Trial Outcomes & Findings for Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque (NCT NCT05109871)

NCT ID: NCT05109871

Last Updated: 2025-05-01

Results Overview

Peak knee extensor force (N) multiplied by lever length (m), normalised to body weight (kg)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2025-05-01

Participant Flow

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.

Participant milestones

Measure	Healthy Participants Fifty healthy participants tested to determine the inter- and intra-rater reliability of inline dynamometry	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.
Overall Study STARTED	50	52
Overall Study COMPLETED	50	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Healthy Participants n=50 Participants Fifty participants (25 females and 25 males) were recruited to determine the inter- and intra-rater reliability of ID in a healthy cohort	ACL-reconstructed Participants n=52 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.	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	52 Participants n=7 Participants	102 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	5 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	47 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	49 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	50 participants n=5 Participants	52 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Peak knee extensor force (N) multiplied by lever length (m), normalised to body weight (kg)

Outcome measures

Measure	Healthy Participants n=50 Participants Fifty healthy participants tested to determine the inter- and intra-rater reliability of inline dynamometry	ACL Reconstructed Participants n=52 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.
Peak Knee Extensor Torque Measured in Newton Metres Per kg (Nm/kg)	3.12 Newton metres per kg Standard Deviation 0.66	2.66 Newton metres per kg Standard Deviation 0.66

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Healthy Participants n=50 Participants Fifty healthy participants tested to determine the inter- and intra-rater reliability of inline dynamometry	ACL Reconstructed Participants n=52 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.
Pain During Testing on a Numerical Rating Scale (0-10)	1 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 3.0

Adverse Events

Healthy Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACL Reconstructed Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Norris

Liverpool University Hospitals NHS Foundation Trust

Phone: 0151529 2534

Email: richard.norris2@liverpoolft.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place