Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque
Primary Purpose
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
KForce Link
Sponsored by
About this trial
This is an interventional other trial for Anterior Cruciate Ligament Injuries focused on measuring Dynamometer, Dynamometry, Hand held, Inline, Traction, Pull, Validity, Reliability
Eligibility 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.
Sites / Locations
- Aintree University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Kforce Link
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Pain during testing on a numerical rating scale (0-10)
Numerical rating scale of pain with 0 indicating no pain and 10 indicating worst pain possible
Full Information
NCT ID
NCT05109871
First Posted
September 21, 2021
Last Updated
August 5, 2022
Sponsor
Liverpool University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05109871
Brief Title
Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Keywords
Dynamometer, Dynamometry, Hand held, Inline, Traction, Pull, Validity, Reliability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kforce Link
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
KForce Link
Intervention Description
Traction (pull-type) dynamometer
Primary Outcome Measure Information:
Title
Peak knee extensor torque measured in Newton metres per kg (Nm/kg)
Description
Peak knee extensor force (N) multiplied by lever length (m), normalised to body weight (kg)
Time Frame
12-156 Weeks
Secondary Outcome Measure Information:
Title
Pain during testing on a numerical rating scale (0-10)
Description
Numerical rating scale of pain with 0 indicating no pain and 10 indicating worst pain possible
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Norris, BSc
Organizational Affiliation
Aintree University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L9 7AL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21570036
Citation
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.
Results Reference
background
PubMed Identifier
22424705
Citation
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.
Results Reference
background
PubMed Identifier
21399535
Citation
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.
Results Reference
background
PubMed Identifier
18515915
Citation
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.
Results Reference
background
PubMed Identifier
25709864
Citation
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.
Results Reference
background
PubMed Identifier
28142362
Citation
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.
Results Reference
background
PubMed Identifier
30377716
Citation
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.
Results Reference
background
PubMed Identifier
25931771
Citation
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.
Results Reference
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Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque
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