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
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|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear||Other: KForce Link||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Kforce Link||
Other: KForce Link
Traction (pull-type) dynamometer
- 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)
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
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.
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
|Aintree University Hospital|
|Liverpool, Merseyside, United Kingdom, L9 7AL|
|Principal Investigator:||Richard Norris, BSc||Aintree University Hospital|
|Responsible Party:||Liverpool University Hospitals NHS Foundation Trust|
|Other Study ID Numbers:||
|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|
|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|
Anterior Cruciate Ligament Injuries
Wounds and Injuries