations
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United Kingdom
Aintree University Hospital
Liverpool, Merseyside, United Kingdom, L9 7AL
Sponsors and Collaborators
Liverpool University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Richard Norris, BSc Aintree University Hospital
More Information
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Publications:

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Responsible Party: Liverpool University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05109871    
Other Study ID Numbers: SP0558
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Liverpool University Hospitals NHS Foundation Trust:
Dynamometer
Dynamometry
Hand held
Inline
 Traction
Pull
Validity
Reliability
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries