ACL InjuryNCT05294783
The Single Leg Squat Test to Evaluate Dynamic Knee Stability After ACLR
An observational study of ACL Injury, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Patients with anterior cruciate ligament (ACL) injury often suffer knee instability, which can be visualized as a wobbling knee during weight bearing exercises, such as the single leg squat. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2018to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Adult
Study population: Elite or recreational athletes with ACL injury who suffer knee instability and require surgical reconstruction
Who may be able to join
- Aged 18-35;
- Participate in level I or level II sports with a Tegner score of more than 6 before injury(level I: sports involving jumping, cutting and pivoting, e.g.football, basketball etc; Level II: sports involving lateral movements, less pivoting than Level I eg. racket sports)
- Scheduled for ACLR because of unilateral ACL injury;
- Failure to meet any single criteria for a potential coper;
- Contralateral knee without history of injury.
Who cannot join
- Concomitant fracture, meniscus injury or full-thickness chondral injuries;
- preoperative radiographic signs of arthritis;
- Revision ACL surgery;
- With ankle pain, hip pain, low back pain or spine pathology;
- Woman with pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Single Leg Squat and Hold Test With Kinematic Analysis to Evaluate Dynamic Knee Stability in Patients With ACL Injury
Patients with anterior cruciate ligament (ACL) injury often suffer knee instability, which can be visualized as a wobbling knee during weight bearing exercises, such as the single leg squat. We propose to use the single-leg-squat-and-hold (SLSH) task with kinematic analysis to objectively evaluate dynamic knee stability in ACL injured patients. The aim of this study is (1) to compare knee kinematic variations capturing knee wobbling during SLSH between ACL subjects and healthy controls; and (2) to detect the changes in knee kinematic variations during SLSH following ACL reconstruction.
Read the detailed description
Injuries to the anterior cruciate ligament (ACL) are common in pivoting sports such as soccer, handball, basketball and rugby. The ultimate goal of ACL reconstruction for most athletes is return-to-play. Despite successful surgery and a demanding rehabilitation process, some athletes still failed to return to play, and for those who returned to play, some would suffer a second ACL injury. With surgical reconstruction of the ACL, static knee stability can be restored, but dynamic knee stability may not . Patients with ACL injury often experience symptoms such as knee instability, feelings of "giving way" during activities. Biomechanically, dynamic knee stability is considered as the ability to control the relative tibiofemoral displacements during loading.
Regular monitoring of the knee stability before and after ACL reconstruction is necessary for medical personnel to design the most suitable rehabilitation program. In contrast to jumping and hopping tasks, squatting tasks present a similar weight bearing profile during knee flexion, but without the potentially risky landing phase. As poor knee dynamic knee stability can be visualized as a wobbling knee (frequent knee movements). In order to quantitatively and objectively evaluate dynamic knee stability from observing the knee wobbling motion, we propose a single leg squat and hold task(SLSH) with kinematic analysis. Kinematic curve derived from the SLSH involves both the magnitudes and the frequency of the motion fluctuation. This study aims (1) to compare knee kinematic variations capturing knee wobbling during SLSH between ACL-deficient patients who are scheduled for ACLR and healthy controls; and(2)to detect the changes in knee kinematic variations during SLSH following ACLR. We hypothesize that the ACL-deficient patients demonstrate greater knee kinematic variation than the healthy subjects and the knee kinematic variation will reduce after ACLR.
- Conditions
- ACL Injury
- Being tested
- ACL reconstruction
- Keywords
- single leg squat, knee instability, ACL reconstruction, Kinematics
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
ACL reconstruction is a standard surgery for ACL injured patients
| Study group | Role | What they receive |
|---|---|---|
| ACL injured patients | All the ACL injured patients recruited underwent ACL reconstruction with the same group of surgeons lead by the same chief surgeon. Receives: Procedure: ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline knee range of flexion-extension at 3 months after ACLR
knee range of flexion-extension will be measured during 10s holding phase of the single leg squat and hold test
Measured: three months post-operatively
Changes from baseline knee range of varus-valgus at 3 months after ACLR
knee range of virus-valgus will be measured during 10s holding phase of the single leg squat and hold test
Measured: three months post-operatively
Changes from baseline knee range of internal-external rotation at 3 months after ACLR
knee range of internal-external rotation will be measured during 10s holding phase of the single leg squat and hold test
Measured: one month pre-operatively and three months post-operatively
Changes from baseline frequency of knee flexion-extension at 3 months after ACLR
the frequency of the relative flexion-extension movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
Measured: three months post-operatively
Changes from baseline frequency of knee varus-valgus at 3 months after ACLR
the frequency of the relative varus-valgus movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
Measured: three months post-operatively
Changes from baseline frequency of knee internal-external rotation
he frequency of the relative internal-external movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
Measured: three months post-operatively
Secondary outcomes (1)
Changes from baseline International Knee Documentation Committee(IKDC) score at 3 months after ACLR
The IKDC is consisted of 10 questions about symptoms and activity ranging from 0 to 100 where 100 implies perfect knee function
Measured: three months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Jul 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin He, Chinese University of Hong Kong
- Investigators
- Xin HE, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294783
- Sponsor's protocol ID
- 2018.134
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single Leg Squat and Hold Test With Kinematic Analysis to Evaluate Dynamic Knee Stability in Patients With ACL Injury
- ClinicalTrials.gov ID
- NCT05294783
- Acronym / sponsor ID
- 2018.134
- Conditions
- ACL Injury
- Keywords
- single leg squat, knee instability, ACL reconstruction, Kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with anterior cruciate ligament (ACL) injury often suffer knee instability, which can be visualized as a wobbling knee during weight bearing exercises, such as the single leg squat. We propose to use the single-leg-squat-and-hold (SLSH) task with kinematic analysis to objectively evaluate dynamic knee stability in ACL injured patients. The aim of this study is (1) to compare knee kinematic variations capturing knee wobbling during SLSH between ACL subjects and healthy controls; and (2) to detect the changes in knee kinematic variations during SLSH following ACL reconstruction.
Detailed description
Injuries to the anterior cruciate ligament (ACL) are common in pivoting sports such as soccer, handball, basketball and rugby. The ultimate goal of ACL reconstruction for most athletes is return-to-play. Despite successful surgery and a demanding rehabilitation process, some athletes still failed to return to play, and for those who returned to play, some would suffer a second ACL injury. With surgical reconstruction of the ACL, static knee stability can be restored, but dynamic knee stability may not . Patients with ACL injury often experience symptoms such as knee instability, feelings of "giving way" during activities. Biomechanically, dynamic knee stability is considered as the ability to control the relative tibiofemoral displacements during loading.
Regular monitoring of the knee stability before and after ACL reconstruction is necessary for medical personnel to design the most suitable rehabilitation program. In contrast to jumping and hopping tasks, squatting tasks present a similar weight bearing profile during knee flexion, but without the potentially risky landing phase. As poor knee dynamic knee stability can be visualized as a wobbling knee (frequent knee movements). In order to quantitatively and objectively evaluate dynamic knee stability from observing the knee wobbling motion, we propose a single leg squat and hold task(SLSH) with kinematic analysis. Kinematic curve derived from the SLSH involves both the magnitudes and the frequency of the motion fluctuation. This study aims (1) to compare knee kinematic variations capturing knee wobbling during SLSH between ACL-deficient patients who are scheduled for ACLR and healthy controls; and(2)to detect the changes in knee kinematic variations during SLSH following ACLR. We hypothesize that the ACL-deficient patients demonstrate greater knee kinematic variation than the healthy subjects and the knee kinematic variation will reduce after ACLR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL injured patients | – | Procedure: ACL reconstructionAll the ACL injured patients recruited underwent ACL reconstruction with the same group of surgeons lead by the same chief surgeon. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- Elite or recreational athletes with ACL injury who suffer knee instability and require surgical reconstruction
Key inclusion criteria (5 listed)
- Aged 18-35;
- Participate in level I or level II sports with a Tegner score of more than 6 before injury(level I: sports involving jumping, cutting and pivoting, e.g.football, basketball etc; Level II: sports involving lateral movements, less pivoting than Level I eg. racket sports)
- Scheduled for ACLR because of unilateral ACL injury;
- Failure to meet any single criteria for a potential coper;
- Contralateral knee without history of injury.
Key exclusion criteria (5 listed)
- Concomitant fracture, meniscus injury or full-thickness chondral injuries;
- preoperative radiographic signs of arthritis;
- Revision ACL surgery;
- With ankle pain, hip pain, low back pain or spine pathology;
- Woman with pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstructionACL reconstruction is a standard surgery for ACL injured patients | Procedure or surgery | ACL injured patients |
Primary outcome
Changes from baseline knee range of flexion-extension at 3 months after ACLR
Time frame: three months post-operatively
knee range of flexion-extension will be measured during 10s holding phase of the single leg squat and hold test
Changes from baseline knee range of varus-valgus at 3 months after ACLR
Time frame: three months post-operatively
knee range of virus-valgus will be measured during 10s holding phase of the single leg squat and hold test
Changes from baseline knee range of internal-external rotation at 3 months after ACLR
Time frame: one month pre-operatively and three months post-operatively
knee range of internal-external rotation will be measured during 10s holding phase of the single leg squat and hold test
Changes from baseline frequency of knee flexion-extension at 3 months after ACLR
Time frame: three months post-operatively
the frequency of the relative flexion-extension movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
Changes from baseline frequency of knee varus-valgus at 3 months after ACLR
Time frame: three months post-operatively
the frequency of the relative varus-valgus movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
Changes from baseline frequency of knee internal-external rotation
Time frame: three months post-operatively
he frequency of the relative internal-external movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test
1 secondary outcome
Changes from baseline International Knee Documentation Committee(IKDC) score at 3 months after ACLR
Time frame: three months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
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Preventing Injured Knees From osteoArthritis: Severity Outcomes
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ACL Tear
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin HE, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline knee range of flexion-extension at 3 months after ACLR (time frame: three months post-operatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.