NCT04633161

Brief Summary

This project aims to compare the difference in muscle strength, muscle elasticity and muscle coordination of quadriceps and hamstring muscle and their association with knee biomechanics during single leg hop landing in patients with anterior cruciate ligament reconstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 11, 2020

Last Update Submit

November 11, 2020

Conditions

Keywords

muscle strengthmuscle elasticitymuscle coordinationknee stability

Outcome Measures

Primary Outcomes (4)

  • knee biomechanics during single leg hop landing

    knee kinematics(peak knee flexion, knee valgus, knee internal rotation, knee flexion excursion, valgus excursion and internal excursion) and kinetics(vertical ground reaction force, knee extension moment, knee valgus moment) were collected by 3D motion analysis system(VICON) during the landing phase of single leg hop test

    post-operatively 6-18 months

  • muscle strength

    muscle peak torque of knee extension and knee flexion at 60°/s and 180°/s tested with isokinetic mode by Biodex

    post-operatively 6-18 months

  • muscle elasticity

    muscle shear elastic modulus of vastus medialis, rectus femoris, vastus lateralis, semimembranosus,semitendinosus and biceps femoris was measured by ultrasound shear wave elastography

    post-operatively 6-18 months

  • muscle coordination

    muscle activity level and onset time of vastus medialis, vastus lateralis, semimembranosus,and biceps femoris was assessed by electromyography(EMG) during the landing phase of single leg hop test

    post-operatively 6-18 months

Secondary Outcomes (3)

  • knee laxity

    post-operatively 6-18 months

  • subjective knee function

    post-operatively 6-18 months

  • Psychological readiness for return-to-play

    post-operatively 6-18 months

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-report of gender identity
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young and active ACL patients within their post-ACLR 6-18 months

You may qualify if:

  • (1) Male aged 18-35 (2) With pre-injury activity level of more than 6 in Tegner score (3) Within their post-operative 6-18 months (4) Without injury history for the contralateral limb

You may not qualify if:

  • (1) With concomitant fracture, meniscus injury or chondral lesion (2) With preoperative radiographic signs of arthritis (3) With revision ACL surgery (4) With injury history of the spine or hamstring strain during the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 18, 2020

Study Start

August 1, 2019

Primary Completion

August 31, 2019

Study Completion

January 31, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations