Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Conditions
Keywords
Dynamometer, Dynamometry, Hand held, Inline, Traction, Pull, Validity, Reliability
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.
Interventions
OTHERKForce Link
Traction (pull-type) dynamometer
Sponsors
Liverpool University Hospitals NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Knee Extensor Torque Measured in Newton Metres Per kg (Nm/kg) | 30 minutes | Peak knee extensor force (N) multiplied by lever length (m), normalised to body weight (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain During Testing on a Numerical Rating Scale (0-10) | 45 weeks | Numerical rating scale of pain from 0 to 10, with 0 indicating no pain (better outcome) and 10 indicating worst pain possible (worse outcome). |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| ACL-reconstructed Participants 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. | 52 |
| Total | 102 |
Baseline characteristics
| Characteristic | Healthy Participants | ACL-reconstructed Participants | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 52 Participants | 102 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 49 Participants | 96 Participants |
| Region of Enrollment United Kingdom | 50 participants | 52 participants | 102 participants |
| Sex: Female, Male Female | 25 Participants | 5 Participants | 30 Participants |
| Sex: Female, Male Male | 25 Participants | 47 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 52 |
| other Total, other adverse events | 0 / 50 | 0 / 52 |
| serious Total, serious adverse events | 0 / 50 | 0 / 52 |
Outcome results
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)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants | Peak Knee Extensor Torque Measured in Newton Metres Per kg (Nm/kg) | 3.12 Newton metres per kg | Standard Deviation 0.66 |
| ACL Reconstructed Participants | Peak Knee Extensor Torque Measured in Newton Metres Per kg (Nm/kg) | 2.66 Newton metres per kg | Standard Deviation 0.66 |
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).
Time frame: 45 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Participants | Pain During Testing on a Numerical Rating Scale (0-10) | 1 score on a scale |
| ACL Reconstructed Participants | Pain During Testing on a Numerical Rating Scale (0-10) | 1 score on a scale |