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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kforce Link | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KForce Link | Other | Traction (pull-type) dynamometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain During Testing on a Numerical Rating Scale (0-10) | Numerical rating scale of pain from 0 to 10, with 0 indicating no pain (better outcome) and 10 indicating worst pain possible (worse outcome). | 45 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Unable to provide written consent to study participation, or there are contraindications to maximal force testing, including the following:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Norris, BSc | Aintree University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aintree University Hospital | Liverpool | Merseyside | L9 7AL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21570036 | Background | 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. | |
| 22424705 | Background | 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. |
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For inter- and intra-rater reliability of ID in a healthy cohort, 52 participants was recruited from Liverpool University Hospitals, NHS Foundation Trust (LUHFT). For intra-rater reliability and criterion validity in an ACL-reconstructed cohort, consecutive patients presenting to an orthopaedic outpatient clinic following ACL reconstruction, were recruited from LUHFT. Testing sessions were conducted in a LUHFT physiotherapy department between September 2021 and August 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants | Fifty healthy participants tested to determine the inter- and intra-rater reliability of inline dynamometry |
| FG001 | ACL Reconstructed Participants | For intra-rater reliability and criterion validity in an ACL-reconstructed cohort, 52 consecutive patients presenting to an orthopaedic outpatient clinic following ACL reconstruction, with or without concomitant meniscal repair or excision, were recruited from LUHFT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
102 (50 healthy, 52 ACL-reconstructed)
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants | Fifty participants (25 females and 25 males) were recruited to determine the inter- and intra-rater reliability of ID in a healthy cohort |
| BG001 | ACL-reconstructed Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | Newton metres per kg | 30 minutes |
|
Through study completion, on average 12 weeks
As per Clinical trials descriptions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants | Fifty healthy participants tested to determine the inter- and intra-rater reliability of inline dynamometry |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Norris | Liverpool University Hospitals NHS Foundation Trust | 0151529 2534 | richard.norris2@liverpoolft.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2021 | Nov 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 21399535 | Background | 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. |
| 18515915 | Background | 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. |
| 25709864 | Background | 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. |
| 28142362 | Background | 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. |
| 30377716 | Background | 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. |
| 25931771 | Background | 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. |
| 38142660 | Derived | 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. |
Fifty two participants (5 females and 47 males) were recruited to determine the intra-rater reliability and validity of ID in an ACL-reconstructed cohort.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Pain During Testing on a Numerical Rating Scale (0-10) | Numerical rating scale of pain from 0 to 10, with 0 indicating no pain (better outcome) and 10 indicating worst pain possible (worse outcome). | Posted | Median | Inter-Quartile Range | score on a scale | 45 weeks |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | ACL Reconstructed Participants | For intra-rater reliability and criterion validity in an ACL-reconstructed cohort, 56 consecutive patients presenting to an orthopaedic outpatient clinic following ACL reconstruction, with or without concomitant meniscal repair or excision, were recruited from LUHFT. | 0 | 52 | 0 | 52 | 0 | 52 |
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